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.

Myovant Sciences GmbH0 个研究点目标入组 85 人开始时间: 2018年5月7日最近更新: 2019年6月30日

试验速览

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•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.

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