COMPASS - COpenhagen MenoPAuSe Study

Browse trials for

• Osteoporosis, Postmenopausal 334

Osteoporosis, Postmenopausal

334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.

This study's planned enrollment of 192 is above the median of 119 across 264 interventional studies indexed under Osteoporosis, Postmenopausal.

Lead sponsor

Martin Blomberg Jensen is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Study arms

• Active comparator
  GnRH analog

  Pamorelin 11.25 mg intramuscular injection once + Daily placebo gel

  Drug: Triptorelin 11.25 mg · Drug: Placebo gel

• Placebo comparator
  Placebo

  Saline intramuscular injection once + Daily placebo gel

  Drug: Sodium Chloride 0.9% · Drug: Placebo gel

• Active comparator
  Transdermal Estrogen

  Saline intramuscular injection once + Estreva gel 1.5 mg daily

  Drug: Sodium Chloride 0.9% · Drug: Estradiol (E2)

• Active comparator
  Transdermal testosterone

  Saline intramuscular injection once + Tostran gel 10 mg every other day + placebo gel every other day

  Drug: Sodium Chloride 0.9% · Drug: Testosterone · Drug: Placebo gel

Interventions

• DrugTriptorelin 11.25 mg

  Pamorelin 11.25 mg intramuscular injection once

  Also known as: Pamorelin

• DrugSodium Chloride 0.9%

  Saline intramuscular injection once

  Also known as: Saline

• DrugEstradiol (E2)

  Estreva gel 1.5 mg daily

  Also known as: Estreva

• DrugTestosterone

  Tostran gel 10 mg every other day

  Also known as: Tostran

• DrugPlacebo gel

  Placebo gel every day or every other day

Primary outcomes

1. Change in bone remodeling from baseline to week 8.

   Change in bone remodeling defined by change in bone marker (ΔCTX) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1. GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2. Combined analysis of all 4 arms of the RCT 3. GnRH analog and estradiol 4. GnRH analog and testosterone 5. Estradiol and placebo 6. Testosterone and placebo 7. Estradiol and testosterone

   Time frame: From baseline to week 8

2. Change in bone remodeling from baseline to week 8.

   Change in bone remodeling defined by change in bone marker (ΔP1NP) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: From baseline to week 8

3. Change in bone remodeling from baseline to week 8

   Change in bone remodeling defined by change in bone marker-ratios (ΔCTX/ΔP1NP, and ΔBBI) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: From baseline to week 8

Secondary outcomes

1. Change in serum levels of Hypothalamic-Pituitary-Adrenal (HPA) axis from baseline to week 8

   Change in serum levels of Hypothalamic-Pituitary-Adrenal (HPA) axis from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 8

2. Change in serum levels of Hypothalamic-Pituitary-Gonadal (HPG) axis from baseline to week 8

   Change in serum levels of Hypothalamic-Pituitary-Gonadal (HPG) axis from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 8

3. Change in serum levels of Hypothalamic-Pituitary-Thyroid (HPT) axis from baseline to week 8

   Change in serum levels of Hypothalamic-Pituitary-Thyroid (HPT) axis from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 8

4. Change in quality of life evaluated with MENQOL-1 from baseline to week 8

   Change in quality of life evaluated with The Menopause-specific Quality of Life (MENQOL) Questionnaire from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. MENQOL is ranging from 0 (asymptomatic woman) to 232 (extremely bothered).

   Time frame: Baseline to week 8

5. Change in sexual function evaluated with female sexual function index from baseline to week 8

   Change in sexual function evaluated with female sexual function index (FSFI) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. The FSFI use a 5-point Likert scale with higher scores indicating greater levels of sexual functioning on the respective item. The possible range is 2-36.

   Time frame: Baseline to week 8

6. Change in sexual function evaluated with female sexual distress scale-revised from baseline to week 8

   Change in sexual function evaluated with female sexual distress scale-revised (FSDS-R) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. FSDS-R has a total score ranging from 0 to 52, with higher scores indicating more sexually related distress.

   Time frame: Baseline to week 8

7. Change in depressive symptoms evaluated by MDI from baseline to week 8

   Change in depressive symptoms evaluated by Major Depression Inventory (MDI) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Total score between 0 (no depression) to 50 (maximum depressed).

   Time frame: Baseline to week 8

8. Change in depressive symptoms evaluated by CES-D from baseline to week 8

   Description: Change in depressive symptoms evaluated by Center for Epidemiologic Studies Depression Scale (CES-D) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

   Time frame: Baseline to week 8

9. Change in anxiety symptoms evaluated by GAD-7 from baseline to week 8

   Change in anxiety symptoms evaluated by General Anxiety Disorder-7 (GAD-7) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Scores ranges from 0 (No anxiety) to 21 (severe anxiety).

   Time frame: Baseline to week 8

10. Change in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) from baseline to week 8

    Change in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Scores ranges from 8-40. Higher scores indicate more severe sleep disturbance.

    Time frame: Baseline to week 8

11. Change in thyroid hormones from baseline to week 4 and 8

    Change in thyroid hormones from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8.

12. Change in urine calcium from baseline to weeks 4 and 8

    Change in urine calcium from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8

13. Change in urine creatinine from baseline to weeks 4 and 8

    Change in urine creatinine from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8.

14. Change in urine phosphate from baseline to weeks 4 and 8

    Change in urine phosphate from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8

15. Change in urine magnesium from baseline to weeks 4 and 8

    Change in urine magnesium from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8

16. Change in urine sodium from baseline to weeks 4 and 8

    Change in urine sodium from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8

17. Change in urine cortisol and other hormones from baseline to weeks 4 and 8

    Change in urine cortisol and other hormones from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8.

18. Change in serum ionized calcium from baseline to week 4 and 8

    Change in serum ionized calcium from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

19. Change in serum calcium from baseline to week 4 and 8

    Change in serum calcium from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

20. Change in serum albumin from baseline to week 4 and 8

    Change in serum albumin from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

21. Change in serum PTH from baseline to week 4 and 8

    Change in serum PTH from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

22. Change in serum phosphate from baseline to week 4 and 8

    Change in serum phosphate from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

23. Change in serum vitamin D metabolites from baseline to week 4 and 8

    Change in serum vitamin D metabolites from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

24. Change in serum hCG from baseline to week 4 and 8

    Change in serum hCG from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

25. Change in thyroid hormone conversion (DIO2 activity) in fat cells determined by their conversion of T4 to T3 from baseline to week 8

    Change in thyroid hormone conversion (DIO2 activity) in fat cells determined by their conversion of T4 to T3 from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 8

26. Change in adrenal hormones from baseline to week 4 and 8

    Change in adrenal hormones from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

27. Change in the mean frequency of moderate to severe VMS from Baseline to week 8

    Change in the mean frequency of moderate to severe VMS from Baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Definition of moderate VMS: Moderate VMS is defined as a sensation of heat with sweating/dampness, but the woman is able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Definition of severe VMS: Severe VMS is defined as sensation of intense heat with sweating, caused disruption of activity. If at night

    Time frame: Baseline to week 8

28. Change in the mean frequency of moderate to severe VMS from Baseline to week 4

    Change in the mean frequency of moderate to severe VMS from Baseline to week 4. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Definition of moderate VMS: Moderate VMS is defined as a sensation of heat with sweating/dampness, but the woman is able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Definition of severe VMS: Severe VMS is defined as sensation of intense heat with sweating, caused disruption of activity. If at night

    Time frame: Baseline to week 4

29. Change in the mean severity-score from Baseline to week 8

    Change in the mean severity-score from Baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Definition of mean severity-score of VMS: Severity score of moderate to severe VMS per day was calculated as follows: ((number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3))/Total number of daily hot flashes.

    Time frame: Baseline to week 8

30. Change in the mean severity-score from Baseline to week 4

    Change in the mean severity-score from Baseline to week 4. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Definition of mean severity-score of VMS: Severity score of moderate to severe VMS per day was calculated as follows: ((number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3))/Total number of daily hot flashes.

    Time frame: Baseline to week 4

31. Change in VMS measured by the Greene Climacteric Scale (GCS) from baseline to week 8

    Change in VMS measured using the questionnaire: The Greene Climacteric Scale (GCS) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Ranging from 0 (when every symptom is rated as "not at all") to a maximum of 63 (when every symptom is rated as "very often")

    Time frame: Baseline to week 8

32. Change in serum LH from baseline to weeks 4 and 8

    Change in serum LH from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8

33. Change in serum FSH from baseline to weeks 4 and 8

    Change in serum FSH from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8

34. Change in serum estradiol from baseline to week 4 and 8

    Change in serum estradiol from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

35. Change in serum SHGB from baseline to week 4 and 8

    Change in serum SHGB from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

36. Change in physical strength tests from baseline to weeks 4 and 8.

    Change in physical strength test measured by 30 second Sit-To-Stand-Test (STST) from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. Unit: number of stands/30 seconds.

    Time frame: Baseline to weeks 4 and 8.

37. Change in physical strength tests from baseline to weeks 4 and 8.

    Change in physical strength test measured by Hand-grip strength (HGS) from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone. HGS will be evaluated using a digital hand-grip dynamometer measuring the absolute (kilograms-force) and relative (kilograms/weight in kilograms) grip strength

    Time frame: Baseline to weeks 4 and 8.

38. Change in androgens from baseline to weeks 4 and 8

    Change in androgens including 11 oxygenated androgens measured by LCMS from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone.

    Time frame: Baseline to weeks 4 and 8.

Other outcomes

1. Change in fasting insulin from baseline to week 8

   Change in fasting insulin from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 8

2. Change in HbA1C from baseline to week 8

   Change in HbA1C (mmol/mol) from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 8

3. Change in HOMA-IR from baseline to week 8

   Change in HOMA-IR from baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone.

   Time frame: Baseline to week 8

4. Change in total cholesterol, cholesterol (total, HDL, LDL), and triglycerides from baseline to week 4 and 8

   Change in total cholesterol, cholesterol (total, HDL, LDL), and triglycerides from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 4 and 8

5. Change in serum RANKL from baseline to weeks 4 and 8

   Change in serum RANKL from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to weeks 4 and 8

6. Change in serum creatinine from baseline to week 4 and 8

   Change in serum creatinine from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 4 and 8

7. Change in serum sodium from baseline to week 4 and 8

   Change in serum sodium from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 4 and 8

8. Change in serum potassium from baseline to week 4 and 8

   Change in serum potassium from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 4 and 8

9. Change in serum urea from baseline to week 4 and 8

   Change in serum urea from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

   Time frame: Baseline to week 4 and 8

10. Change in hepatic enzymes (ALAT, ASAT, GGT, alkaline phosphatase) from baseline to week 4 and 8

    Change in hepatic enzymes (ALAT, ASAT, GGT, alkaline phosphatase) from baseline to week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 4 and 8

11. Change in QTc using electrocardiogram (ECG) at baseline to week 8

    Change in QTc using electrocardiogram (ECG) at baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 8

12. Change in weight at baseline to week 8

    Change in weight at baseline to week 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 8

13. Change in RNA expression (RNAseq) in abdominal fat (abdominal fat biopsies) from baseline to week 8 and following in vitro stimulation with hormones and treatments such as LH/hCG

    Change in RNA expression (RNAseq) in abdominal fat (abdominal fat biopsies) from baseline to week 8 and following in vitro stimulation with hormones and treatments such as LH/hCG. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to week 8

14. Change in Cerebral Spinal Fluid (CSF) hormone, mineral or neuropeptide levels between all 4 treatment arms at week 8

    Change in Cerebral Spinal Fluid (CSF) hormone, mineral or neuropeptide levels between all 4 treatment arms at week 8.

    Time frame: between all 4 treatment arms at week 8

15. Change in frequency and type of reported adverse events between baseline and week 4 and 8

    Change in frequency and type of reported adverse events between baseline and week 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline and week 4 and 8

16. Change in ECG pattern from screening to week 4.

    Change in ECG pattern from screening to week 4. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Screening to week 4.

17. Change in serum FGF23 from baseline to weeks 4 and 8

    Change in serum FGF23 from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8

18. Change in Klotho from baseline to weeks 4 and 8

    Change in Klotho from baseline to weeks 4 and 8. The following primary, secondary and exploratory endpoints will all be investigated as comparisons first and foremost between: 1) GnRH analog and placebo-group. After the first analysis between GnRH-analog group and placebo, the outcomes will be investigated between the groups in the following order: 2) Combined analysis of all 4 arms of the RCT 3) GnRH analog and estradiol 4) GnRH analog and testosterone 5) Estradiol and placebo 6) Testosterone and placebo 7) Estradiol and testosterone

    Time frame: Baseline to weeks 4 and 8

Publications

• Rosen HN, Moses AC, Garber J, Iloputaife ID, Ross DS, Lee SL, Greenspan SL. Serum CTX: a new marker of bone resorption that shows treatment effect more often than other markers because of low coefficient of variability and large changes with bisphosphonate therapy. Calcif Tissue Int. 2000 Feb;66(2):100-3. doi: 10.1007/pl00005830. PubMed 10652955 ↗
• Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowinska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2025 May 19;110(6):e1951-e1958. doi: 10.1210/clinem/dgae611. PubMed 39243386 ↗
• Kline GA, Holmes DT. Bone turnover markers for assessment of anti-resorptive effect in clinical practice: A good idea meets the problem of measurement uncertainty. Clin Biochem. 2023 Jun;116:100-104. doi: 10.1016/j.clinbiochem.2023.04.007. Epub 2023 Apr 19. PubMed 37084998 ↗
• Brown JP, Don-Wauchope A, Douville P, Albert C, Vasikaran SD. Current use of bone turnover markers in the management of osteoporosis. Clin Biochem. 2022 Nov-Dec;109-110:1-10. doi: 10.1016/j.clinbiochem.2022.09.002. Epub 2022 Sep 9. PubMed 36096182 ↗
• Migliorini F, Maffulli N, Spiezia F, Peretti GM, Tingart M, Giorgino R. Potential of biomarkers during pharmacological therapy setting for postmenopausal osteoporosis: a systematic review. J Orthop Surg Res. 2021 May 31;16(1):351. doi: 10.1186/s13018-021-02497-0. PubMed 34059108 ↗
• Everts-Graber J, Reichenbach S, Ziswiler HR, Studer U, Lehmann T. A Single Infusion of Zoledronate in Postmenopausal Women Following Denosumab Discontinuation Results in Partial Conservation of Bone Mass Gains. J Bone Miner Res. 2020 Jul;35(7):1207-1215. doi: 10.1002/jbmr.3962. Epub 2020 Feb 11. PubMed 31991007 ↗
• Tsourdi E, Langdahl B, Cohen-Solal M, Aubry-Rozier B, Eriksen EF, Guanabens N, Obermayer-Pietsch B, Ralston SH, Eastell R, Zillikens MC. Discontinuation of Denosumab therapy for osteoporosis: A systematic review and position statement by ECTS. Bone. 2017 Dec;105:11-17. doi: 10.1016/j.bone.2017.08.003. Epub 2017 Aug 5. PubMed 28789921 ↗
• Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11. PubMed 19671655 ↗
• Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266. PubMed 22250775 ↗
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PubMed 16717171 ↗
• Greene JG. A factor analytic study of climacteric symptoms. J Psychosom Res. 1976;20(5):425-30. doi: 10.1016/0022-3999(76)90005-2. No abstract available. PubMed 1003364 ↗
• Derogatis LR, Rosen R, Leiblum S, Burnett A, Heiman J. The Female Sexual Distress Scale (FSDS): initial validation of a standardized scale for assessment of sexually related personal distress in women. J Sex Marital Ther. 2002 Jul-Sep;28(4):317-30. doi: 10.1080/00926230290001448. PubMed 12082670 ↗
• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597. PubMed 10782451 ↗
• Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8. PubMed 8844630 ↗
• Radtke JV, Terhorst L, Cohen SM. The Menopause-Specific Quality of Life Questionnaire: psychometric evaluation among breast cancer survivors. Menopause. 2011 Mar;18(3):289-95. doi: 10.1097/gme.0b013e3181ef975a. PubMed 20881889 ↗
• Shieh A, Karlamangla AS, Gossiel F, Eastell R, Burnett-Bowie SA, Greendale GA. Estimating Net Bone Formation Relative to Resorption Using Reference Bone Turnover Markers. J Clin Endocrinol Metab. 2025 Jul 15;110(8):e2544-e2552. doi: 10.1210/clinem/dgae842. PubMed 39657000 ↗
• Nathorst-Boos J, Floter A, Jarkander-Rolff M, Carlstrom K, Schoultz Bv. Treatment with percutanous testosterone gel in postmenopausal women with decreased libido--effects on sexuality and psychological general well-being. Maturitas. 2006 Jan 10;53(1):11-8. doi: 10.1016/j.maturitas.2005.01.002. Epub 2005 Sep 23. PubMed 16183220 ↗
• Donovitz G, Cotten M. Breast Cancer Incidence Reduction in Women Treated with Subcutaneous Testosterone: Testosterone Therapy and Breast Cancer Incidence Study. Eur J Breast Health. 2021 Mar 31;17(2):150-156. doi: 10.4274/ejbh.galenos.2021.6213. eCollection 2021 Apr. PubMed 33870115 ↗
• Glaser RL, York AE, Dimitrakakis C. Incidence of invasive breast cancer in women treated with testosterone implants: a prospective 10-year cohort study. BMC Cancer. 2019 Dec 30;19(1):1271. doi: 10.1186/s12885-019-6457-8. PubMed 31888528 ↗
• Goldstat R, Briganti E, Tran J, Wolfe R, Davis SR. Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women. Menopause. 2003 Sep-Oct;10(5):390-8. doi: 10.1097/01.GME.0000060256.03945.20. PubMed 14501599 ↗
• El-Hage G, Eden JA, Manga RZ. A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder. Climacteric. 2007 Aug;10(4):335-43. doi: 10.1080/13697130701364644. PubMed 17653960 ↗
• Simon J, Braunstein G, Nachtigall L, Utian W, Katz M, Miller S, Waldbaum A, Bouchard C, Derzko C, Buch A, Rodenberg C, Lucas J, Davis S. Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder. J Clin Endocrinol Metab. 2005 Sep;90(9):5226-33. doi: 10.1210/jc.2004-1747. Epub 2005 Jul 12. PubMed 16014407 ↗
• Panay N, Al-Azzawi F, Bouchard C, Davis SR, Eden J, Lodhi I, Rees M, Rodenberg CA, Rymer J, Schwenkhagen A, Sturdee DW. Testosterone treatment of HSDD in naturally menopausal women: the ADORE study. Climacteric. 2010 Apr;13(2):121-31. doi: 10.3109/13697131003675922. PubMed 20166859 ↗
• Shifren JL, Davis SR, Moreau M, Waldbaum A, Bouchard C, DeRogatis L, Derzko C, Bearnson P, Kakos N, O'Neill S, Levine S, Wekselman K, Buch A, Rodenberg C, Kroll R. Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women: results from the INTIMATE NM1 Study. Menopause. 2006 Sep-Oct;13(5):770-9. doi: 10.1097/01.gme.0000243567.32828.99. PubMed 16932240 ↗
• Hofling M, Lundstrom E, Azavedo E, Svane G, Hirschberg AL, von Schoultz B. Testosterone addition during menopausal hormone therapy: effects on mammographic breast density. Climacteric. 2007 Apr;10(2):155-63. doi: 10.1080/13697130701258812. PubMed 17453864 ↗
• Fooladi E, Bell RJ, Jane F, Robinson PJ, Kulkarni J, Davis SR. Testosterone improves antidepressant-emergent loss of libido in women: findings from a randomized, double-blind, placebo-controlled trial. J Sex Med. 2014 Mar;11(3):831-9. doi: 10.1111/jsm.12426. Epub 2014 Jan 16. PubMed 24433574 ↗
• Davis SR, Hirschberg AL, Wagner LK, Lodhi I, von Schoultz B. The effect of transdermal testosterone on mammographic density in postmenopausal women not receiving systemic estrogen therapy. J Clin Endocrinol Metab. 2009 Dec;94(12):4907-13. doi: 10.1210/jc.2009-1523. Epub 2009 Oct 22. PubMed 19850682 ↗
• Davis SR, van der Mooren MJ, van Lunsen RH, Lopes P, Ribot C, Rees M, Moufarege A, Rodenberg C, Buch A, Purdie DW. Efficacy and safety of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial. Menopause. 2006 May-Jun;13(3):387-96. doi: 10.1097/01.gme.0000179049.08371.c7. PubMed 16735935 ↗
• Buster JE, Kingsberg SA, Aguirre O, Brown C, Breaux JG, Buch A, Rodenberg CA, Wekselman K, Casson P. Testosterone patch for low sexual desire in surgically menopausal women: a randomized trial. Obstet Gynecol. 2005 May;105(5 Pt 1):944-52. doi: 10.1097/01.AOG.0000158103.27672.0d. PubMed 15863529 ↗
• Kocoska-Maras L, Hirschberg AL, Bystrom B, Schoultz BV, Radestad AF. Testosterone addition to estrogen therapy - effects on inflammatory markers for cardiovascular disease. Gynecol Endocrinol. 2009 Dec;25(12):823-7. doi: 10.3109/09513590903056134. PubMed 19906002 ↗
• Floter A, Nathorst-Boos J, Carlstrom K, Ohlsson C, Ringertz H, Schoultz Bv. Effects of combined estrogen/testosterone therapy on bone and body composition in oophorectomized women. Gynecol Endocrinol. 2005 Mar;20(3):155-60. doi: 10.1080/09513590400021193. PubMed 16019355 ↗
• Floter A, Nathorst-Boos J, Carlstrom K, von Schoultz B. Addition of testosterone to estrogen replacement therapy in oophorectomized women: effects on sexuality and well-being. Climacteric. 2002 Dec;5(4):357-65. PubMed 12626215 ↗
• Moller MC, Bartfai AB, Radestad AF. Effects of testosterone and estrogen replacement on memory function. Menopause. 2010 Sep-Oct;17(5):983-9. doi: 10.1097/gme.0b013e3181dc2e40. PubMed 20555288 ↗
• Moller MC, Radestad AF, von Schoultz B, Bartfai A. Effect of estrogen and testosterone replacement therapy on cognitive fatigue. Gynecol Endocrinol. 2013 Feb;29(2):173-6. doi: 10.3109/09513590.2012.730568. Epub 2012 Oct 25. PubMed 23095007 ↗
• Dias RS, Kerr-Correa F, Moreno RA, Trinca LA, Pontes A, Halbe HW, Gianfaldoni A, Dalben IS. Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: a double-blind controlled pilot study. Menopause. 2006 Mar-Apr;13(2):202-11. doi: 10.1097/01.gme.0000198491.34371.9c. PubMed 16645534 ↗
• Shifren JL, Braunstein GD, Simon JA, Casson PR, Buster JE, Redmond GP, Burki RE, Ginsburg ES, Rosen RC, Leiblum SR, Caramelli KE, Mazer NA. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med. 2000 Sep 7;343(10):682-8. doi: 10.1056/NEJM200009073431002. PubMed 10974131 ↗
• Wisniewski AB, Nguyen TT, Dobs AS. Evaluation of high-dose estrogen and high-dose estrogen plus methyltestosterone treatment on cognitive task performance in postmenopausal women. Horm Res. 2002;58(3):150-5. doi: 10.1159/000064491. PubMed 12218381 ↗
• Penteado SR, Fonseca AM, Bagnoli VR, Abdo CH, Junior JM, Baracat EC. Effects of the addition of methyltestosterone to combined hormone therapy with estrogens and progestogens on sexual energy and on orgasm in postmenopausal women. Climacteric. 2008 Feb;11(1):17-25. doi: 10.1080/13697130701741932. PubMed 18202961 ↗
• Leao LM, Duarte MP, Silva DM, Bahia PR, Coeli CM, de Farias ML. Influence of methyltestosterone postmenopausal therapy on plasma lipids, inflammatory factors, glucose metabolism and visceral fat: a randomized study. Eur J Endocrinol. 2006 Jan;154(1):131-9. doi: 10.1530/eje.1.02065. PubMed 16382002 ↗
• de Paula FJ, Soares JM Jr, Haidar MA, de Lima GR, Baracat EC. The benefits of androgens combined with hormone replacement therapy regarding to patients with postmenopausal sexual symptoms. Maturitas. 2007 Jan 20;56(1):69-77. doi: 10.1016/j.maturitas.2006.06.005. Epub 2006 Jul 5. PubMed 16822626 ↗
• Basaria S, Nguyen T, Rosenson RS, Dobs AS. Effect of methyl testosterone administration on plasma viscosity in postmenopausal women. Clin Endocrinol (Oxf). 2002 Aug;57(2):209-14. doi: 10.1046/j.1365-2265.2002.01584.x. PubMed 12153599 ↗
• Islam RM, Bell RJ, Green S, Page MJ, Davis SR. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol. 2019 Oct;7(10):754-766. doi: 10.1016/S2213-8587(19)30189-5. Epub 2019 Jul 25. PubMed 31353194 ↗
• Bowen RL, Perry G, Xiong C, Smith MA, Atwood CS. A clinical study of lupron depot in the treatment of women with Alzheimer's disease: preservation of cognitive function in patients taking an acetylcholinesterase inhibitor and treated with high dose lupron over 48 weeks. J Alzheimers Dis. 2015;44(2):549-60. doi: 10.3233/JAD-141626. PubMed 25310993 ↗
• Ludvigsson JF, Adolfsson J, Hoistad M, Rydelius PA, Kristrom B, Landen M. A systematic review of hormone treatment for children with gender dysphoria and recommendations for research. Acta Paediatr. 2023 Nov;112(11):2279-2292. doi: 10.1111/apa.16791. Epub 2023 May 1. PubMed 37069492 ↗
• Glaser R, York AE, Dimitrakakis C. Beneficial effects of testosterone therapy in women measured by the validated Menopause Rating Scale (MRS). Maturitas. 2011 Apr;68(4):355-61. doi: 10.1016/j.maturitas.2010.12.001. Epub 2010 Dec 21. PubMed 21177051 ↗
• Chidi-Ogbolu N, Baar K. Effect of Estrogen on Musculoskeletal Performance and Injury Risk. Front Physiol. 2019 Jan 15;9:1834. doi: 10.3389/fphys.2018.01834. eCollection 2018. PubMed 30697162 ↗
• Greendale GA, Sternfeld B, Huang M, Han W, Karvonen-Gutierrez C, Ruppert K, Cauley JA, Finkelstein JS, Jiang SF, Karlamangla AS. Changes in body composition and weight during the menopause transition. JCI Insight. 2019 Mar 7;4(5):e124865. doi: 10.1172/jci.insight.124865. eCollection 2019 Mar 7. PubMed 30843880 ↗
• Juel Mortensen L, Kooij I, Lorenzen M, Rye Jorgensen N, Roder A, Jorgensen A, Andersson AM, Juul A, Blomberg Jensen M. Injection of luteinizing hormone or human chorionic gonadotropin increases calcium excretion and serum PTH in males. Cell Calcium. 2024 Sep;122:102908. doi: 10.1016/j.ceca.2024.102908. Epub 2024 May 24. PubMed 38852333 ↗
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Individual participant data

Plan to share: No