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

Ferring

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: Quinagolide 1080 µg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03749109

000295

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

Quinagolide 1080 µg

Experimental group

Description:

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

Treatment:

Drug: Quinagolide 1080 µg

Placebo

Placebo Comparator group

Description:

Vaginal ring containing matching placebo

Treatment:

Drug: Placebo