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CompletedNCT03749109QLARITYUpdated Aug 7, 2023Results posted

Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis

A Phase 2 interventional study of Quinagolide 1080 µg and Placebo in Endometriosis, sponsored by Ferring Pharmaceuticals. Completed at 11 sites in 4 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by Ferring Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.

02

Conditions studied

  • Endometriosis

Keywords

  • Endometrioma
  • Adenomyosis
  • Deep infiltrating endometriosis
03

In context

Endometriosis

925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.

This study's enrollment of 67 is close to the median of 65 across 539 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.

Browse Ferring Pharmaceuticals studies →

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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. Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
  2. Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
  3. Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
  4. Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary
  5. Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use)
  6. Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomization to the end of treatment

Exclusion criteria

Exclusion Criteria:

  1. Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
  2. Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
  3. Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit.
  4. Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
  5. Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Quinagolide 1080 µg

    Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.

    Drug: Quinagolide 1080 µg

  • Placebo comparator
    Placebo

    Vaginal ring containing matching placebo

    Drug: Placebo

Interventions

  • DrugQuinagolide 1080 µg

    Vaginal ring containing Quinagolide 1080 µg for daily releases

    Also known as: FE 999051

  • DrugPlacebo

    Matching placebo

06

What researchers measure

Primary outcomes

  1. Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4

    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

Secondary outcomes

  1. Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4

    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  2. Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4

    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  3. Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4

    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  4. Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4

    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  5. Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4

    The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  6. Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4

    Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

  7. Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4

    B\&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15.

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

  8. Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4

    Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes: * during the last menstrual cycle * during the menstrual period of the last menstrual cycle * during the non-menstrual period of the last menstrual cycle

    Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)

  9. Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4

    EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.

    Time frame: At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)

  10. Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)

    Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.

    Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)

  11. Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)

    Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.

    Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)

  12. Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4

    Assessed by blood sample collection

    Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)

  13. Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4

    Assessed by blood sample collection

    Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)

  14. Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4

    Assessed by blood sample collection

    Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)

  15. Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4

    Assessed by blood sample collection

    Time frame: Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)

  16. Changes in Clinical Chemistry and Hematology Parameters: Hematocrit

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  17. Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  18. Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  19. Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  20. Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  21. Changes in Clinical Chemistry and Hematology Parameters: Platelets

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  22. Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  23. Changes in Clinical Chemistry and Hematology Parameters: Leukocytes

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  24. Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  25. Changes in Clinical Chemistry and Hematology Parameters: Albumin

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  26. Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  27. Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  28. Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  29. Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  30. Changes in Clinical Chemistry and Hematology Parameters: Bilirubin

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  31. Changes in Clinical Chemistry and Hematology Parameters: Calcium

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  32. Changes in Clinical Chemistry and Hematology Parameters: Chloride

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  33. Changes in Clinical Chemistry and Hematology Parameters: Cholesterol

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  34. Changes in Clinical Chemistry and Hematology Parameters: Creatinine

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  35. Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  36. Changes in Clinical Chemistry and Hematology Parameters: Glucose

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  37. Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  38. Changes in Clinical Chemistry and Hematology Parameters: Phosphate

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  39. Changes in Clinical Chemistry and Hematology Parameters: Potassium

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  40. Changes in Clinical Chemistry and Hematology Parameters: Sodium

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  41. Changes in Clinical Chemistry and Hematology Parameters: Protein

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  42. Changes in Clinical Chemistry and Hematology Parameters: Urate

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  43. Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  44. Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters

    Assessed by blood sample collection

    Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

  45. Frequency and Intensity of Adverse Events

    Assessed by and Adverse Event Log completed by the Investigator

    Time frame: From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)

07

Results

Posted Sep 7, 2022

Participant flow

The trial was performed in 6 investigational sites in 3 countries between Aug 2019 to Jul 2021.

Participant flow — Overall Study
MilestoneQuinagolide 1080 µgPlacebo
Started3532
Completed3332
Not completed20
Withdrew: Adverse event20

Outcome measures

PrimaryChanges in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4

The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Least squares mean · mm
Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4
mmQuinagolide 1080 µgPlacebo
Endometrioma-0.20 ± 4.34-1.94 ± 4.48
DIE2.41 ± 2.52-0.94 ± 2.03
Adenomyosis-3.10 ± 3.75-3.43 ± 3.87
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.78 · Difference in ls mean: 1.74 · 95% CI -10.45 to 13.94ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.29 · Difference in ls mean: 3.35 · 95% CI -2.89 to 9.59ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.95 · Difference in ls mean: 0.33 · 95% CI -10.33 to 10.99ANCOVA adjusted for baseline lesion size.
SecondaryPercentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4

The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · Percentage of changes in the size
Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
Percentage of changes in the sizeQuinagolide 1080 µgPlacebo
Endometrioma15.64 ± 70.12-6.83 ± 44.46
DIE7.67 ± 15.225.81 ± 37.73
Adenomyosis-3.04 ± 32.31-6.99 ± 25.48
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.65 · Difference in ls mean: -6.99 · 95% CI -36.80 to 22.82ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.92 · Difference in ls mean: -1.13 · 95% CI -22.77 to 20.51ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.74 · Difference in ls mean: -5.92 · 95% CI -40.94 to 29.10ANCOVA adjusted for baseline lesion size.
SecondaryProportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4

The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Number · Percentage of lesions
Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4
Percentage of lesionsQuinagolide 1080 µgPlacebo
Endometrioma18.921.7
DIE012.1
Adenomyosis12.124.1
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · Regression, Logistic · p = 0.95 · Odds ratio (or): 1.04 · 95% CI 0.38 to 2.82
  • Quinagolide 1080 µg vs Placebo · Regression, Logistic · p = 0.39 · Odds ratio (or): 0.55 · 95% CI 0.14 to 2.17
SecondaryProportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4

The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Number · Percentage of subjects
Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4
Percentage of subjectsQuinagolide 1080 µgPlacebo
Endometrioma24.031.8
DIE011.5
Adenomyosis15.037.5
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · Regression, Logistic · p = 0.60 · Odds ratio (or): 0.70 · 95% CI 0.19 to 2.65
  • Quinagolide 1080 µg vs Placebo · Regression, Logistic · p = 0.21 · Odds ratio (or): 0.35 · 95% CI 0.07 to 1.79
SecondaryNumber of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4

The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Number · Lesions
Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
LesionsQuinagolide 1080 µgPlacebo
Endometrioma - Disappearing Lesions145
DIE - Disappearing Lesions01
Adenomyosis - Disappearing Lesions12
Endometrioma - New Lesions33
DIE - New Lesions00
Adenomyosis - New Lesions00
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · Negative-binomial regression · p = 0.13 · Rate ratio: 2.53 · 95% CI 0.76 to 8.39
  • Quinagolide 1080 µg vs Placebo · Negative-binomial regression · p = 0.56 · Rate ratio: 0.49 · 95% CI 0.04 to 5.41
SecondaryChanges in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4

The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Least squares mean · mm^3
Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4
mm^3Quinagolide 1080 µgPlacebo
Endometrioma2.12 ± 4.621.89 ± 4.77
DIE-0.15 ± 1.81-0.87 ± 1.25
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.97 · Difference in ls mean: 0.23 · 95% CI -12.78 to 13.23ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.74 · Difference in ls mean: 0.72 · 95% CI -3.63 to 5.07ANCOVA adjusted for baseline lesion size.
SecondaryChanges in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4

Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.

Time frame:
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Reported as:
Least squares mean · mm
Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
mmQuinagolide 1080 µgPlacebo
Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 414.19 ± 8.704.06 ± 9.02
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.42 · Difference in ls mean: 10.13 · 95% CI -14.74 to 35.00ANCOVA adjusted for baseline lesion size.
SecondaryChanges in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4

B\&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15.

Time frame:
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Reported as:
Mean · score on a scale
Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
score on a scaleQuinagolide 1080 µgPlacebo
Endometrioma-1.2 ± 2.26-2.1 ± 2.51
DIE-1.3 ± 2.16-1.6 ± 2.21
Adenomyosis-1.5 ± 2.33-1.9 ± 1.86
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.10 · Difference in ls mean: 1.09 · 95% CI -0.20 to 2.38ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.67 · Difference in ls mean: 0.28 · 95% CI -1.02 to 1.58ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.64 · Difference in ls mean: 0.32 · 95% CI -1.06 to 1.71ANCOVA adjusted for baseline lesion size.
SecondaryChanges in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4

Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes: * during the last menstrual cycle * during the menstrual period of the last menstrual cycle * during the non-menstrual period of the last menstrual cycle

Time frame:
At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Reported as:
Mean · score on a scale
Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
score on a scaleQuinagolide 1080 µgPlacebo
Endometrioma at cycle 1-0.5 ± 1.96-0.7 ± 2.21
Endometrioma at cycle 2-0.9 ± 2.17-1.1 ± 2.85
Endometrioma at cycle 3-1.7 ± 2.73-1.1 ± 1.67
Endometrioma at cycle 4-1.5 ± 3.11-2.0 ± 1.94
DIE at cycle 1-0.6 ± 2.14-0.7 ± 2.19
DIE at cycle 2-1.1 ± 2.20-1.4 ± 2.97
DIE at cycle 3-1.7 ± 2.65-1.0 ± 1.97
DIE at cycle 4-1.2 ± 2.27-2.1 ± 2.21
Adenomyosis at cycle 10.3 ± 1.84-0.7 ± 2.24
Adenomyosis at cycle 2-0.7 ± 2.37-0.9 ± 2.13
Adenomyosis at cycle 3-0.8 ± 2.34-0.9 ± 1.78
Adenomyosis at cycle 4-1.6 ± 2.91-1.9 ± 2.28
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.73 · Difference in ls mean: 0.21 · 95% CI -1.02 to 1.44ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.54 · Difference in ls mean: 0.42 · 95% CI -0.97 to 1.82ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.46 · Difference in ls mean: -0.50 · 95% CI -1.86 to 0.85ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.49 · Difference in ls mean: 0.53 · 95% CI -0.99 to 2.05ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.99 · Difference in ls mean: -0.01 · 95% CI -1.32 to 1.30ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.83 · Difference in ls mean: 0.17 · 95% CI -1.38 to 1.71ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.28 · Difference in ls mean: -0.74 · 95% CI -2.11 to 0.63ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.26 · Difference in ls mean: 0.75 · 95% CI -0.57 to 2.07ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.19 · Difference in ls mean: 0.91 · 95% CI -0.49 to 2.31ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.93 · Difference in ls mean: 0.07 · 95% CI -1.45 to 1.58ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.85 · Difference in ls mean: -0.13 · 95% CI -1.58 to 1.32ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.99 · Difference in ls mean: 0.01 · 95% CI -1.68 to 1.69ANCOVA adjusted for baseline lesion size.
SecondaryChanges in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4

EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.

Time frame:
At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)
Reported as:
Mean · Score on a scale
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
Score on a scaleQuinagolide 1080 µgPlacebo
Endometrioma at cycle 2-46.6 ± 90.49-51.0 ± 71.60
Endometrioma at cycle 4-56.6 ± 88.84-94.0 ± 85.14
DIE at cycle 2-55.6 ± 91.14-41.7 ± 86.27
DIE at cycle 4-54.8 ± 87.29-85.7 ± 98.96
Adenomyosis at cycle 2-46.3 ± 102.92-33.2 ± 52.21
Adenomyosis at cycle 4-64.9 ± 105.62-79.4 ± 90.04
Statistical analysis
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.75 · Difference in ls mean: -7.35 · 95% CI -53.97 to 39.27ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.42 · Difference in ls mean: 17.31 · 95% CI -25.41 to 60.04ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.47 · Difference in ls mean: -17.66 · 95% CI -66.30 to 30.98ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.27 · Difference in ls mean: 25.61 · 95% CI -21.05 to 72.27ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.41 · Difference in ls mean: -20.95 · 95% CI -71.83 to 29.92ANCOVA adjusted for baseline lesion size.
  • Quinagolide 1080 µg vs Placebo · ANCOVA · p = 0.93 · Difference in ls mean: 2.25 · 95% CI -49.57 to 54.06ANCOVA adjusted for baseline lesion size.
SecondaryChanges in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)

Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.

Time frame:
At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Reported as:
Mean · Days
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)
DaysQuinagolide 1080 µgPlacebo
Endometrioma at baseline31.9 ± 10.5432.6 ± 10.38
Endometrioma at cycle 127.8 ± 2.9226.9 ± 2.39
Endometrioma at cycle 228.1 ± 2.1327.4 ± 2.50
Endometrioma at cycle 327.7 ± 2.1228.3 ± 2.65
Endometrioma at cycle 428.2 ± 3.2726.9 ± 2.23
DIE at baseline33.2 ± 11.8031.4 ± 9.45
DIE at cycle 126.7 ± 2.6627.3 ± 2.78
DIE at cycle 227.4 ± 1.9827.7 ± 2.52
DIE at cycle 328.2 ± 2.8628.5 ± 2.29
DIE at cycle 426.9 ± 2.2327.7 ± 2.59
Adenomyosis at baseline33.5 ± 11.1632.4 ± 11.49
Adenomyosis at cycle 127.7 ± 2.5426.8 ± 2.61
Adenomyosis at cycle 228.3 ± 2.2327.4 ± 2.37
Adenomyosis at cycle 327.8 ± 2.5227.9 ± 1.93
Adenomyosis at cycle 427.2 ± 1.5027.4 ± 1.87
SecondaryChanges in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)

Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.

Time frame:
At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Reported as:
Mean · Days
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)
DaysQuinagolide 1080 µgPlacebo
Endometrioma at baseline5.1 ± 1.085.1 ± 0.97
Endometrioma at cycle 15.3 ± 1.714.7 ± 0.77
Endometrioma at cycle 25.3 ± 1.225.1 ± 0.87
Endometrioma at cycle 34.5 ± 1.614.8 ± 0.89
Endometrioma at cycle 45.0 ± 1.434.7 ± 1.52
DIE at baseline4.9 ± 0.995.3 ± 1.01
DIE at cycle 15.0 ± 1.604.6 ± 0.70
DIE at cycle 25.0 ± 1.825.0 ± 1.04
DIE at cycle 34.5 ± 1.224.9 ± 0.93
DIE at cycle 45.2 ± 1.044.9 ± 1.60
Adenomyosis at baseline5.2 ± 1.205.4 ± 1.15
Adenomyosis at cycle 15.0 ± 1.754.9 ± 0.62
Adenomyosis at cycle 24.6 ± 1.784.8 ± 1.17
Adenomyosis at cycle 34.3 ± 1.664.7 ± 1.05
Adenomyosis at cycle 45.0 ± 0.745.0 ± 1.32
SecondarySerum Levels of Prolactin During Cycle 1, at Cycles 2 and 4

Assessed by blood sample collection

Time frame:
Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Reported as:
Mean · pg/L
Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
pg/LQuinagolide 1080 µgPlacebo
Endometrioma at cycle 15.51 ± 3.60412.68 ± 4.618
Endometrioma at cycle 29.30 ± 4.73912.79 ± 4.381
Endometrioma at cycle 49.47 ± 4.08112.31 ± 6.648
DIE at cycle 15.95 ± 3.25810.80 ± 4.201
DIE at cycle 210.36 ± 5.11811.85 ± 5.029
DIE at cycle 410.65 ± 4.46512.08 ± 6.739
Adenomyosis at cycle 15.80 ± 4.01712.13 ± 4.563
Adenomyosis at cycle 27.97 ± 2.60811.94 ± 4.150
Adenomyosis at cycle 49.35 ± 3.41811.95 ± 4.395
SecondarySerum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4

Assessed by blood sample collection

Time frame:
Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Reported as:
Mean · mIU/L
Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
mIU/LQuinagolide 1080 µgPlacebo
Endometrioma at cycle 11.672 ± 1.33761.513 ± 0.6822
Endometrioma at cycle 21.785 ± 1.05351.509 ± 0.6746
Endometrioma at cycle 41.692 ± 0.94891.422 ± 0.6528
DIE at cycle 11.706 ± 1.55501.394 ± 0.8200
DIE at cycle 21.726 ± 1.16331.383 ± 0.6903
DIE at cycle 41.375 ± 0.89531.299 ± 0.6571
Adenomyosis at cycle 12.067 ± 1.81001.325 ± 0.7248
Adenomyosis at cycle 21.722 ± 1.15571.311 ± 0.5664
Adenomyosis at cycle 41.801 ± 0.94631.353 ± 0.5614
SecondarySerum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4

Assessed by blood sample collection

Time frame:
Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Reported as:
Mean · nmol/L
Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
nmol/LQuinagolide 1080 µgPlacebo
Endometrioma at cycle 123.90 ± 8.00222.96 ± 6.721
Endometrioma at cycle 219.9 ± 6.51121.81 ± 5.481
Endometrioma at cycle 421.82 ± 5.45020.22 ± 5.786
DIE at cycle 122.16 ± 8.09923.68 ± 6.135
DIE at cycle 218.01 ± 5.48421.07 ± 6.526
DIE at cycle 420.98 ± 5.67820.53 ± 6.083
Adenomyosis at cycle 121.80 ± 7.76322.51 ± 4.580
Adenomyosis at cycle 219.17 ± 6.49719.93 ± 5.233
Adenomyosis at cycle 421.19 ± 6.33118.93 ± 4.836
SecondaryPlasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4

Assessed by blood sample collection

Time frame:
Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Reported as:
Mean · pg/mL
Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4
pg/mLQuinagolide 1080 μg
Within 1-5 days of randomization11.66 ± 5.23
Within 7-14 days of randomization5.50 ± 2.59
Cycle 12.90 ± 1.33
Cycle 22.92 ± 1.68
Cycle 32.78 ± 1.32
Cycle 43.16 ± 3.03
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Hematocrit

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · % v/v
Changes in Clinical Chemistry and Hematology Parameters: Hematocrit
% v/vQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Hematocrit-0.007 ± 0.0181-0.005 ± 0.0259
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Hemaglobin

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · g/L
Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin
g/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin-3.6 ± 5.60-3.2 ± 8.69
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · pg/cell
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin
pg/cellQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin-0.7 ± 0.71-0.6 ± 1.22
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · g/L
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration
g/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration-3.1 ± 7.11-4.3 ± 8.76
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · fL
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume
fLQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume-1.2 ± 2.11-0.7 ± 3.10
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Platelets

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · 10^9 cells/L
Changes in Clinical Chemistry and Hematology Parameters: Platelets
10^9 cells/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Platelets4.9 ± 33.9811.6 ± 45.92
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Erythrocytes

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · 10^12 cells/L
Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes
10^12 cells/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes-0.02 ± 0.192-0.01 ± 0.228
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Leukocytes

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · 10^9 cells/L
Changes in Clinical Chemistry and Hematology Parameters: Leukocytes
10^9 cells/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Leukocytes-0.43 ± 1.9280.18 ± 2.055
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · U/L
Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase
U/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase-1.1 ± 5.88-0.2 ± 3.86
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Albumin

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · g/L
Changes in Clinical Chemistry and Hematology Parameters: Albumin
g/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Albumin0.0 ± 2.280.7 ± 2.84
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · IU/L
Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase
IU/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase3.1 ± 8.184.2 ± 6.67
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · U/L
Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase
U/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase1.0 ± 3.720.5 ± 3.43
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Bicarbonate

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate-2.7 ± 2.59-2.9 ± 2.51
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Direct Bilirubin

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · umol/L
Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin
umol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin0.0 ± 0.380.0 ± 1.10
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Bilirubin

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · umol/L
Changes in Clinical Chemistry and Hematology Parameters: Bilirubin
umol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Bilirubin-1.2 ± 2.84-0.8 ± 4.57
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Calcium

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Calcium
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Calcium0.009 ± 0.08960.012 ± 0.0773
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Chloride

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Chloride
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Chloride0.2 ± 2.68-0.5 ± 2.49
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Cholesterol

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Cholesterol
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Cholesterol0.045 ± 0.50500.244 ± 0.5219
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Creatinine

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · umol/L
Changes in Clinical Chemistry and Hematology Parameters: Creatinine
umol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Creatinine-3.5 ± 8.21-4.3 ± 7.82
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · U/L
Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase
U/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase-1.1 ± 4.771.0 ± 4.46
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Glucose

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Glucose
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Glucose-0.07 ± 0.734-0.06 ± 0.866
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · U/L
Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase
U/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase2.7 ± 12.302.8 ± 8.42
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Phosphate

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Phosphate
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Phosphate-0.013 ± 0.14520.048 ± 0.1885
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Potassium

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Potassium
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Potassium0.07 ± 0.3330.06 ± 0.357
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Sodium

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Sodium
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Sodium0.7 ± 2.040.4 ± 2.54
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Protein

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · g/L
Changes in Clinical Chemistry and Hematology Parameters: Protein
g/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Protein-0.1 ± 3.821.4 ± 3.19
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Urate

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · umol/L
Changes in Clinical Chemistry and Hematology Parameters: Urate
umol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Urate10.7 ± 56.361.3 ± 37.59
SecondaryChanges in Clinical Chemistry and Hematology Parameters: Urea Nitrogen

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Mean · mmol/L
Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen
mmol/LQuinagolide 1080 µgPlacebo
Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen-0.180 ± 1.01840.148 ± 1.2286
SecondaryProportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters

Assessed by blood sample collection

Time frame:
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Reported as:
Number · Percentage of subjects
Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters
Percentage of subjectsQuinagolide 1080 µgPlacebo
Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters2.860
SecondaryFrequency and Intensity of Adverse Events

Assessed by and Adverse Event Log completed by the Investigator

Time frame:
From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)
Reported as:
Number · Percentage of subjects
Frequency and Intensity of Adverse Events
Percentage of subjectsQuinagolide 1080 µgPlacebo
Mild adverse events28.643.8
Moderate adverse events42.937.5
Severe adverse events2.99.4

Adverse events

Collected over Adverse events were recorded for each participant from the time of signed informed consent for participation in the trial to follow-up visit (approximately 1 month after visit 8 (month 4), up to 5 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Quinagolide 1080 µg0/35 (0%)1/35 (2.9%)20/35 (57.1%)
Placebo0/32 (0%)0/32 (0%)20/32 (62.5%)
Most frequent serious events
Most frequent serious events
EventQuinagolide 1080 µgPlacebo
DyspnoeaRespiratory, thoracic and mediastinal disorders1/350/32
Most frequent other events
Showing 10 of 15
Most frequent other events
EventQuinagolide 1080 µgPlacebo
HeadacheNervous system disorders6/358/32
DizzinessNervous system disorders1/354/32
NauseaGastrointestinal disorders3/352/32
Rectal HaemorrhageGastrointestinal disorders0/352/32
FatigueGeneral disorders1/352/32
Corona virus infectionInfections and infestations0/352/32
HypoaesthesiaNervous system disorders0/352/32
Abdominal distensionGastrointestinal disorders2/351/32
Peripheral swellingGeneral disorders2/351/32
PyrexiaGeneral disorders2/350/32

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Quinagolide 1080 µgPlaceboTotal
<=18 years000
Between 18 and 65 years353267
>=65 years000
Age, Continuous
Age, Continuous(years)Quinagolide 1080 µgPlaceboTotal
Mean36.9 ± 5.5135.2 ± 5.9636.1 ± 5.75
Sex: Female, Male
Sex: Female, Male(Participants)Quinagolide 1080 µgPlaceboTotal
Female353267
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Quinagolide 1080 µgPlaceboTotal
Hispanic or Latino000
Not Hispanic or Latino353267
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Quinagolide 1080 µgPlaceboTotal
American Indian or Alaska Native101
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White343266
More than one race000
Unknown or Not Reported000
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Quinagolide 1080 µgPlaceboTotal
Mean23.91 ± 3.8623.30 ± 4.1523.62 ± 3.98
08

Study locations

11 sites
  • Gyneacology Rigshospitalet
    Copenhagen, Denmark
  • Charité Universitätsmedizin
    Berlin, Germany
  • Universitätsklinikum Carl Gustav Carus
    Dresden, Germany
  • Universitätsklinikum Münster
    Münster, Germany
  • Azienda Opsedaliera Universitaria Careggi
    Florence, Italy
  • Università degli Studi di Roma La Sapienza
    Rome, Italy
  • Azienda Ospedaliera Universitaria Senese
    Siena, Italy
  • Azienda Ospedaliera Universitaria Integrata Verona
    Verona, Italy
  • Centrum Medyczne PROMED
    Krakow, Poland
  • Gabinet Lekarski Specjalistyczny SONUS
    Warsaw, Poland
  • Specjalistyczny Gabinet Lekarski
    Warsaw, Poland
09

References and documents

Publications

  • Pellicer A, Taylor HS, Alberich-Bayarri A, Liu Y, Gamborg M, Barletta KE, Pinton P, Heiser PW, Bagger YZ. Quinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jun;310:113946. doi: 10.1016/j.ejogrb.2025.113946. Epub 2025 Mar 30. PubMed 40188683 ↗

Study documents

  • Study protocol · Nov 12, 2019
  • Statistical analysis plan · Aug 26, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03749109
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 21, 2018
Start date
Aug 19, 2019
Primary completion
Jun 21, 2021
Completion
Jul 18, 2021
Results posted
Sep 7, 2022
Last update
Aug 7, 2023

Study contacts

Global Clinical Compliance
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Quinagolide

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