EndometriosisPhase 3NCT06439524
The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
A Phase 3 study testing 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate in people with Endometriosis, run by Main Line Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 1 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis
Who cannot join
- -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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Main Line Health
Wynnewood, Pennsylvania, 19096
Jordan Klebanoff, MD
About this study
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:
Read more
- 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.
Read the detailed description
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. Women over the age of 18 scheduled to undergo a laparoscopic surgery for endometriosis will be screened and if agree and consented to participate will be randomized to either Rel-CT following surgery or no post-operative hormonal suppression using a block randomization with blocks 2 and 4. The surgeon will not have access to the randomization schedule to reduce selection bias. Inclusion criteria will include: 1) Patients over the age of 18 planning to undergo an elective laparoscopic/robotic procedure for known or suspected endometriosis. Exclusion criteria will include: 1) Patients with known contraindications to REL-CT; 2) Any form of hormonal suppression of endometriosis within the protocol guidelines; 3) Primary language other than English/Spanish; 4) Patients without histologic evidence of endometriosis following their surgical procedure; 5) Patients interested in pregnancy within the 12 months following their surgical procedure.
The primary outcome will be change in Endometriosis Health Profile 30 (EHP-30) score. A preoperative EHP-30 will be completed by all patients enrolled in the study within 4 weeks of their scheduled surgical procedure and then again postoperatively at 1 month, 3 months, and 6 months. Investigators expect that postoperative use of REL-CT will lead to a clinically meaningful improvement in EHP-30 scores compared to surgery alone. In addition, investigators will gather data on our secondary outcomes: These data could be very helpful in informing providers and patients of the utility of medical suppression of endometriosis using REL-CT following surgery.
- Conditions
- Endometriosis
- Being tested
- 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetateDrug
Also called Relugolix Combination Therapy (Rel-CT), Myfembree
if randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Rel-CT | Active comparator | 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, one tablet daily for 6 months Receives: Drug: 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate |
| no study drug | No intervention | no study drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Change in EHP-30 scores between groups stratified by endometriosis stage
Comparison of EHP-30 scores according to endometriosis stage of the participant of Rel-CT group to non Rel-Ct treatment group
Measured: 6 months
Comparison of EHP-30 subscales
Comparison of EHP-30 survey subscales in treatment groups.
Measured: 6 months
Comparison of EHP-30 by superficial vs deep infiltrating types
Comparison of EHP-30 scores according to the participant having superficial or deep infiltrating endometriosis post-surgery.
Measured: 6 months
Reintervention rates between groups
Need for surgical reintervention will be assessed between treatment groups.
Measured: 6 months
Compliance rates for the study drug and office visits following surgery
Study drug adherence will be monitored and reported.
Measured: 6 months
Rates of concomitant adenomyosis
Rate of concomitant adenomyosis will be collected and compared between two treatment groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 Aug 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Sumitomo Pharma Switzerland GmbH
- Responsible party
- Sponsor
- Investigators
- Jordan Klebanoff, MD, Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439524
- Sponsor's protocol ID
- 1111
- Status last verified
- Jun 2025
- First submitted
- 29 Feb 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06439524
- Acronym / sponsor ID
- 1111
- Conditions
- Endometriosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- Pfizer, Sumitomo Pharma Switzerland GmbH
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Women over the age of 18 scheduled to undergo a laparoscopic surgery for endometriosis will be screened and if agree and consented to participate will be randomized to either Rel-CT following surgery or no post-operative hormonal suppression using a block randomization with blocks 2 and 4. The surgeon will not have access to the randomization schedule to reduce selection bias. Inclusion criteria will include: 1) Patients over the age of 18 planning to undergo an elective laparoscopic/robotic procedure for known or suspected endometriosis. Exclusion criteria will include: 1) Patients with known contraindications to REL-CT; 2) Any form of hormonal suppression of endometriosis within the protocol guidelines; 3) Primary language other than English/Spanish; 4) Patients without histologic evidence of endometriosis following their surgical procedure; 5) Patients interested in pregnancy within the 12 months following their surgical procedure.
The primary outcome will be change in Endometriosis Health Profile 30 (EHP-30) score. A preoperative EHP-30 will be completed by all patients enrolled in the study within 4 weeks of their scheduled surgical procedure and then again postoperatively at 1 month, 3 months, and 6 months. Investigators expect that postoperative use of REL-CT will lead to a clinically meaningful improvement in EHP-30 scores compared to surgery alone. In addition, investigators will gather data on our secondary outcomes: These data could be very helpful in informing providers and patients of the utility of medical suppression of endometriosis using REL-CT following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rel-CT | Active comparator | Drug: 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, one tablet daily for 6 months |
| no study drug | No intervention | –no study drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Planning to undergo an elective laparoscopic or robotic procedure for known or suspected endometriosis
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetateAlso: Relugolix Combination Therapy (Rel-CT), Myfembreeif randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis | Drug | Rel-CT |
Primary outcome
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.
Time frame: 6 months
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 secondary outcomes
Change in EHP-30 scores between groups stratified by endometriosis stage
Time frame: 6 months
Comparison of EHP-30 subscales
Time frame: 6 months
Comparison of EHP-30 by superficial vs deep infiltrating types
Time frame: 6 months
Reintervention rates between groups
Time frame: 6 months
Compliance rates for the study drug and office visits following surgery
Time frame: 6 months
Rates of concomitant adenomyosis
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Estimating the Mean and Variance from the Median, Range, and the Size of a SampleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordan Klebanoff, MD principal investigator
Main Line Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate in people with Endometriosis, run by Main Line Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Klebanoff, MD (610-896-4380, Klebanoffj@mlhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.