Endometriotic Cyst of Ovary study: Letrozole
Official title Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy
ClinicalTrials.gov ID: NCT05487092
What this study is testing
What is Letrozole?
Letrozole is an investigational oral medicine being studied to see if it helps prevent the return of endometriotic cysts after surgery. It is designed to lower estrogen levels in the body, which may help reduce inflammation and the growth of endometriosis tissue.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding letrozole to oral contraceptive pills for the first six months after surgery reduces the risk of the endometriotic cyst returning, compared with pills alone.
- Who it's for
- Women who have had a laparoscopic surgery to remove an endometriotic cyst and are willing to take medication after the operation.
- What's involved
- Participants will take either letrozole or a placebo along with their usual birth control pills for six months. They will also have a few small lab tests on tissue removed during surgery and, if they agree, a biopsy of the lining of the uterus.
- Time commitment
- The study lasts about six months of medication, with follow‑up visits and tests scheduled during that time.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Women aged 18-45 years old
- Scheduled to have laparoscopic ovarian cystectomy
- Unilateral or bilateral endometrioma on pre-operative ultrasound and confirmed by histology
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- Planning to get pregnant in the coming 1 year
- Refusal to join the study
The study team makes the final eligibility decision.
Where it is enrolling
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hong Kong, Hong Kong. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.