Completed
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Dose-Response Relationship of ASP1707 in Subjects With Endometriosis Associated Pelvic Pain for 12 Weeks, Followed by a 12-Week Double-blind Extension Without Placebo Control, Including a 24-Week Open-Label Leuprorelin Acetate Treatment Group for Bone Mineral Density Assessment
Led by Astellas Pharma Europe B.V. · Updated on 2024-10-23
912
Participants Needed
85
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective for this study is to assess the efficacy and dose-response relationship of ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response relationship of ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of endometriosis associated pain and 24-week safety and tolerability of ASP1707.
CONDITIONS
Brief Title
A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
Who Can Participate
Eligibility Criteria
Inclusion Criteria:
- Pre menopausal female adults with confirmed length and regular menstrual cycle
- Surgically diagnosed endometriosis
- Moderate to severe endometriosis related pain
Exclusion Criteria:
- Hormonal contraceptives or other drugs with effects on gynecological endocrinology
- Surgery for endometriosis within the 4 weeks prior to entry
- Uterine myoma
- Abnormal vaginal bleeding
- Hysterectomy or bilateral oophorectomy
- Pelvic infection
- Relevant abnormalities at gynecological exam at screening
- Disease with chronic abdominal pain of non-endometriosis origin
- Pituitary adenoma
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