We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749109
Recruitment Status : Completed
First Posted : November 21, 2018
Results First Posted : September 7, 2022
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Quinagolide 1080 µg Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 19, 2019
Actual Primary Completion Date : June 21, 2021
Actual Study Completion Date : July 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Quinagolide 1080 µg
Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.
Drug: Quinagolide 1080 µg
Vaginal ring containing Quinagolide 1080 µg for daily releases
Other Name: FE 999051

Placebo Comparator: Placebo
Vaginal ring containing matching placebo
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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:

  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749109


Locations
Layout table for location information
Denmark
Gyneacology Rigshospitalet
Copenhagen, Denmark
Germany
Charité Universitätsmedizin
Berlin, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Universitätsklinikum Münster
Münster, Germany
Italy
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
Poland
Centrum Medyczne PROMED
Kraków, Poland
Gabinet Lekarski Specjalistyczny SONUS
Warsaw, Poland
Specjalistyczny Gabinet Lekarski
Warsaw, Poland
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Global Clinical Compliance Ferring Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Ferring Pharmaceuticals:
Study Protocol  [PDF] November 12, 2019
Statistical Analysis Plan  [PDF] August 26, 2021

Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03749109    
Other Study ID Numbers: 000295
First Posted: November 21, 2018    Key Record Dates
Results First Posted: September 7, 2022
Last Update Posted: September 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ferring Pharmaceuticals:
Endometrioma
Adenomyosis
Deep infiltrating endometriosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis
Adenomyosis
Uterine Diseases
Quinagolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs