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

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ClinicalTrials.gov Identifier: NCT03749109
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
This will be 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 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 : June 21, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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) ]

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) ]
  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) ]
  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) ]
  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) ]
  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) ]
  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) ]
  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 4-point scale with 0=none and 3=severe.

  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 participants. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain

  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

  10. Changes in the menstrual bleeding pattern over 4 cycles [ Time Frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) ]
    Assessed by patient self-reported answers to menstrual bleeding questions

  11. Serum levels of prolactin, thyroid-stimulating hormone (TSH), insulin-like growth factor-1 (IGF-1) during cycle 1, at cycles 2 and 4 [ Time Frame: Within 1-5 days post randomisation, and at menstrual cycles 2 (~2 months) and 4 (~4 months) ]
    Assessed by blood sample collection

  12. Plasma concentrations of quinagolide and its metabolites during cycles 1 to 4 [ Time Frame: Within 1-5 days post randomisation, within 7-14 days post randomisation, and at menstrual cycles 1 (~1 months), 2 (~2 months), 3 (~3 months) and 4 (~4 months) ]
    Assessed by blood sample collection

  13. Changes in clinical chemistry and hematology parameters with markedly abnormal changes [ Time Frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) ]
    Assessed by blood sample collection

  14. 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

  15. 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



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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 randomisation 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


Contacts
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Contact: Global Clinical Compliance +1 833-548-1402 (US/Canada) DK0-Disclosure@ferring.com
Contact: Global Clinical Compliance +1 862-286-5200 (outside US) DK0-Disclosure@ferring.com

Locations
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Denmark
Gyneacology Rigshospitalet Recruiting
Copenhagen, Denmark
Germany
Charité Universitätsmedizin Not yet recruiting
Berlin, Germany
Universitätsklinikum Münster Not yet recruiting
Münster, Germany
Italy
Azienda Ospedaliera Universitaria Senese Not yet recruiting
Siena, Italy
Spain
Hospital Universitari i Politècnic La Fe Not yet recruiting
Valencia, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Global Clinical Compliance Ferring Pharmaceuticals

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03749109     History of Changes
Other Study ID Numbers: 000295
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Endometriosis
Adenomyosis
Genital Diseases, Female
Uterine Diseases
Quinagolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs