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

• Status: Completed
• Trial end date: 2015-07-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Leuprolide

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