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Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

NCT05487092 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2024-05-14

No results posted yet for this study

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

DRUG

Letrozole

Letrozole 2.5mg daily for 6 months

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Pamela Youde Nethersole Eastern Hospital

    collaborator OTHER

  • The Queen Elizabeth Hospital

    collaborator OTHER

  • Kwong Wah Hospital

    collaborator OTHER

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05487092 on ClinicalTrials.gov