Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Letrozole, Placebo.
- Who it may be relevant to
- Registry conditions: Endometriotic Cyst of Ovary. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Letrozole
Letrozole 2.5mg daily for 6 months - Other Placebo
Placebo
Primary outcome measures
- Recurrence of endometrioma [Time frame: 12 months]
Secondary outcome measures (6)
- Endometriosis Health Profile Questionnaire (EHP-30) score [Time frame: 6 months, 12 months, 24 months]
- 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]
- Menstrual regularity [Time frame: 6 months, 12 months, 24 months]
- Use of additional analgesics [Time frame: 6 months, 12 months, 24 months]
- Side effects/ adverse events [Time frame: 6 months, 12 months, 24 months]
- Need for further surgery for endometriosis [Time frame: 6 months, 12 months, 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Hong Kong · 5 centers
- Queen Mary Hospital — Hong Kong
- Kwong Wah Hospital — Hong Kong
- Pamela Youde Nethersole Eastern Hospital — Hong Kong
- Princess Margaret Hospital — Hong Kong
- Queen Elizabeth Hospital — Hong Kong
Identifiers
NCT: NCT05487092 · UW21-556