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

Study Overview
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Brief Summary
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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 health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official Title
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A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Elagolix
* Drug: Placebo
* Drug: Combined Oral Contraceptive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Double-Blind: Placebo<br>Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months. | Drug: Elagolix<br>* Tablet:Oral<br>* Other names: Orilissa;Drug: Placebo<br>* Tablet:Oral<br>Drug: Combined Oral Contraceptive<br>* Tablet:Oral<br>|
| Experimental: Double-Blind: Elagolix<br>Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months. | Drug: Elagolix<br>* Tablet:Oral<br>* Other names: Orilissa;Drug: Combined Oral Contraceptive<br>* Tablet:Oral<br>|
| Experimental: Double-Blind: Elagolix + COC<br>Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months. | Drug: Elagolix<br>* Tablet:Oral<br>* Other names: Orilissa;Drug: Combined Oral Contraceptive<br>* Tablet:Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale | DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale | NMPP response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use. | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Elagolix, Combined oral contraceptives (COC), Orilissa, Dysmenorrhea