NCT05837624 Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
| NCT ID | NCT05837624 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Andrew Zakhari |
| Condition | Ovarian Endometrioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 21 participants in total. It began in 2024-12-03 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Equal to or greater than 18 years old * Has at least one ovarian endometrioma, of at least 3 cm * Seeking a hormonal treatment for their endometrioma(s) Exclusion criteria: * Any allergy or contraindication to the study drug * Inability to provide informed consent * Any hormone use, from the following list, within last 3 months (excluding hormones used for ovarian stimulation for fertility treatments): Estrogen (agonist or antagonist), Progestogen (agonist or antagonist), Androgen (agonist or antagonist), GnRH (agonist or antagonist), Cabergoline
Contact & Investigator
Andrew Zakhari, M.D.
PRINCIPAL INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT05837624 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Endometrioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05837624 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05837624 currently recruiting?
Yes, NCT05837624 is actively recruiting participants. Contact the research team at andrew.zakhari@mcgill.ca for enrollment information.
Where is the NCT05837624 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05837624 clinical trial?
NCT05837624 is sponsored by Andrew Zakhari. The principal investigator is Andrew Zakhari, M.D. at McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 21 participants.