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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439524
• Other study ID #: 1111
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: Main Line Health
• Contact: Jordan Klebanoff, MD
• Phone: 610-896-4380
• Email: Klebanoffj[@]mlhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this 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.

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 4-weeks of the index surgical procedure; 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: April 2027
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women over the age of 18 planning to undergo an elective laparoscopic/ robotic procedure for known or suspected endometriosis.

Exclusion Criteria:

• Patients with known contraindications to Rel-CT

• Patients taking any form of hormonal suppression of endometriosis within 4-weeks of the index surgical procedure

• Primary language other than English/Spanish

• Patients without histologic evidence of endometriosis following their surgical procedure

• Patients interested in pregnancy within the 12 months following their surgical procedure

• Surgical intervention more invasive than the planned laparoscopic or robotic excisional surgery, such as open abdominal surgical repair.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• 40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
if randomized to study drug, participants will take one tablet Rel-CT daily following excisional surgery for endometriosis

Locations

Country	Name	City	State
United States	Main Line Health	Wynnewood	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Main Line Health	Pfizer, Sumitomo Pharma America, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

Agarwal SK, Chapron C, Giudice LC, Laufer MR, Leyland N, Missmer SA, Singh SS, Taylor HS. Clinical diagnosis of endometriosis: a call to action. Am J Obstet Gynecol. 2019 Apr;220(4):354.e1-354.e12. doi: 10.1016/j.ajog.2018.12.039. Epub 2019 Jan 6. — View Citation

Bafort C, Beebeejaun Y, Tomassetti C, Bosteels J, Duffy JM. Laparoscopic surgery for endometriosis. Cochrane Database Syst Rev. 2020 Oct 23;10(10):CD011031. doi: 10.1002/14651858.CD011031.pub3. — View Citation

Burks C, Lee M, DeSarno M, Findley J, Flyckt R. Excision versus Ablation for Management of Minimal to Mild Endometriosis: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2021 Mar;28(3):587-597. doi: 10.1016/j.jmig.2020.11.028. Epub 2020 D — View Citation

Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469. — View Citation

Giudice LC, As-Sanie S, Arjona Ferreira JC, Becker CM, Abrao MS, Lessey BA, Brown E, Dynowski K, Wilk K, Li Y, Mathur V, Warsi QA, Wagman RB, Johnson NP. Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associate — View Citation

Hornstein MD, Hemmings R, Yuzpe AA, Heinrichs WL. Use of nafarelin versus placebo after reductive laparoscopic surgery for endometriosis. Fertil Steril. 1997 Nov;68(5):860-4. doi: 10.1016/s0015-0282(97)00360-9. — View Citation

Kaser DJ, Missmer SA, Berry KF, Laufer MR. Use of norethindrone acetate alone for postoperative suppression of endometriosis symptoms. J Pediatr Adolesc Gynecol. 2012 Apr;25(2):105-108. doi: 10.1016/j.jpag.2011.09.013. Epub 2011 Dec 11. — View Citation

Rindos NB, Fulcher IR, Donnellan NM. Pain and Quality of Life after Laparoscopic Excision of Endometriosis. J Minim Invasive Gynecol. 2020 Nov-Dec;27(7):1610-1617.e1. doi: 10.1016/j.jmig.2020.03.013. Epub 2020 Apr 6. — View Citation

Roman H, Chanavaz-Lacheray I, Hennetier C, Tuech JJ, Dennis T, Verspyck E, Merlot B. Long-term risk of repeated surgeries in women managed for endometriosis: a 1,092 patient-series. Fertil Steril. 2023 Oct;120(4):870-879. doi: 10.1016/j.fertnstert.2023.05 — View Citation

Yap C, Furness S, Farquhar C. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database Syst Rev. 2004;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2. — View Citation

Zondervan KT, Becker CM, Missmer SA. Endometriosis. N Engl J Med. 2020 Mar 26;382(13):1244-1256. doi: 10.1056/NEJMra1810764. No abstract available. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Comparison of EHP-30 subscales	Comparison of EHP-30 survey subscales in treatment groups.	6 months
Secondary	Reintervention rates between groups	Need for surgical reintervention will be assessed between treatment groups.	6 months
Secondary	Compliance rates for the study drug and office visits following surgery	Study drug adherence will be monitored and reported.	6 months
Secondary	Rates of concomitant adenomyosis	Rate of concomitant adenomyosis will be collected and compared between two treatment groups.	6 months

External Links

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