NCT06439524RecruitingPhase 3
The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 29 Feb 2024
- Start date
- 15 Aug 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Main Line Health
- Diseases
- Endometriosis
- NCT number
- NCT06439524
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 110
- From 15 Aug 2024 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other illness
- High risk of arterial, venous thrombotic, or thromboembolic disorder
- 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
Other
- -A known contraindication to REL-CT. Contraindications include:
- Pregnancy Known osteoporosis
- Primary language other than English/Spanish
Who the study is looking for
- Age ≥ 18 years
- Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Main Line Health Coordinator of this site? Confirm its status | Wynnewood | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.