Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05487092

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kwong Wah Hospital, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18-45 years old
  • Scheduled to have laparoscopic ovarian cystectomy
  • Unilateral or bilateral endometrioma on pre-operative ultrasound and confirmed by histology

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 or hysterectomy
  • Incomplete excision of endometrioma/ incision or drainage rather than ovarian cystectomy
  • Suspicion of malignancy
  • Contraindications to combined oral contraceptive pills, including: uncontrolled hypertension (systolic > 160mmHg or diastolic > 100mmHg), diabetes with retinopathy/ nephropathy/ neuropathy, current or past history of venous thromboembolism, ischemic heart disease, history of cerebrovascular accident, migraine with aura, severe liver disease, 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

Treatment and study plan

letrozole

Drug

Letrozole 2.5mg daily for 6 months

Placebo

Other

Placebo

Primary outcomes

  1. Recurrence of endometrioma

    Time frame: 12 months

    the presence of ovarian cysts with the typical sonographic criteria of endometriomas and a diameter of ≥30 mm after previous complete ovarian cystectomy, to be measured by a transvaginal or transrectal ultrasound transducer

Secondary outcomes

  1. Endometriosis Health Profile Questionnaire (EHP-30) score

    Time frame: 6 months, 12 months, 24 months

    a validated disease-specific health related quality of life patient self-reported scale for endometriosis used to measure the effects that endometriosis can have on the women's lives and the effectiveness of medical and surgical therapies for endometriosis on their quality of life

  2. Non-menstrual pelvic pain (chronic pelvic pain, deep dyspareunia) and dysmenorrhoea measured by a 10cm visual analogue pain scale (VAS)

    Time frame: 6 months, 12 months, 24 months

    0-100

  3. Menstrual regularity

    Time frame: 6 months, 12 months, 24 months

    menstrual chart

  4. Use of additional analgesics

    Time frame: 6 months, 12 months, 24 months

  5. Side effects/ adverse events

    Time frame: 6 months, 12 months, 24 months

    Number of women with side effects/ adverse events

  6. Need for further surgery for endometriosis

    Time frame: 6 months, 12 months, 24 months

    Number of women who required further surgery for endometriosis

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Kwong Wah Hospital
  • Pamela Youde Nethersole Eastern Hospital
  • Princess Margaret Hospital, Canada
  • The Queen Elizabeth Hospital

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 4, 2022
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.