Recruiting

Estetrol/Drospirenone

Sponsor:

Andrew Zakhari

Code:

NCT05837624

Conditions

Ovarian Endometrioma

Endometrioma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Estetrol/Drospirenone

Study Details

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.

Conditions

Ovarian Endometrioma

Endometrioma

Study ID

NCT05837624

Start date

Dec 3, 2024

Status verified date

Feb, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Women with an ovarian endometrioma who will take drospirenone / estetrol

Women 18 years of age or older with endometriosis who have at least one ovarian endometrioma, of at least 3 cm in diameter, who will take oral Drospirenone / Estetrol treatment for 6 months

Interventions

Estetrol/Drospirenone

6-month course of oral estetrol/drospirenone (15 mg estetrol monohydrate / 3 mg drospirenone) once daily for the study duration

Primary outcome measure

  • Change in ovarian endometrioma volume at 6-months (from baseline) [ Time Frame: pre-study, 6-months of treatment ]

Central Contacts and Locations

Central contacts

Cassandra Della Rocca, BSc.

cassandra.dellarocca@rimuhc.ca

Locations

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Principal Investigator:

Andrew Zakhari, M.D.

More Information

Sponsor

Andrew Zakhari

Last update posted

Apr 6, 2025

Last verified

Feb, 2025

Keywords

  • Estetrol/drospirenone
  • Nextstellis
  • Endometriosis
  • volume reduction
  • ultrasound
  • Estetrol-drospirenone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew Zakhari on 2025-04-06.