drugset / Trial / NCT01767090

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

NCT01767090

Phase 2 Completed 912 enrolled Astellas Pharma Europe B.V.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-12-04
Primary completion
2015-05-13
Completion
2015-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leuprolide Other / unclassified Subcutaneous
Subject OPIGOLIX Other / unclassified 3 mg Oral
Subject OPIGOLIX Other / unclassified 5 mg Oral
Subject OPIGOLIX Other / unclassified 10 mg Oral
Subject OPIGOLIX Other / unclassified 15 mg Oral

Indications