Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

Launched by THE UNIVERSITY OF HONG KONG · Aug 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called letrozole can help prevent the recurrence of endometriomas (which are cysts caused by endometriosis) after surgery to remove them. Endometriosis affects many women and can cause pain and other symptoms. While surgery is a common treatment, these cysts can come back in a significant number of cases. In this study, researchers want to see if taking letrozole along with oral contraceptive pills for the first six months after surgery can lower the chances of the cysts returning compared to just using the contraceptive pills alone.

To participate in this trial, women aged 18 to 45 who are scheduled for laparoscopic ovarian cyst surgery may be eligible. Those who have had certain types of hormonal therapy recently or have specific health issues may not qualify. Participants can expect to take either letrozole or a placebo (a harmless pill with no active ingredients) alongside their contraceptive pills. The study will also involve some lab tests on tissue samples to better understand how endometriomas develop. Overall, this trial aims to find a more effective way to help women stay cyst-free after surgery.

Gender

FEMALE

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