Novel Pharmacotherapies for Menopausal Symptoms.
Caiyun Liao, Lubna Pal
https://pubmed.ncbi.nlm.nih.gov/40773756Actively Recruiting
Phase 4
Age: 18Years +
FEMALE
ID05837624
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Led by Andrew Zakhari · Updated on 2025-04-06
21
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Estetrol/drospirenone, a combined oral contraceptive (COC), in reducing the size of ovarian endometriomas in women with endometriosis. Endometriomas, also known as "chocolate cysts," affect up to half of women with endometriosis and can cause pain, infertility, and surgical emergencies. Medical management of these cysts is an important alternative to surgery, especially during times when access to surgery is limited, such as during the COVID-19 pandemic. The study involves women aged 18 years or older who have at least one ovarian endometrioma measuring 3 cm or more and are seeking hormonal treatment. Participants will take a daily oral dose of Estetrol/drospirenone for six months. Ultrasound assessments of the cysts will be performed at the start of treatment, at 3 months, and at 6 months to monitor changes in size. The same ultrasonographer will conduct all assessments using a standardized 3-D volumetric method. During each hospital visit at baseline, 3 months, and 6 months, participants will have their weight and blood pressure measured and complete questionnaires about their endometriosis symptoms, amenorrhea occurrence, treatment compliance, and any side effects experienced. The primary outcome measure is the change in ovarian endometrioma volume at 6 months compared to baseline. Secondary measures include changes in cyst size at 3 months, symptom changes, safety, tolerability, and treatment adherence. The study is expected to run until December 2026.
CONDITIONS
Brief Title
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Has at least one ovarian endometrioma measuring 3 cm or more
- Seeking hormonal treatment for their endometrioma(s)
You will not qualify if you...
- Allergy or contraindication to the study drug
- Unable to provide informed consent
- Use of hormones such as estrogen, progestogen, androgen, GnRH, or cabergoline within the last 3 months (except for ovarian stimulation in fertility treatments)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants take a 6-month course of oral estetrol/drospirenone once daily to reduce the size of ovarian endometriomas. Ultrasound assessments, weight and blood pressure measurements, and symptom questionnaires are completed at baseline, 3 months, and 6 months.
3 visits (in-person) at baseline, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
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Research Team
A
Andrew Zakhari, M.D.
C
Cassandra Della Rocca, BSc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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