Overview

This trial has been completed.

Condition endometriosis
Treatments elagolix, placebo
Phase phase 3
Sponsor AbbVie
Start date September 2013
End date January 2016
Trial size 815 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 based on daily assessment of Dysmenorrhea (DYS)
time frame: At Month 3
Proportion of responders based on daily assessment of Non-menstrual pelvic pain (NMPP)
time frame: At Month 3

Secondary Outcomes

Measure
Change from baseline to each month in Numeric rating scale (NRS) scores
time frame: From Baseline (Prior to administering study drug) to Month 3
Change from baseline to each month in Dysmenorrhea (DYS)
time frame: From Baseline (Prior to administering study drug) to Month 6
Change from baseline to each month in Non-menstrual pelvic pain (NMPP)
time frame: From Baseline (Prior to administering study drug) to Month 6
Change from baseline in analgesic use across both classes of rescue analgesics based on pill counts
time frame: Baseline (Prior to administering study drug), Month 3 and Month 6
Change from baseline to each month in dyspareunia
time frame: From Baseline (Prior to administering study drug) to Month 3
Change from baseline in use of narcotic class of medication based on pill counts
time frame: From Baseline (Prior to administering study drug) to Month 3
Proportion of responders for each month, except month 3, in DYS
time frame: Up to Month 6
Proportion of responders at each month for dyspareunia
time frame: Up to Month 6
Change from baseline to each month, except Month 6, in the mean pain score for DYS
time frame: From Baseline (Prior to administering study drug) to Month 6
Change from baseline to each month, except Month 3, in the mean pain score of dyspareunia
time frame: From Baseline (Prior to administering study drug) to Month 6
Change from baseline to each month, except Months 3 and 6, in analgesic use across both classes of rescue analgesics to treat endometriosis-related pain
time frame: From Baseline (Prior to administering study drug) to Month 6
Patient Global Impression of Change (PGIC) questionnaire
time frame: Up to Month 6
Change from baseline to each month, except month 3, in NRS scores
time frame: From Baseline (Prior to administering study drug) to Month 6
Change from baseline to each scheduled assessment in the pain domain of Endometriosis Health Profile-30 (EHP-30) questionnaire scores
time frame: From Baseline (Prior to administering study drug) to Month 6
Change from baseline to each scheduled assessment in the sexual relationship domain of EHP-30 questionnaire scores
time frame: From Baseline (Prior to administering study drug) to Month 6
Change from baseline to each scheduled assessment in Health Related Productivity Questionnaire (HRPQ) scores
time frame: From Baseline (Prior to administering study drug) to Month 6
Number of endometriosis-related non-study health visits
time frame: Up to Month 6
Number of days in the hospital
time frame: Up to Month 6
Assessing type of procedures performed
time frame: Up to Month 6
Proportion of responders for each month, except month 3, in NMPP
time frame: Up to Month 6
Change from baseline to each month, except Month 6, in the mean pain score for NMPP
time frame: From Baseline (Prior to administering study drug) to Month 6

Eligibility Criteria

Female participants from 18 years up to 49 years old.

Inclusion Criteria

  • Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
  • Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.
  • Agrees to use required birth control methods during the entire length of participation in the study.
  • 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.
  • 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

  • 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.
  • 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.
  • 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.
  • Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
  • Subject has a history of osteoporosis or other metabolic bone disease.
  • 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 January 2017.
Information provided to ClinicalTrials.gov by AbbVie.