Status:
ACTIVE_NOT_RECRUITING
Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain
Lead Sponsor:
AbbVie
Conditions:
Endometriosis
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
Brief Summary
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental ...
Eligibility Criteria
Inclusion
- Documented surgical confirmation of endometriosis and associated moderate to severe pain.
- Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study.
- Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs).
Exclusion
- Pregnant or breastfeeding or planning a pregnancy until completion of the study.
- Surgical history of hysterectomy or bilateral oophorectomy.
- Participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from Screening.
- Participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04333576
Start Date
August 10 2020
End Date
June 1 2030
Last Update
November 19 2025
Active Locations (179)
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1
Pinnacle Research Group /ID# 217062
Anniston, Alabama, United States, 36207
2
ACCEL Research Sites /ID# 218044
Birmingham, Alabama, United States, 35218
3
Alabama Clinical Therapeutics /ID# 217166
Birmingham, Alabama, United States, 35235-3430
4
Alabama Clinical Therapeutics /ID# 222301
Birmingham, Alabama, United States, 35235-3430