Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT05487092

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

Led by The University of Hong Kong · Updated on 2024-05-14

194

Participants Needed

5

Research Sites

238 weeks

Total Duration

On this page

Sponsors

T

The University of Hong Kong

Lead Sponsor

P

Pamela Youde Nethersole Eastern Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18-45 years old
  • Scheduled to have laparoscopic ovarian cystectomy
  • Unilateral or bilateral endometrioma confirmed by ultrasound and histology
Not Eligible

You will not qualify if you...

  • Use of long-acting hormonal therapy in the 3 months before study
  • Atypical endometrioma found in histology after cystectomy
  • Complex surgery involving deep disease resection, bowel resection, or hysterectomy
  • Incomplete cyst removal or cyst drainage instead of cystectomy
  • Suspicion of cancer
  • Contraindications to combined oral contraceptive pills including uncontrolled hypertension, diabetes with complications, blood clots, heart disease, stroke history, migraine with aura, severe liver disease, estrogen-sensitive cancers, unexplained abnormal uterine bleeding, smokers over 15 cigarettes/day aged 35 or above, or BMI 35 or higher
  • Planning pregnancy within 1 year
  • Refusal to participate in the study

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Queen Mary Hospital

Hong Kong, Hong Kong, 000000

Actively Recruiting

2

Kwong Wah Hospital

Hong Kong, Hong Kong

Not Yet Recruiting

3

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Not Yet Recruiting

4

Princess Margaret Hospital

Hong Kong, Hong Kong

Not Yet Recruiting

5

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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