Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
Condition: Endometriosis
MeSH terms: Endometriosis; Adenomyosis
Intervention: Quinagolide 1080 µg; Placebo
Intervention description: Vaginal ring containing Quinagolide 1080 µg for daily releases; Matching placebo
Intervention MeSH terms: Quinagolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Endometrioma; Adenomyosis; Deep infiltrating endometriosis

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.
    

Eligibility 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)