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RECRUITING
NCT05487092
NA

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2022-12-01

Completion Date

2027-06-30

Last Updated

2024-05-14

Healthy Volunteers

No

Interventions

DRUG

Letrozole

Letrozole 2.5mg daily for 6 months

OTHER

Placebo

Placebo

Locations (5)

Queen Mary Hospital

Hong Kong, Hong Kong

Kwong Wah Hospital

Hong Kong, Hong Kong

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Princess Margaret Hospital

Hong Kong, Hong Kong

Queen Elizabeth Hospital

Hong Kong, Hong Kong