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NCT06439524 · ClinicalTrials.gov registry record · Phase 3
The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
A Phase 3 study of Endometriosis, sponsored by Main Line Health.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT06439524 is a Phase 3 study of Endometriosis that is actively recruiting participants, run by Main Line Health. The registered enrollment target is 110 participants, below the 262-participant average among 48 other Endometriosis trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06439524, a Phase 3 study of Endometriosis, is actively recruiting participants, sponsored by Main Line Health.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this investigator-initiated single-site clinical trial is to compare the overall quality of life of participants taking Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis to participants that do not take Rel-CT following the same surgery. Rel-CT is an FDA approved form of medical treatment for endometriosis. It is known to work in treating endometriosis pain. However, investigators do not know whether or not there is a benefit to beginning Rel-CT immediately following surgery. This study will test if patients who take Rel-CT after surgery have better quality of life and less chance the endometriosis comes back, requiring additional surgery. The main question it aims to answer is: \- Does taking Rel-CT following excisional surgery for endometriosis result in higher Endometriosis Health Profile 30 (EHP-30) scores, indicating a positive impact on overall health-related quality of life and well-being? Participants will: * Be randomly assigned to one of two treatment groups. One treatment group will take study drug Rel-CT after having excisional surgery, and the other treatment group will just have the surgery alone. * Be asked to complete questionnaires, called the Endometriosis Health Profile 30 (EHP-30) at 4 timepoints. The first time is before surgery, then at follow-up visits at 1 month, 3 months, and 6 months. The survey has 30 questions that ask about pain, control, powerlessness, emotional well-being, social support, and self-image. Researchers will compare the two treatment groups (Rel-CT and non Rel-CT) to see if there is a change in EHP-30 scores.
Conditions Studied
Interventions
- DRUG 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
Study Locations (1)
Pennsylvania
- Main Line Health - Wynnewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2024-08-15 |
| Est. Completion | 2026-08-15 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06439524
The ClinicalTrials.gov registry entry for NCT06439524 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 262-participant average among 48 other Endometriosis trials with a reported enrollment target (58% lower). The listed sponsor is Main Line Health, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Endometriosis appearing as the primary indexed condition, and to 1 intervention - of which 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate is the first listed.
NCT06439524 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06439524 about?
NCT06439524 is a clinical study titled "The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial". The goal of this investigator-initiated single-site clinical trial is to compare the overall quality of life of participants taking Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis to participants that do not take Rel-CT following the same surgery. Rel-CT is an F...
What is the current status of trial NCT06439524?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2024-08-15. Estimated completion is 2026-08-15.
What conditions does trial NCT06439524 study?
This clinical trial studies the following conditions: Endometriosis.
What interventions are being tested in trial NCT06439524?
The interventions under investigation include: 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate (DRUG).
Who is sponsoring clinical trial NCT06439524?
This trial is sponsored by Main Line Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06439524 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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