A study to assess the effectiveness and safety of different doses of ASP1707 compared to placebo for endometriosis associated pelvic pai

• Conditions: endometriosis associated pelvic pain; MedDRA version: 17.1Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-002791-14-BG
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-15
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 504

Inclusion Criteria

- pre menopausal female adults with confirmed length and regular menstrual cycle
- surgically diagnosed endometriosis
-moderate to severe endometriosis related pain (dysmenorrhea and
non-menstrual pelvic pain)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 504
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- hormonal contraceptives or other drugs with effects on
gynecological endocrinology
- surgery for endometriosis is within 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 nonendometriosis
origin
- pituitary adenoma
- use of drugs metabolized by CYP3A4 or anticoagulants or drugs with effects on BMD

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified