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:
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).
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:
Royal Research, Corp specializes in conducting Clinical Trials Phases I through IV, for select participants in Miami, Broward and nearby locations. Our goal is to assist our healthcare industry by conducting medical studies to discover and develop investigational medication, procedures, treatments and devices to improve the quality of life around the world. We have made our research facility comfortable for all of our participants putting their health and safety first.