A phase II, randomised, double-blind, placebo-controlled, parallel-group, multi-centre study investigating efficacy and safety of Sepranolone (UC1010) in patients with PMDD

Asarina Pharma0 个研究点目标入组 250 人开始时间: 2017年9月18日最近更新: 2020年7月20日

研究概览

暂无简介。

•Subjects must:
•? be a woman between 18-45 years of age
•? have a regular menstrual cycle of 24-35 days cycle
•? use double barrier contraception, non-hormonal IUD, be abstinent or surgically sterilized
•? have PMDD according to DSM-5 verified in two menstrual cycles
•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 250
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Most important criteria. Subjects must not:
•? have any steroid hormonal treatment (including hormonal IUD, vaginal ring, cream or dermal patch) during the previous 3 months before the first study visit,
•? have been treated with any psychopharmaceuticals during the previous 3 months before the first study visit, unless for SSRI where 1 month wash-out time is acceptable,
•? have treatment during the previous 3 months before the first study visit with over-the-counter or prescription drugs for PMS symptoms,
•? have a significant medical condition ongoing in the opinion of the investigator, including any chronic psychiatric disease with a relapse in the past year,
•? have a drug or alcohol, abuse or dependency, ongoing or have a history of such abuse or dependency during the last 2 years,
•? be pregnant, given birth within the last 4 months before the first study visit, be breast-feeding or intending to become pregnant during the study period,
•? have a clinically relevant finding on the physical examination or blood testing.

发起方

Asarina Pharma