NCT05487092

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Endometriosis is a chronic inflammatory disease that affects approximately 10-15% of women of reproductive age. Symptoms include dysmenorrhoea, chronic pelvic pain, dyspareunia and infertility. Removal of the endometriotic cyst (chocolate cyst) by surgery is a well-established treatment for symptomatic relief. However, recurrence of endometriotic cyst after surgical removal of the cyst is up to 30-50% after ovarian surgery. Oral contraceptive pills for 18-24 months after the surgery is widely used as a postoperative hormonal therapy because it has been shown to reduce the chance of recurrence of the endometriotic cyst, but recurrence is still high even after taking oral contraceptive pills. Letrozole is an aromatase inhibitor. There are some preliminary reports that letrozole can cause shrinkage of endometriotic cysts and improve endometriosis-related pelvic pain by reducing oestrogen level, inflammation and stem cell recruitment that may be important in recurrence of endometriotic cyst. This is a randomized double-blinded placebo-controlled trial. The aim of this study is to assess whether taking letrozole in addition to oral contraceptive pills in the first 6 months after laparoscopic surgery (key-hole surgery) to remove the endometriotic cyst can reduce the risk of recurrence compared to oral contraceptive pills alone. The study also involves laboratory parts from a small portion of the endometriotic cyst specimens (removed during laparoscopy ovarian cystectomy) and endometrial biopsy (if the patient agrees) to assess the role of stem cells in the pathogenesis of endometriotic cysts.

Conditions

• Endometriotic Cyst of Ovary

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole 2.5mg daily for 6 months
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-12-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2022-08-04
• Last updated: 2024-05-14

Locations

5 sites across 1 country: Hong Kong