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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Sumitomo Pharma Switzerland GmbH | INDUSTRY |
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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:
Researchers will compare the two treatment groups (Rel-CT and non Rel-CT) to see if there is a change in EHP-30 scores.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rel-CT | Active Comparator | 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate, one tablet daily for 6 months |
|
| no study drug | No Intervention | no study drug |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Comparison of EHP-30 subscales |
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Inclusion criteria
Exclusion criteria
-A known contraindication to REL-CT. Contraindications include:
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
biological female at birth and meeting criteria for endometriosis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan Klebanoff, MD | Contact | 610-896-4380 | Klebanoffj@mlhs.org | |
| Sara Burke, MPH | Contact | 484-476-2620 | BurkeSa@mlhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Jordan Klebanoff, MD | Main Line Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Line Health | Recruiting | Wynnewood | Pennsylvania | 19096 | United States |
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| Label | URL |
|---|---|
| Estimating the Mean and Variance from the Median, Range, and the Size of a Sample | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 8, 2025 | Jun 11, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C561634 | relugolix |
| D004958 | Estradiol |
| D000077563 | Norethindrone Acetate |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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.
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Participants and providers will know if participants are assigned to the treatment arm to take Rel-CT or not.
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|
Comparison of EHP-30 survey subscales in treatment groups.
| 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. | 6 months |
| Reintervention rates between groups | Need for surgical reintervention will be assessed between treatment groups. | 6 months |
| Compliance rates for the study drug and office visits following surgery | Study drug adherence will be monitored and reported. | 6 months |
| Rates of concomitant adenomyosis | Rate of concomitant adenomyosis will be collected and compared between two treatment groups. | 6 months |
| D000091662 | Genital Diseases |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009640 | Norethindrone |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |