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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

Testing a new medication for endometriosis-related pain in women.

Recruiting
18-49 years
Female
Phase 3

Endometriosis is a condition causing painful periods, affecting about 6-10% of women who can have babies. This study checks how well a drug named elagolix, combined with birth control pills (COC), helps women with endometriosis pain. A placebo is a pill that looks like real medicine but doesn't contain any active drug. Participants are randomly placed in one of three groups: one group gets elagolix, another group gets a placebo, and the third receives a combination. Women with endometriosis pain who still have periods can join. About 800 women will be part of the study in the United States, including Puerto Rico. For three months, they will take either elagolix or placebo with COC. After three months, all will take elagolix with COC for up to 18 months.

  • The study lasts up to 18 months with regular clinic visits for check-ups.
  • Participants may experience higher treatment burden compared to usual care.
  • There is a 1 in 3 chance of receiving a placebo in the first 3 months.

Regular health assessments, blood tests, and questionnaires will monitor the drug's effects and safety.

Study details
    Endometriosis

NCT04333576

AbbVie

11 January 2025

Step 1 Get in touch with the nearest study center
Entire USA
Results (undefined sites found)
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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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