Overview

This trial is active, not recruiting.

Condition endometriosis
Treatments elagolix, placebo
Phase phase 3
Sponsor AbbVie
Start date May 2013
End date January 2016
Trial size 788 participants
Trial identifier NCT01931670, 2011-004295-11, M12-671

Summary

A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
6 Month Treatment Period
elagolix ABT-620, elagolix sodium
Elagolix Dose 1 for 6 month Treatment Period, Elagolix Dose 2 for the 6 month Treatment Period
(Experimental)
6 Month Treatment Period
elagolix ABT-620, elagolix sodium
Elagolix Dose 1 for 6 month Treatment Period, Elagolix Dose 2 for the 6 month Treatment Period
(Placebo Comparator)
6 Month Treatment with matching Placebo
placebo
Placebo for 6 Month Treatment Period

Primary Outcomes

Measure
Proportion of responders with Endometriosis Associated Pain assessed using modified Biberoglu and Behrman (B&B) scale
time frame: Up to Month 3
Change from Baseline in Bone Mineral Density
time frame: From Month 0 to Month 18
Change in Endometrial Thickness assessed by Transvaginal Ultrasound (TVU)
time frame: From Month 0 to Month 6
Change in percentage of subjects with significant Transvaginal Ultrasound (TVU) findings
time frame: From Month 0 to Month 6

Secondary Outcomes

Measure
Change in Clinical Laboratory Tests
time frame: From Month 0 to Month 9
Proportion of subjects with Adverse Events
time frame: Up to Month 18

Eligibility Criteria

Female participants from 18 years up to 49 years old.

Inclusion Criteria: 1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent. 2. Clinical diagnosis of endometriosis (laparoscopy 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 regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1. 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 gonadotropin-releasing hormone (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. 3. Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain. 4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy. 5. Subject has a history of osteoporosis or other metabolic bone disease. 6. Subject has a current history of undiagnosed abnormal uterine bleeding.

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Description The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.