NCT05487092Recruiting
Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy
Source: ClinicalTrials.gov · Last updated 14 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 194 (estimated)
- First submitted
- 2 Aug 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- The University of Hong Kong
- Diseases
- Endometriosis
- NCT number
- NCT05487092
What you commit to
- Study type: Interventional
- Planned participants: 194
- From 1 Dec 2022 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of long-acting hormonal therapy in the 3 months before inclusion in the study
Other illness
- Complex surgery including resection of deep infiltrating disease, bowel resection or hysterectomy
- Suspicion of malignancy
Age
- 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
Other
- Histological report of laparoscopic ovarian cystectomy showed atypical endometrioma
- Incomplete excision of endometrioma/ incision or drainage rather than ovarian cystectomy
- Planning to get pregnant in the coming 1 year
- Refusal to join the study
Who the study is looking for
- Women aged 18-45 years old
- Scheduled to have laparoscopic ovarian cystectomy
- Unilateral or bilateral endometrioma on pre-operative ultrasound and confirmed by histology
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Not yet recruiting |
| Kwong Wah Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Not yet recruiting |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Not yet recruiting |
| Pamela Youde Nethersole Eastern Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.