A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis- Associated Pai

Phase 1

• Conditions: Moderate to Severe Endometriosis Associated Pain; MedDRA version: 19.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2011-004295-11-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-08
• Study Completion: 2016-12-19
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 815

Inclusion Criteria

1.) Premenopausal female, between 18 and 49 years of age, inclusive, at time of signing consent. 2.) Clinical diagnosis of endometriosis (laproscopy or laparotomy) performed within 10 years of entry into the Washout Period. 3.) Agrees to use required birth control methods during the entire length of participation in the study. 4.) Subject has a Composite Pelvic Signs and Symptoms Score total score of = 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5.) Subjects must have at least two menstrual cycles with an interval 24-38 days within the Screening Period, prior to Day 1.

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 788
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.) Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period 2.) Subject has a history of previous non-response to GnRH agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary). 3.) Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, which would interfere with the assessment of endometriosis related pain. 4.) Clinically significant gynecological condition identified on Screening transvaginal ultrasound. 5.) Subject has a history of osteoporosis or other metabolic bone disease. 6.) Subject has a current history of undiagnosed abnormal uterine bleeding.

Study & Design

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