Relugolix Phase 3 Endometriosis Trial Completes Primary Data Collection

By Hipa.ai Research · February 15, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

The Phase 3 trial (NCT06439524) investigating relugolix combination therapy for endometriosis is scheduled for primary completion on 2026-02-15. This study aims to compare the quality of life in participants receiving medical management with relugolix after excisional surgery for endometriosis versus those who do not.

Background

Relugolix combination therapy (Rel-CT), which includes relugolix, estradiol hemihydrate, and norethindrone acetate, is an FDA-approved medical treatment for endometriosis. It is known to be effective in managing endometriosis pain. The current trial explores its benefit when initiated immediately following excisional surgery.

Trial design

The Phase 3 trial, NCT06439524, titled "The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial," is an investigator-initiated single-site study. It has an enrollment target of 110 participants diagnosed with endometriosis. The study is designed to compare the overall quality of life of participants receiving relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate) immediately following excisional surgery for endometriosis, against those who do not receive this medical management after the same surgery.

What this means

The primary completion of this Phase 3 trial signifies that all data collection for the primary outcome measure is anticipated to be complete. This study is designed to provide crucial insights into the potential benefits of initiating relugolix combination therapy immediately after excisional surgery for endometriosis, specifically regarding its impact on participants' overall quality of life. The findings, once available, will help inform clinical practice regarding optimal post-surgical management strategies for endometriosis.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06439524, titled "The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial," indicates a primary completion date of 2026-02-15 on clinicaltrials.gov.