A Phase 2a Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel Group, Dose-Range Finding Study of MVT-602 in Healthy Premenopausal Women Undergoing Controlled Ovarian Stimulation (COS) Using a Minimal Stimulation Protocol.
Phase 2
Completed
- Conditions
- female infertilityinduction of ovulation10013356
- Registration Number
- NL-OMON46304
- Lead Sponsor
- Myovant Sciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 85
Inclusion Criteria
Premenopausal female between 18 and 35 years of age inclusive, at the time of the screening visit.
Exclusion Criteria
Clinical significant abnormalities at medical research;Subject has a history of menstrual cycle length that is typically shorter than 21 days or longer than 35 days when not using hormonal contraception.;Subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV), human immunodeficiency virus (HIV) antibody, determined from the screening visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To characterize the exposure-response relationship of MVT-602 effects on<br /><br>luteinizing hormone (LH) concentrations after subcutaneous administration of<br /><br>single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women<br /><br>undergoing COS to inform dose selection of MVT-602 for subsequent studies.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety parameters including adverse events, vital sign measurements, clinical<br /><br>laboratory tests, electrocardiogram (ECG) parameters</p><br>