The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial

NCT06439524 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 1111
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Endometriosis

Outcome Measures

Primary Outcomes (1)

• This study aims to determine if immediate postoperative medical suppression with Regugolix combination therapy (Rel-CT) following excisional surgery for endometriosis is superior to surgery alone.

  The study will assess quality of life via change in total Endometriosis Health Profile 30 (EHP-30) scores following excisional surgery for endometriosis from baseline to 6 months postoperatively.

  6 months

Secondary Outcomes (6)

• Change in EHP-30 scores between groups stratified by endometriosis stage

  6 months

• Comparison of EHP-30 subscales

  6 months

• Comparison of EHP-30 by superficial vs deep infiltrating types

  6 months

• Reintervention rates between groups

  6 months

• Compliance rates for the study drug and office visits following surgery

  6 months

Study Arms (2)

Rel-CT

ACTIVE COMPARATOR

40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, one tablet daily for 6 months

Drug: 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate

no study drug

NO INTERVENTION

no study drug

Interventions

40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate DRUG

if randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis

Also known as: Relugolix Combination Therapy (Rel-CT), Myfembree

Rel-CT

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: biological female at birth and meeting criteria for endometriosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Main Line Health: lead
• Pfizer: collaborator
• Sumitomo Pharma Switzerland GmbH: collaborator

Study Sites (1)

Main Line Health

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Related Links

• Estimating the Mean and Variance from the Median, Range, and the Size of a Sample

MeSH Terms

Conditions

Endometriosis

Interventions

relugolix; Estradiol; Norethindrone Acetate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norethindrone; Norpregnenes; Norpregnanes; Norsteroids

Study Officials

• Jordan Klebanoff, MD

  Main Line Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Klebanoff, MD

CONTACT

610-896-4380; Klebanoffj@mlhs.org

Sara Burke, MPH

CONTACT

484-476-2620; BurkeSa@mlhs.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and providers will know if participants are assigned to the treatment arm to take Rel-CT or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design of this study will be an unblinded randomized controlled trial of medical suppression with once daily Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis performed by high volume minimally invasive gynecologic surgeons. Researchers will use descriptive statistics to compare the demographics and clinical characteristics of the groups with chi-square and two-sample t-tests. The median differences in EHP-30 from baseline to 6 months will be compared between groups with Mann Whitney U test. The 95% confidence interval of the difference between group medians will be used to measure superiority.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: June 3, 2024
• Study Start: August 15, 2024
• Primary Completion: February 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)