Overview

This trial is active, not recruiting.

Condition endometriosis
Treatment elagolix
Phase phase 3
Sponsor AbbVie
Start date May 2014
End date June 2016
Trial size 500 participants
Trial identifier NCT02143713, 2013-001047-31, M12-821

Summary

A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis associated pain in adult pre-menopausal female subjects who completed 6 months treatment in Study M12-671.

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)
Elagolix lower daily dose
elagolix
Two different doses with matching placebo (to maintain blind) daily in two different arms over a 6-Month Treatment Period
(Experimental)
Elagolix higher dose twice daily
elagolix
Two different doses with matching placebo (to maintain blind) daily in two different arms over a 6-Month Treatment Period

Primary Outcomes

Measure
Endometriosis-Associated Pain
time frame: Month 6 of Treatment Period
Bone Mineral Density (DXA scan)
time frame: Month 6 of Treatment Period
Transvaginal Ultrasound (TVU)
time frame: Month 6 of Treatment Period
Bone Mineral Density (DXA scan)
time frame: Month 6 of Follow-up Period
Bone Mineral Density (DXA scan)
time frame: Month 12 of Follow-up Period

Secondary Outcomes

Measure
Clinical Laboratory Tests (standard laboratory values including hormones)
time frame: Month 6 of Treatment Period
Number of study subjects with Adverse Events
time frame: Up to Month 18
Clinical Laboratory Tests (standard laboratory values including hormones)
time frame: Month 3 of Follow-up Period

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - Subject has completed the 6-Month Treatment Period in pivotal study M12-671. - Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period Exclusion Criteria: - Clinically significant gynecological condition - Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip - Plans to become pregnant in the next 18 months

Additional Information

Official title Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.