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Can a daily pill after endometriosis surgery keep pain away?

NCT ID NCT06439524

Disease control Sponsor: Main Line Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether taking Relugolix combination therapy (Rel-CT) right after endometriosis surgery leads to better quality of life and less chance of the disease coming back. About 110 women having laparoscopic or robotic surgery for endometriosis will be randomly assigned to either take Rel-CT daily for 6 months after surgery or have surgery alone. Researchers will compare changes in a 30-question health survey at 1, 3, and 6 months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Relugolix combination therapy (Rel-CT) – a daily tablet containing relugolix, estradiol, and norethindrone acetate
What this could lead to
If it works, this could show that starting Rel-CT right after surgery improves quality of life and lowers the chance endometriosis comes back, possibly reducing the need for repeat surgery.
What could go wrong
This is a single-site trial with 110 participants, so results may not apply to everyone. Rel-CT has side effects like blood clot risk and bone thinning, and it requires ongoing medication, not a one-time fix.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Age ≥ 18 years * Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis Exclusion criteria -A known contraindication to REL-CT. Contraindications include: * High risk of arterial, venous thrombotic, or thromboembolic disorder * Pregnancy Known osteoporosis * Current or history of breast cancer or other hormone-sensitive malignancies * Known hepatic impairment or disease * Undiagnosed abnormal uterine bleeding * Known hypersensitivity to components of Rel-CT * The patient did not discontinue hormonal suppression within the required timeline: Trans-Dermal, Oral Medication, Patch, or Vaginal Ring: day before surgery Intrauterine Device or Sub-Dermal Implant: removed at surgery Injectable Medication: at least 12 weeks before surgery * Primary language other than English/Spanish * Interested in pregnancy within the 6 months following the surgical procedure. * If pregnancy test performed during pre-surgical work up is positive, the patient will no longer be a candidate for endometriosis surgery and will therefore not be eligible for the study. * Patients without histologic evidence of endometriosis following their surgical procedure will be removed from the study prior to receiving the study intervention. * Patients who undergo a surgical intervention more invasive than the planned laparoscopic or robotic excisional surgery, such as open abdominal surgical repair, will be removed from the study prior to receiving the study intervention.

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Conditions

The condition(s) this trial relates to.

endometriosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometriosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Main Line Health

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

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