Using Letrozole to Prevent Endometrioma Recurrence After Surgery
Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy
This study is testing if the medication Letrozole can help prevent endometriomas from coming back after surgery in women aged 18-45.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 5 sites (Hong Kong and 4 other locations) |
| Trial ID | NCT05487092 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Letrozole, an aromatase inhibitor, in preventing the recurrence of endometriomas following laparoscopic ovarian cystectomy. Endometriosis, affecting a significant percentage of women, often leads to the formation of endometriotic cysts, which can recur after surgical removal. The study aims to determine if Letrozole can reduce the recurrence rate compared to a placebo, potentially offering a new postoperative hormonal therapy option. Participants will be women aged 18-45 scheduled for surgery, and they will receive either Letrozole or a placebo for a specified duration post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-45 who are scheduled for laparoscopic ovarian cystectomy due to endometriomas.
Not a fit: Patients who have contraindications to combined oral contraceptive pills or those with atypical endometriomas or malignancy suspicion may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of endometriomas and improve the quality of life for women suffering from endometriosis.
How similar studies have performed: Preliminary reports suggest that similar approaches using Letrozole have shown promise, but this specific application in preventing endometrioma recurrence is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong and 4 other locations
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
- Kwong Wah Hospital — Hong Kong, Hong Kong (Not_yet_recruiting)
- Pamela Youde Nethersole Eastern Hospital — Hong Kong, Hong Kong (Not_yet_recruiting)
- Princess Margaret Hospital — Hong Kong, Hong Kong (Not_yet_recruiting)
- Queen Elizabeth Hospital — Hong Kong, Hong Kong (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.