A double-blind randomized extension study to assess the long-term efficacy and safety of linzagolix in subjects with endometriosis-associated pain. - Edelweiss 3 extension

ObsEva S.A.0 个研究点目标入组 288 人开始时间: 2020年1月10日最近更新: 2023年1月9日

研究概览

暂无简介。

•1. The subject must provide a written informed consent specific to this study prior to starting the extension study treatment.
•2. The subject has completed the 6-month treatment in the main study.
•3. The subject is willing and able to continue to comply with the requirements of the study protocol for the duration of the extension study.
•4. The subject must agree to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods.
•5. If of childbearing potential, the subject agrees to continue to use one of the permitted by the protocol birth control methods during the entire Treatment Period of the study and until 3 months after the end of treatment.
•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 288
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. The subject is pregnant or is planning a pregnancy within the duration of the study (including the Follow-up Period).
•2. The subject is likely to require treatment during the study with any of the medications prohibited by the protocol.
•3. The subject is likely to require medical marijuana during the study. Recreational use of marijuana is allowed as long as in the investigator’s opinion there is no abuse. This exclusion criterion is applicable only in countries/states where use of marijuana is legalized.
•4. The subject has any other clinically significant gynecologic condition identified on TVUS or endometrial biopsy or at the manual breast examination during the main study, which might interfere with the study efficacy and safety objectives.
•5. The subject has met any of the main study discontinuation criteria.
•6.The subject has any condition that, in the opinion of the Investigator, constitutes a risk or a contraindication to the participation of the subject in this extension study or that could interfere with the study objectives, conduct or assessments.

发起方

ObsEva S.A.