Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

Last updated: May 13, 2024
Sponsor: The University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

Letrozole

Placebo

Clinical Study ID

NCT05487092
UW21-556
  • Ages 18-45
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 18-45 years old

  • Scheduled to have laparoscopic ovarian cystectomy

  • Unilateral or bilateral endometrioma on pre-operative ultrasound and confirmed byhistology

Exclusion

Exclusion Criteria:

  • Use of long-acting hormonal therapy in the 3 months before inclusion in the study

  • Histological report of laparoscopic ovarian cystectomy showed atypical endometrioma

  • Complex surgery including resection of deep infiltrating disease, bowel resection orhysterectomy

  • Incomplete excision of endometrioma/ incision or drainage rather than ovariancystectomy

  • Suspicion of malignancy

  • Contraindications to combined oral contraceptive pills, including: uncontrolledhypertension (systolic > 160mmHg or diastolic > 100mmHg), diabetes with retinopathy/nephropathy/ neuropathy, current or past history of venous thromboembolism, ischemicheart disease, history of cerebrovascular accident, migraine with aura, severe liverdisease, oestrogen-sensitive cancers, undiagnosed abnormal uterine bleeding, smokers (> 15 cigarettes/day) aged 35 years or above, or having body mass index >=35 kg/m2

  • Planning to get pregnant in the coming 1 year

  • Refusal to join the study

Study Design

Total Participants: 194
Treatment Group(s): 2
Primary Treatment: Letrozole
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
June 30, 2027

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