Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
NCT03749109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2023-08-07
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.
Conditions
- Endometriosis
Interventions
- DRUG
-
Quinagolide 1080 µg
Vaginal ring containing Quinagolide 1080 µg for daily releases
- DRUG
-
Matching placebo
Sponsors & Collaborators
-
Ferring Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Global Clinical Compliance · Ferring Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-19
- Primary Completion
- 2021-06-21
- Completion
- 2021-07-18
- FDA Drug
- Yes
Countries
- Denmark
- Germany
- Italy
- Poland
Study Locations
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