Study of EstetrolDrospirenone Oral Treatment to Reduce the Size of Ovarian Endometriomas in Women

What this Trial Is About

Researchers are evaluating the effectiveness of Estetroldrospirenone, 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 Estetroldrospirenone 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.

Estetrol/Drospirenone to Reduce the Average Size of Endometriomas