Letrozole vs Danazol for Endometriosis-Related Pain: Randomized Trial (NCT07183787) | Clinical Trial Compass
CompletedPhase 2
Letrozole vs Danazol for Endometriosis-Related Pain: Randomized Trial
Pakistan60 participantsStarted 2019-04-10
Plain-language summary
Background:
Endometriosis is a chronic gynecological condition defined by the ectopic presence of endometrial glands and stroma outside the uterine cavity, most commonly diagnosed via laparoscopy. While its exact etiology remains uncertain, a positive family history is considered a significant risk factor. Danazol has historically demonstrated efficacy in alleviating endometriosis-related pain, while letrozole, primarily used in neoadjuvant settings, has recently emerged as a promising alternative. This study aimed to compare the mean reduction in pain scores between letrozole and danazol in women with laparoscopically confirmed endometriosis.
Objective:
To compare the efficacy of letrozole versus danazol in reducing pain scores among women diagnosed with endometriosis.
Material \& Methods:
Study Design: Randomized control trial Setting: Department of Obstetrics \& Gynaecology, Sharif Medical and Dental Hospital
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged 18-45 years
Surgically or clinically diagnosed endometriosis
Moderate to severe pelvic pain (NRS ≥ 4 for at least 3 months)
Willing to use effective contraception during the study
Able to provide informed consent
Exclusion Criteria:
* Pregnant or breastfeeding
Severe hepatic disease, thromboembolic disorder, or contraindication to study drugs
Use of hormonal therapy within the last 8 weeks
Known hypersensitivity to Letrozole or Danazol
Participation in another clinical trial within the last 3 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pelvic pain severity (0-10 Numeric Rating Scale)