A Phase 3 clinical trial (NCT04173169) investigating elagolix as a pre-IVF treatment for women with endometriosis-related infertility completed its primary data collection on 2025-05-02. This significant milestone means that all data for the trial's primary outcome has been gathered, moving the study closer to analysis and potential reporting of results. The trial aimed to evaluate if pretreatment with the GnRH antagonist could improve live birth rates in this patient population.
Background
Elagolix, marketed as Orilissa and Oriahnn, is an oral gonadotropin-releasing hormone (GnRH) antagonist. This class of drugs works by suppressing ovarian hormone production, which can reduce the pain associated with endometriosis. In this trial, it is being investigated for its potential role in improving outcomes for women with endometriosis-related infertility who are undergoing in vitro fertilization (IVF), a common treatment for infertility.
Trial design
The study, titled "Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis" (NCT04173169), was a Phase 3, randomized clinical trial. It enrolled 103 participants diagnosed with both infertility and endometriosis. The intervention involved administering elagolix 200 mg as a pre-IVF treatment. The trial design compared the outcomes in women who received pretreatment with the GnRH antagonist against those who did not, with the central hypothesis being that live birth rates would improve in the pretreated group.
What this means
The completion of primary data collection for this Phase 3 trial is a crucial development, indicating that the study has reached a key stage in its progression. This trial is designed to provide robust evidence on the potential benefits of elagolix as a pretreatment for women with endometriosis-related infertility undergoing IVF. Clinicians and researchers will now look forward to the comprehensive analysis and subsequent publication of the trial results, which will shed light on the efficacy and safety profile of this specific pretreatment strategy and its implications for patient care.
Source
The information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a publicly accessible database of clinical studies maintained by the U.S. National Library of Medicine. The record for study NCT04173169, titled "Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis," was updated with the primary completion date of 2025-05-02 on clinicaltrials.gov.