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
NCT04333576
· ctgov
active_not_recruiting
phase phase-3
- Enrollment
- 800
- Start
- 2020-08-10
- Completion
- 2027-07-01
- Last updated
- 2026-06-12
- Has results
- False
- Countries
- United States, Puerto Rico
Conditions
Tagged with
Interventions
-
Elagolix
DRUG
Tablet:Oral
-
Placebo
DRUG
Tablet:Oral
-
Combined Oral Contraceptive
DRUG
Tablet:Oral
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine