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

Conditions

• Endometriosis

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Elagolix — DRUG
  Tablet:Oral
• Placebo — DRUG
  Tablet:Oral
• Combined Oral Contraceptive — DRUG
  Tablet:Oral

Study Details

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.

Key Dates

Start date

Aug 10, 2020

Status verified

Nov 2025

Primary completion

Mar 31, 2029

Completion

Jun 30, 2030

Study Design

Enrollment

800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Double-Blind: Placebo
  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.
• Experimental: Double-Blind: Elagolix
  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.
• Experimental: Double-Blind: Elagolix + COC
  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.

Primary Outcome Measure

Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale [ Time Frame: Month 3 ]

Locations (176)

Find similar trials in Anniston, AL

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