Estetrol/Drospirenone to Reduce the Average Size of Endometriomas

NCT05837624 | Recruiting Phase 4

• 1 other identifier: 2024-9147
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in ovarian endometrioma volume at 6-months (from baseline)

  Endometrioma volume will be assessed by the same ultrasonographer (Dr. DB Nguyen) at each hospital visit, using a standardized technique, with 3-dimensional volumetric assessment.

  pre-study, 6-months of treatment

Secondary Outcomes (9)

• Change in endometrioma volume at 3-months (from baseline)

  pre-study, 3-months of treatment

• change in endometrioma maximal diameter at 6-months (from baseline)

  pre-study, 6-months of treatment

• change in endometrioma maximal diameter at 3-months (from baseline)

  pre-study, 3-months of treatment

• Incidence of amenorrhea

  pre-study, 3-months of treatment, 6-months of treatment

• Change in patient reported endometriosis symptoms

  pre-study, 3-months of treatment, 6-months of treatment

Study Arms (1)

Women with an ovarian endometrioma who will take drospirenone / estetrol

EXPERIMENTAL

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

Drug: Estetrol/Drospirenone

Interventions

Estetrol/Drospirenone DRUG

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

Women with an ovarian endometrioma who will take drospirenone / estetrol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew Zakhari: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (1)

• Liao C, Pal L. Novel Pharmacotherapies for Menopausal Symptoms. Obstet Gynecol. 2025 Oct 1;146(4):473-486. doi: 10.1097/AOG.0000000000006025. Epub 2025 Aug 7.

  PMID: 40773756 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

drospirenone and estetrol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Andrew Zakhari, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Zakhari, M.D.

CONTACT

5142288889; andrew.zakhari@mcgill.ca

Cassandra Della Rocca, BSc.

CONTACT

cassandra.dellarocca@rimuhc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Andrew Zakhari, MD, FRCSC, MGSC

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 1, 2023
• Study Start: December 3, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)