A study to investigate the sex-hormone-stimulant study drug MVT-602 in healthy fertile women.
- Conditions
- Female infertilityMedDRA version: 20.0 Level: LLT Classification code 10021935 Term: Infertility, female, associated with anovulation System Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2018-001379-20-NL
- Lead Sponsor
- Myovant Sciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 85
Subject is a premenopausal female between 18 and 35 years of age inclusive, at the time of the screening visit.
A reference is made to the protocol for more inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, gynecologic or endocrine disease (including type 1 or 2 diabetes mellitus) or other abnormality that may impact the ability of the subject to participate or potentially confound the study results.
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.
A reference is made to the protocol for more exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method