Using Estetrol and Drospirenone to Shrink Ovarian Endometriomas
Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
This study is testing if a hormonal treatment called Estetrol and Drospirenone can help shrink painful ovarian cysts in women with endometriosis and improve their chances of getting pregnant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05837624 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Estetrol/Drospirenone in reducing the size of ovarian endometriomas, which are cysts associated with endometriosis that can cause pain and infertility. The study aims to provide a non-surgical medical management option for patients suffering from these cysts, particularly in light of reduced surgical access due to the COVID-19 pandemic. Participants will receive hormonal treatment to alleviate symptoms and potentially improve fertility outcomes. The trial will include women aged 18 and older with endometriomas of at least 3 cm seeking hormonal therapy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with at least one ovarian endometrioma measuring 3 cm or larger who are seeking hormonal treatment.
Not a fit: Patients with allergies or contraindications to the study drug or those who have used certain hormones in the past three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for women to manage endometriomas, alleviating pain and preserving fertility.
How similar studies have performed: Other studies have shown that medical management can effectively reduce endometrioma size, making this approach promising but not entirely novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Andrew Zakhari, M.D. — McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study coordinator: Andrew Zakhari, M.D.
- Email: andrew.zakhari@mcgill.ca
- Phone: 5142288889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.