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CompletedNCT03933618CAPUpdated Nov 18, 2019Results posted

Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

A Phase 2 interventional study of Anastrozole 1mg and Clomiphene Citrate 25mg in Hypogonadism, Male, sponsored by Albany Medical College. Completed. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by Albany Medical College · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Apr 2015, registered Apr 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study summary

This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.

Read the detailed description

Aromatase inhibitors (AI) (Anastrazole) and selective estrogen receptor modifiers (SERMS)(clomiphene) increase testosterone production through stimulation of the hypothalamic pituitary axis. While these drugs both reduce the feedback inhibition of estrogen on the pituitary, SERMs cause an increase in serum estradiol, whereas AIs reduce estradiol levels. Using these medications, we can obtain therapeutic testosterone levels with either an increase or decrease in estradiol levels.

02

Conditions studied

  • Hypogonadism, Male

Browse trials for

03

In context

Eunuchism

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 55 interventional studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

Albany Medical College is the lead sponsor of 81 studies on the registry; 14 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Men age 18-70
  2. Baseline morning Testosterone 150-350 ng/dL x2
  3. leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
  4. Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
  5. (BMI) \<40
  6. Sexual health inventory for men (SHIM) score >7 and \<21. Patients are allowed to be taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline, however we will ask them to do the SHIM survey as if they were not taking this medication.
  7. Men must attempt to have at least four sexual encounters over each of the eight-week periods
  8. Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study

Exclusion criteria

Exclusion Criteria:

  1. Current or previous history of prostate cancer
  2. Previous or current androgen deprivation therapy for prostate cancer,
  3. Past surgical history of prostatectomy.
  4. History of testicular cancer.
  5. History of deep vein thrombosis (DVT) or blood dyscrasia
  6. History of breast cancer
  7. Men with past or current treatment for erectile dysfunction including MUSE (alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or men who are on phosphodiesterase inhibitors will be allowed to be in the study but must stop their use at the screening visit.
  8. Chronic opioid use
  9. Use of within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
  10. History of or current use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) dihydroepiandrosterone (DHEA), dihydroepiandrosterone sulfate (DHEAS) or any growth promoters i.e. growth hormone itself or analogs of growth hormone
  11. History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet, estrogens
  12. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
  13. Having started a new medication during the past three months which may interfere with the outcome measures of the study
  14. Polycythemia (HCT >52% )
  15. History of prostate specific antigen (PSA)> 4.0 ng/dl
  16. Hematocrit (HCT)\< 36 %
  17. Liver function tests greater than 2 times upper normal limits or history of abnormal electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the investigator.
  18. Previous hypogonadal treatment within last 3 months. -
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Other
    anastrazole-clomiphene-placebo

    anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks

    Drug: Anastrozole 1mg · Drug: Clomiphene Citrate 25mg · Drug: Placebo - Cap

  • Other
    anastrazole-placebo-clomiphene

    anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks

    Drug: Anastrozole 1mg · Drug: Clomiphene Citrate 25mg · Drug: Placebo - Cap

  • Other
    clomiphene-anastrazole-placebo

    clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks

    Drug: Anastrozole 1mg · Drug: Clomiphene Citrate 25mg · Drug: Placebo - Cap

  • Other
    clomiphene-placebo-anastrazole

    clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks

    Drug: Anastrozole 1mg · Drug: Clomiphene Citrate 25mg · Drug: Placebo - Cap

  • Other
    placebo-clomiphene-anastrazole

    placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks

    Drug: Anastrozole 1mg · Drug: Clomiphene Citrate 25mg · Drug: Placebo - Cap

  • Other
    placebo-anastrazole-clomiphene

    placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks

    Drug: Anastrozole 1mg · Drug: Clomiphene Citrate 25mg · Drug: Placebo - Cap

Interventions

06

What researchers measure

Primary outcomes

  1. IIEF (International Index of Erectile Function) Score - Screen

    15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

    Time frame: At baseline

  2. IIEF (International Index of Erectile Function) Score - Week 8

    15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

    Time frame: Week 8

  3. IIEF (International Index of Erectile Function) Score - Week 16

    15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

    Time frame: Week 16

  4. IIEF (International Index of Erectile Function) Score - Week 24

    15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

    Time frame: Week 24

Secondary outcomes

  1. Normalized Testosterone - Screen

    Normalized at \>350ng/dl

    Time frame: Baseline

  2. Normalized Testosterone - Week 8

    Normalized at \>350ng/dl

    Time frame: Week 8

  3. Normalized Testosterone - Week 16

    Normalized at \>350ng/dl

    Time frame: Week 16

  4. Normalized Testosterone - Week 24

    Normalized at \>350ng/dl

    Time frame: Week 24

  5. ADAM (Androgen Deficiency in the Aging Male) Score - Screen

    Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

    Time frame: Baseline

  6. ADAM (Androgen Deficiency in the Aging Male) Score - Week 8

    Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

    Time frame: Week 8

  7. ADAM (Androgen Deficiency in the Aging Male) Score - Week 16

    Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

    Time frame: Week 16

  8. ADAM (Androgen Deficiency in the Aging Male) Score - Week 24

    Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

    Time frame: Week 24

  9. EHS (Erectile Hardness Score) - Screen

    Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

    Time frame: Baseline

  10. EHS (Erectile Hardness Score) - Week 8

    Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

    Time frame: Week 8

  11. EHS (Erectile Hardness Score) - Week 16

    Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

    Time frame: Week 16

  12. EHS (Erectile Hardness Score) - Week 24

    Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

    Time frame: Week 24

  13. LH - Screen

    Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

    Time frame: Baseline

  14. LH - Week 8

    Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

    Time frame: Week 8

  15. LH - Week 16

    Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

    Time frame: Week 16

  16. LH - Week 24

    Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

    Time frame: Week 24

  17. FSH - Screen

    Lab Values for follicle stimulating hormone

    Time frame: Baseline

  18. FSH - Week 8

    Lab Values for follicle stimulating hormone

    Time frame: Week 8

  19. FSH - Week 16

    Lab Values for follicle stimulating hormone

    Time frame: Week 16

  20. FSH - Week 24

    Lab Values for follicle stimulating hormone

    Time frame: Week 24

  21. Free Testosterone - Screen

    Measure of Free Testosterone

    Time frame: Baseline

  22. Free Testosterone - Week 8

    Measure of Free Testosterone

    Time frame: Week 8

  23. Free Testosterone - Week 16

    Measure of Free Testosterone

    Time frame: Week 16

  24. Free Testosterone - Week 24

    Measure of Free Testosterone

    Time frame: Week 24

  25. Estradiol - Screen

    Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24

    Time frame: Baseline

  26. Estradiol - Week 8

    Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

    Time frame: Week 8

  27. Estradiol - Week 16

    Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

    Time frame: Week 16

  28. Estradiol - Week 24

    Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

    Time frame: Week 24

  29. SHBG - Screen

    Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

    Time frame: Baseline

  30. SHBG - Week 8

    Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

    Time frame: Week 8

  31. SHBG - Week 16

    Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

    Time frame: Week 16

  32. SHBG - Week 24

    Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

    Time frame: Week 24

  33. SEP #1-3 Cumulative - Screen

    Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

    Time frame: Baseline

  34. SEP #1-3 Cumulative - Week 8

    Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

    Time frame: Week 8

  35. SEP #1-3 Cumulative - Week 16

    Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

    Time frame: Week 16

  36. SEP #1-3 Cumulative - Week 24

    Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

    Time frame: Week 24

07

Results

Posted Nov 18, 2019

Participant flow

Men will be incentivized to come to each clinic appointment with $20 dollars at the end. If they complete the study they will be able to earn $100. Men will be incentivized to not use phosphodiesterase inhibitors throughout the study by giving them three 100mg tablets of Viagra per month of the study for a total of twelve 100 mg tablets.

Baseline
Participant flow — Baseline
MilestoneAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Started444444
Completed444444
Not completed000000
Baseline to Week 8
Participant flow — Baseline to Week 8
MilestoneAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Started444444
Completed444444
Not completed000000
Week 8 to Week 16
Participant flow — Week 8 to Week 16
MilestoneAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Started444444
Completed444444
Not completed000000
Week 16 to Week 24
Participant flow — Week 16 to Week 24
MilestoneAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Started444444
Completed444444
Not completed000000

Outcome measures

PrimaryIIEF (International Index of Erectile Function) Score - Screen

15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Time frame:
At baseline
Reported as:
Number · score on a scale
IIEF (International Index of Erectile Function) Score - Screen
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6344357415724
Patients 7-12575745323655
Patients 13-18554641455832
Patients 19-24505255471862
PrimaryIIEF (International Index of Erectile Function) Score - Week 8

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Time frame:
Week 8
Reported as:
Number · score on a scale
IIEF (International Index of Erectile Function) Score - Week 8
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6255532206635
Patients 7-12455163457237
Patients 13-18555932654328
Patients 19-24636570452553
PrimaryIIEF (International Index of Erectile Function) Score - Week 16

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Time frame:
Week 16
Reported as:
Number · score on a scale
IIEF (International Index of Erectile Function) Score - Week 16
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6455335456637
Patients 7-12435650553338
Patients 13-18536237585915
Patients 19-2462385147—18
PrimaryIIEF (International Index of Erectile Function) Score - Week 24

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Time frame:
Week 24
Reported as:
Number · score on a scale
IIEF (International Index of Erectile Function) Score - Week 24
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6127042526541
Patients 7-12546043352745
Patients 13-186065—724517
Patients 19-2452596047—14
SecondaryNormalized Testosterone - Screen

Normalized at \>350ng/dl

Time frame:
Baseline
Reported as:
Number · ng/dl
Normalized Testosterone - Screen
ng/dlAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6205330226367315321
Patients 7-12293237194300214243
Patients 13-18347328268206321148
Patients 19-2495291306244—289
SecondaryNormalized Testosterone - Week 8

Normalized at \>350ng/dl

Time frame:
Week 8
Reported as:
Number · ng/dl
Normalized Testosterone - Week 8
ng/dlAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-64847575661316133470
Patients 7-12387296693917271298
Patients 13-18607453216527270139
Patients 19-24545676592497—296
SecondaryNormalized Testosterone - Week 16

Normalized at \>350ng/dl

Time frame:
Week 16
Reported as:
Number · ng/dl
Normalized Testosterone - Week 16
ng/dlAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6437591338391696502
Patients 7-12337200451403396520
Patients 13-18329191124206585283
Patients 19-24609323456288—484
SecondaryNormalized Testosterone - Week 24

Normalized at \>350ng/dl

Time frame:
Week 24
Reported as:
Number · ng/dl
Normalized Testosterone - Week 24
ng/dlAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6268793214537412596
Patients 7-12269519440531375972
Patients 13-18446449—447487195
Patients 19-24196630274486——
SecondaryADAM (Androgen Deficiency in the Aging Male) Score - Screen

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Time frame:
Baseline
Reported as:
Number · score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Screen
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6111111
Patients 7-12111111
Patients 13-18111111
Patients 19-24111111
SecondaryADAM (Androgen Deficiency in the Aging Male) Score - Week 8

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Time frame:
Week 8
Reported as:
Number · score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6111111
Patients 7-12110101
Patients 13-18101001
Patients 19-24—11111
SecondaryADAM (Androgen Deficiency in the Aging Male) Score - Week 16

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Time frame:
Week 16
Reported as:
Number · score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6111101
Patients 7-12111111
Patients 13-18111001
Patients 19-241111—1
SecondaryADAM (Androgen Deficiency in the Aging Male) Score - Week 24

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Time frame:
Week 24
Reported as:
Number · score on a scale
ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6100101
Patients 7-12111111
Patients 13-1800——11
Patients 19-241110—1
SecondaryEHS (Erectile Hardness Score) - Screen

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Time frame:
Baseline
Reported as:
Number · score on a scale
EHS (Erectile Hardness Score) - Screen
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6333233
Patients 7-12333233
Patients 13-18333213
Patients 19-24333333
SecondaryEHS (Erectile Hardness Score) - Week 8

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Time frame:
Week 8
Reported as:
Number · score on a scale
EHS (Erectile Hardness Score) - Week 8
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6141131
Patients 7-12333242
Patients 13-18333313
Patients 19-24333213
SecondaryEHS (Erectile Hardness Score) - Week 16

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Time frame:
Week 16
Reported as:
Number · score on a scale
EHS (Erectile Hardness Score) - Week 16
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6332243
Patients 7-12333323
Patients 13-18343410
Patients 19-243133—1
SecondaryEHS (Erectile Hardness Score) - Week 24

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Time frame:
Week 24
Reported as:
Number · score on a scale
EHS (Erectile Hardness Score) - Week 24
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6342233
Patients 7-12333223
Patients 13-1834—411
Patients 19-243133—1
SecondaryLH - Screen

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Time frame:
Baseline
Reported as:
Number · IU/L
LH - Screen
IU/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-63.53.63.86.83.53.4
Patients 7-123.43.82.44.12.41.7
Patients 13-181.13.54.13.363.1
Patients 19-246.34.14.75.9—6.8
SecondaryLH - Week 8

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Time frame:
Week 8
Reported as:
Number · IU/L
LH - Week 8
IU/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-69.15.19.917.33.66.3
Patients 7-125.2410.712.63.31.9
Patients 13-182.96.96.14.76.73
Patients 19-244.211.57.56.9—7.3
SecondaryLH - Week 16

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Time frame:
Week 16
Reported as:
Number · IU/L
LH - Week 16
IU/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-66.84.64.25.413.98.9
Patients 7-126.94.86.34.95.23.8
Patients 13-181.92.12.21.9136.4
Patients 19-247.84.36.64.9—7.4
SecondaryLH - Week 24

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Time frame:
Week 24
Reported as:
Number · IU/L
LH - Week 24
IU/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-634.13.46.457.7
Patients 7-126.112.65.96.42.910.5
Patients 13-182.25.4—7.67.18.1
Patients 19-242.715.14.75.4——
SecondaryFSH - Screen

Lab Values for follicle stimulating hormone

Time frame:
Baseline
Reported as:
Number · IU/L
FSH - Screen
IU/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-62.72.45.54.53.33.6
Patients 7-125.73.73.92.91.83.5
Patients 13-181.65.11.744.45.7
Patients 19-245.5104.54.4—5.1
SecondaryFSH - Week 8

Lab Values for follicle stimulating hormone

Time frame:
Week 8
Reported as:
Number · IU/L
FSH - Week 8
IU/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-65.44.38.216.23.44.1
Patients 7-127.76.27.83.032.24.2
Patients 13-1838.31.86.34.76
Patients 19-2411.320.36.18.1—4.4
SecondaryFSH - Week 16

Lab Values for follicle stimulating hormone

Time frame:
Week 16
Reported as:
Number · IU/L
FSH - Week 16
IU/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-674.34.25.310.76.8
Patients 7-127.23.762.92.66.5
Patients 13-181.93.81.23.38.311.5
Patients 19-2412.811.46.24.2—8.9
SecondaryFSH - Week 24

Lab Values for follicle stimulating hormone

Time frame:
Week 24
Reported as:
Number · IU/L
FSH - Week 24
IU/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-64.14.835.26.54
Patients 7-124.415.163.75.214.5
Patients 13-1827.2—7.25.910.4
Patients 19-244.829.755.8——
SecondaryFree Testosterone - Screen

Measure of Free Testosterone

Time frame:
Baseline
Reported as:
Number · ng/dl
Free Testosterone - Screen
ng/dlAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-68.46.997.288.826.277.86
Patients 7-126.749.316.079.95.825.78
Patients 13-189.5612.27—4.869.49—
Patients 19-242.197.276.527.71—6.33
SecondaryFree Testosterone - Week 8

Measure of Free Testosterone

Time frame:
Week 8
Reported as:
Number · ng/dl
Free Testosterone - Week 8
ng/dlAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-619.4621.817.7235.272.7112.3
Patients 7-1215.63—19.3327.799.45.3
Patients 13-1821.6115.18—21.718.91—
Patients 19-2417.4420.0111.3715.71—6.04
SecondaryFree Testosterone - Week 16

Measure of Free Testosterone

Time frame:
Week 16
Reported as:
Number · ng/dl
Free Testosterone - Week 16
ng/dlAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-614.1616.3712.2712.6719.2117.47
Patients 7-128.835.714.79.6314.5713.47
Patients 13-1810.175.98—6.6316.387.58
Patients 19-2414.989.4611.22——11.62
SecondaryFree Testosterone - Week 24

Measure of Free Testosterone

Time frame:
Week 24
Reported as:
Number · ng/dl
Free Testosterone - Week 24
ng/dlAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-610.5119.356.2511.288.6519.31
Patients 7-126.11—11.0917.8911.6325.27
Patients 13-1811.8213.74—18.1915.49—
Patients 19-245.8213.546.1116.82——
SecondaryEstradiol - Screen

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24

Time frame:
Baseline
Reported as:
Number · pg/mL
Estradiol - Screen
pg/mLAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-621.68.19.613.515.918.4
Patients 7-12919.321.311.418.610.9
Patients 13-1813.320.116.214.115.913.1
Patients 19-249.515.526.611—26.8
SecondaryEstradiol - Week 8

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Time frame:
Week 8
Reported as:
Number · pg/mL
Estradiol - Week 8
pg/mLAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-611.2—49.894.520.822.5
Patients 7-12715.170.14518.59.3
Patients 13-189.74.925.133.51015.9
Patients 19-247.410.751.739.1—27.4
SecondaryEstradiol - Week 16

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Time frame:
Week 16
Reported as:
Number · pg/mL
Estradiol - Week 16
pg/mLAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-639.5—8.917.956.95
Patients 7-1213.121.612.814.428.26.8
Patients 13-1820.11523.813.1374.9
Patients 19-2448.528.314.815.9—4.9
SecondaryEstradiol - Week 24

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Time frame:
Week 24
Reported as:
Number · pg/mL
Estradiol - Week 24
pg/mLAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-622.543.916.29.518.141.1
Patients 7-1212.549.16.6511.685.9
Patients 13-1825.536.4—9.24.929.3
Patients 19-2422.239.4194.9——
SecondarySHBG - Screen

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Time frame:
Baseline
Reported as:
Number · nmol/L
SHBG - Screen
nmol/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-613.935.22031.726.224.1
Patients 7-1230.712.623.526.420.926.8
Patients 13-1823.517.521.42016.914.8
Patients 19-2428.62235.511.6—30.6
SecondarySHBG - Week 8

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Time frame:
Week 8
Reported as:
Number · nmol/L
SHBG - Week 8
nmol/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-61038.218.429.823.921.6
Patients 7-1223.412.72627.224.125.7
Patients 13-1826.916.121.630.914.317.6
Patients 19-2428.120.142.720.9—30.7
SecondarySHBG - Week 16

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Time frame:
Week 16
Reported as:
Number · nmol/L
SHBG - Week 16
nmol/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-622.335.513.816.433.317.7
Patients 7-1230.715.326.63116.723
Patients 13-1826.817.214.222.817.216.6
Patients 19-2439.324.83513.9—31
SecondarySHBG - Week 24

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Time frame:
Week 24
Reported as:
Number · nmol/L
SHBG - Week 24
nmol/LAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-614.641.815.125.229.723.6
Patients 7-1233.81624.425.313.834.1
Patients 13-182921.7—20.117.317.5
Patients 19-2423.22633.813.7——
SecondarySEP #1-3 Cumulative - Screen

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Time frame:
Baseline

No measurements were reported for this outcome.

SecondarySEP #1-3 Cumulative - Week 8

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Time frame:
Week 8
Reported as:
Number · score on a scale
SEP #1-3 Cumulative - Week 8
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6331134
Patients 7-122322—3
Patients 13-18—2—1—2
Patients 19-24333—12
SecondarySEP #1-3 Cumulative - Week 16

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Time frame:
Week 16
Reported as:
Number · score on a scale
SEP #1-3 Cumulative - Week 16
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-623—1—2
Patients 7-123333—0
Patients 13-1843—332
Patients 19-243333—1
SecondarySEP #1-3 Cumulative - Week 24

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Time frame:
Week 24
Reported as:
Number · score on a scale
SEP #1-3 Cumulative - Week 24
score on a scaleAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Patients 1-6—3—332
Patients 7-123331—0
Patients 13-18—3—202
Patients 19-24333——1

Adverse events

Collected over Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Anastrazole-clomiphene-placebo0/4 (0%)0/4 (0%)2/4 (50%)
Anastrazole-placebo-clomiphene0/4 (0%)0/4 (0%)1/4 (25%)
Clomiphene-anastrazole-placebo0/4 (0%)0/4 (0%)1/4 (25%)
Clomiphene-placebo-anastrazole0/4 (0%)0/4 (0%)1/4 (25%)
Placebo-clomiphene-anastrazole0/4 (0%)1/4 (25%)1/4 (25%)
Placebo-anastrazole-clomiphene0/4 (0%)0/4 (0%)3/4 (75%)
Most frequent serious events
Most frequent serious events
EventAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
Lyme DiseaseInfections and infestations0/40/40/40/41/40/4
Most frequent other events
Showing 10 of 16
Most frequent other events
EventAnastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomiphene
HeadacheGeneral disorders0/41/40/40/41/40/4
OsteopeniaMusculoskeletal and connective tissue disorders1/40/40/40/40/40/4
Rib PainMusculoskeletal and connective tissue disorders1/40/40/40/40/40/4
Nasal Septal DeviationGeneral disorders0/40/41/40/40/40/4
Left Shoulder PainMusculoskeletal and connective tissue disorders0/40/40/40/40/41/4
Upper Respiratory Infection (URI)Infections and infestations0/40/40/41/40/40/4
Vitamin D deficiencyEndocrine disorders0/40/40/40/40/41/4
DizzinessNervous system disorders0/40/40/40/40/41/4
InsomniaGeneral disorders1/40/40/40/41/40/4
FatigueGeneral disorders1/40/40/40/40/41/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Anastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomipheneTotal
<=18 years0000000
Between 18 and 65 years44444424
>=65 years0000000
Sex: Female, Male
Sex: Female, Male(Participants)Anastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomipheneTotal
Female0000000
Male44444424
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Anastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomipheneTotal
Hispanic or Latino0001001
Not Hispanic or Latino44434423
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)Anastrazole-clomiphene-placeboAnastrazole-placebo-clomipheneClomiphene-anastrazole-placeboClomiphene-placebo-anastrazolePlacebo-clomiphene-anastrazolePlacebo-anastrazole-clomipheneTotal
United States4444444
08

Study locations

No study locations are listed for this record.

09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03933618
Lead sponsor
Albany Medical College
Collaborators
Laboratory Corporation of America
Responsible party
Sponsor
First posted
May 1, 2019
Start date
Apr 2, 2015
Primary completion
Mar 8, 2017
Completion
Mar 8, 2017
Results posted
Nov 18, 2019
Last update
Nov 18, 2019

Study contacts

Robert C Welliver, MD
principal investigator · Albany Medical College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Anastrozole · Clomiphene

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