CompletedPhase 2

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

Belgium912 participantsStarted 2012-12-04

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain

Timeframe: Baseline & Week 12

Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea

Timeframe: Baseline & Week 12

Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain

Timeframe: Baseline & Week 12

Trial details

NCT IDNCT01767090

SponsorAstellas Pharma Europe B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05-13

View on ClinicalTrials.gov More Endometriosis trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain

Timeframe: Baseline & Week 12

Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea

Timeframe: Baseline & Week 12

Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain

Timeframe: Baseline & Week 12