Endometriosis is a painful uterine condition that affects 6-10% of women of reproductive age. Endometriosis has an impact on everyday life, social interactions, sexuality and sexual activity, as well as mental health. This research will see how effectively elagolix works in the body when used with combined oral contraceptives (COC) and/or how safe it is compared to a placebo (does not contain treatment drug). Participants with endometriosis and related pain will be evaluated for their response to dysmenorrhea (painful periods).
The primary objective is to evaluate the efficacy of elagolix when added to a COC regimen in women with endometriosis and related dysmenorrhea, in reducing pain associated with menstruation, which is measured by:
- The mean number of days with moderate or severe menstrual cramps (primary endpoint).
- The number of days with vaginal bleeding.
Secondary objectives are to compare the effects of elagolix therapy when it is added to a COC regimen and used alone, and to establish an effect size for dysmenorrhea at the end of the treatment period (to estimate clinical meaningfulness).
- Evaluating Whether the Study medication (approved), when taken together with an approved birth control pill to reduce moderate to severe endometriosis pain.
- Study last up to 18-month Period.
- Premenopausal females (18 to 49) years of age.
- Have had surgical confirmation of endometriosis and associated moderate to severe pain.
- Subjects must not be pregnant or breastfeeding.
- Subjects must not have a surgical history of hysterectomy or bilateral oophorectomy.
- Patient reimbursement for participation.
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Frequently Asked Questions.
A clinical research trial is a scientific research aimed at testing the efficacy and safety of an investigational/experimental drug, medical device or any set of procedures which claims to improve a disease or a medical condition. The research also establishes the quantity of drug needed, any side effects, potential benefits and risks associated with its use. The US Food and Drug Administration (FDA) evaluates the results of such trials before approving any medication for general use in the United States.
When considering participating in a trial, discuss it with your doctor and the clinical research team. You may want to fully understand following before consenting to be a part of the trial:
- The objectives of study
- Potential benefits, risks or discomfort associated with the trial
- Duration of the trial
- Travel and Time commitments
- Any medical tests that you may require
- Any previous experience of people who have undertaken the trial.
- Your medical assistance requirements
- Any treatment alternatives if you choose not to participate in the study