Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Women aged 18-45 years old

• Scheduled to have laparoscopic ovarian cystectomy

• Unilateral or bilateral endometrioma on pre-operative ultrasound and confirmed by histology

Locations
Other Locations
Hong Kong Special Administrative Region
Kwong Wah Hospital
NOT_YET_RECRUITING
Hong Kong
Pamela Youde Nethersole Eastern Hospital
NOT_YET_RECRUITING
Hong Kong
Princess Margaret Hospital
NOT_YET_RECRUITING
Hong Kong
Queen Elizabeth Hospital
NOT_YET_RECRUITING
Hong Kong
Queen Mary Hospital
RECRUITING
Hong Kong
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 194
Treatments
Experimental: Letrozole
They will be given letrozole 2.5mg daily on top of combined oral contraceptive (COC) pills (Microgynon 30, which contains 30mcg ethinyloestradiol and 150 mcg levonorgestrel) orally for 6 months after laparoscopic ovarian cystectomy, followed by COC pills alone subsequently as routine
Placebo_comparator: Standard treatment
They will be given placebo tablets (which will be identical to letrozole) on top of COC pills (Microgynon 30, which contains 30mcg ethinyloestradiol and 150 mcg levonorgestrel) orally for 6 months after laparoscopic ovarian cystectomy, followed by COC pills alone subsequently
Sponsors
Collaborators: Pamela Youde Nethersole Eastern Hospital, The Queen Elizabeth Hospital, Princess Margaret Hospital, Canada, Kwong Wah Hospital
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov