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Completed

NCT Number: NCT03749109

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

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.

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Key information

Conditions

Endometriosis Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gyneacology Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
  • Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
  • Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
  • 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
  • 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)
  • 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

  • Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
  • Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
  • 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.
  • Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
  • Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)

Treatment and study plan

Quinagolide 1080 µg

Drug

Vaginal ring containing Quinagolide 1080 µg for daily releases

Other names: FE 999051

Placebo

Drug

Matching placebo

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

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

    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.

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  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

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

    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.

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

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

    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

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

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

    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.

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

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

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

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

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

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

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

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

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

    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)

    Assessed by blood sample collection

  16. Changes in Clinical Chemistry and Hematology Parameters: Hematocrit

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

    Assessed by blood sample collection

  17. Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

  21. Changes in Clinical Chemistry and Hematology Parameters: Platelets

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

    Assessed by blood sample collection

  22. Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes

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

    Assessed by blood sample collection

  23. Changes in Clinical Chemistry and Hematology Parameters: Leukocytes

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

  25. Changes in Clinical Chemistry and Hematology Parameters: Albumin

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

  28. Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

  30. Changes in Clinical Chemistry and Hematology Parameters: Bilirubin

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

    Assessed by blood sample collection

  31. Changes in Clinical Chemistry and Hematology Parameters: Calcium

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

    Assessed by blood sample collection

  32. Changes in Clinical Chemistry and Hematology Parameters: Chloride

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

    Assessed by blood sample collection

  33. Changes in Clinical Chemistry and Hematology Parameters: Cholesterol

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

    Assessed by blood sample collection

  34. Changes in Clinical Chemistry and Hematology Parameters: Creatinine

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

  36. Changes in Clinical Chemistry and Hematology Parameters: Glucose

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

  38. Changes in Clinical Chemistry and Hematology Parameters: Phosphate

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

    Assessed by blood sample collection

  39. Changes in Clinical Chemistry and Hematology Parameters: Potassium

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

    Assessed by blood sample collection

  40. Changes in Clinical Chemistry and Hematology Parameters: Sodium

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

    Assessed by blood sample collection

  41. Changes in Clinical Chemistry and Hematology Parameters: Protein

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

    Assessed by blood sample collection

  42. Changes in Clinical Chemistry and Hematology Parameters: Urate

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

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

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

    Assessed by blood sample collection

  45. Frequency and Intensity of Adverse Events

    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)

    Assessed by and Adverse Event Log completed by the Investigator

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Randomised, 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

Acronym: QLARITY

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 21, 2018
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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