A Phase 3 multicenter, randomized, double-blind, placebo-controlled, clinical study to assess the efficacy and safety of linzagolix in subjects with moderate to severe endometriosis-associated pain. - Edelweiss 3

ObsEva S.A.0 个研究点目标入组 486 人开始时间: 2019年8月2日最近更新: 2023年10月23日

适应症

试验速览

暂无简介。

•1. The subject must have had her most recent surgical and – if available – histological diagnosis of pelvic endometriosis (laparoscopy, laparotomy, vaginal fornix or other biopsy) up to 10 years before screening.
•2. The subject has moderate to severe endometriosis- associated pain during the screening period.
•3. The subject has regular menstrual cycles.
•4. The subject has a Body BMI = 18 kg/m2 at the screening visit.
•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 450
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
•2. The subject is less than 6 months postpartum or 3 months post-abortion/miscarriage at the time of entry into the screening period.
•3. The subject has a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
•4. The subject did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
•5. The subject has a history of, or known, osteoporosis, hyperparathyroidism, or other metabolic bone disease.
•6. The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.
•7. The subject has calcium level above the upper limit of normal range at screening, which is confirmed on repeat fasting testing at Screening.
•8. The subject has a history of, or active malignancy (with or without systemic chemotherapy) (except treated basal carcinoma of the skin which is not an exclusion criterion)
•9. The subject has a history of attempted suicide and/ or a history of, or known major psychiatric disorders that are not well controlled.

发起方

ObsEva S.A.