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Search / Trial NCT05837624

Estetrol/Drospirenone to Reduce the Average Size of Endometriomas

Launched by ANDREW ZAKHARI · Apr 27, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Estetrol/Drospirenone Nextstellis Endometriosis Volume Reduction Ultrasound Estetrol Drospirenone

ClinConnect Summary

This clinical trial is studying a medication called Estetrol/drospirenone to see if it can help reduce the size of ovarian endometriomas, which are cysts that can cause pain and affect fertility in women with endometriosis. The trial is open to women aged 18 and older who have at least one endometrioma that is 3 centimeters or larger and are looking for hormonal treatment. Participants will take the medication daily for six months while their symptoms and cysts are monitored through ultrasounds and questionnaires.

If you join this study, you will visit the hospital three times: at the start, and then again at three and six months. During these visits, healthcare providers will check your weight and blood pressure and ask about your experience with the treatment, including any side effects. This trial is particularly important as it offers a non-surgical option for managing endometriomas, especially during times when surgeries may be limited.

Gender

FEMALE

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

About Andrew Zakhari

Andrew Zakhari is a dedicated clinical trial sponsor with a focus on advancing medical research and innovation. With a commitment to enhancing patient care, Mr. Zakhari collaborates with leading researchers and healthcare institutions to design and implement rigorous clinical trials across various therapeutic areas. His expertise in regulatory compliance, project management, and data analysis ensures that each study is conducted with the highest ethical standards and scientific integrity. By fostering partnerships and prioritizing patient safety, Andrew Zakhari aims to contribute significantly to the development of new treatments and therapies that address unmet medical needs.

Locations

Montreal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Andrew Zakhari, M.D.

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported