Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Not yet recruiting
McGill University Health Centre/Research Institute of the McGill University Health Centre
Phase 4
2024-07-01
Endometriosis, a chronic gynecological disorder associated with pain and infertility, is a
common condition affecting approximately one in ten women. Up to 50% of patients with
endometriosis have ovarian endometriomas (or "chocolate cysts"). These cysts directly impact
fertility and ovarian reserve (ie. ability to have children) and can cause additional
symptoms in women such as added pain, discomfort, and surgical emergencies (cyst rupture, or
more rarely twisting). While endometriomas tend to require surgical excision as a solution,
medical management with a variety of medications has been shown to be effective in reducing
their size.
Medical management (ie. medications and treatments that don't involve surgery) to reduce cyst
size can help relieve symptoms either as a long term solution, before fertility treatments,
or temporarily until surgery can be offered. Because the COVID-19 pandemic caused
significantly reduced access to surgery and resources, medical management has become
important for relief of the overburdened healthcare network.
The purpose of this study is to see how effective Estetrol/drospirenone, a combined oral
contraceptive (COC), is in the reduction of ovarian endometriomas after a 3- and 6-month
period of treatment.
This single arm interventional study will recruit women 18 years or older with an ovarian
endometrioma of at least 3cm, who are seeking a hormonal treatment for their endometrioma(s).
Consenting participants of the study will take Estetrol/drospirenone once daily, orally, for
a 6 month duration. An ultrasound assessment of ovarian endometrioma(s) will be performed
before starting the drug (0 months), and will be repeated at 3-months and 6-months time. At
each of these hospital visits (0, 3 & 6 months), participants will have their weight and
blood pressure measured, and they will complete questionnaires regarding their endometriosis
symptoms, incidence of amenorrhea, compliance and incidence of any adverse effects.
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