NCT01767090

A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 912 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

• Endometriosis

Interventions

Type	Name	Description
DRUG	ASP1707	Oral
DRUG	Placebo	Oral
DRUG	Leuprorelin acetate	subcutaneous

Timeline

• Start date: 2012-12-04
• Primary completion: 2015-05-13
• Completion: 2015-07-30
• First posted: 2013-01-14
• Last updated: 2024-10-23

Locations

85 sites across 9 countries: Belgium, Bulgaria, Germany, Hungary, Japan, Poland, Romania, Ukraine, United Kingdom