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Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis

NCT07204093 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2025-10-02

No results posted yet for this study

Summary

Endometriosis is a chronic, estrogen-dependent disease affecting women of reproductive age, associated with pelvic pain, infertility, and reduced quality of life. Progestins are the standard first-line therapy, but long-term treatment requires well-tolerated regimens that balance efficacy with patient satisfaction.

This study will compare two combinations of progestins with natural transdermal estradiol-dienogest versus drospirenone-to evaluate which regimen provides greater patient satisfaction after 6 months of therapy.

Conditions

  • Endometriosis

Interventions

DRUG

Drospirenone 4 mg orally

Daily oral administration of Drospirenone 4 mg + Transdermal estradiol; continuous administration for at least 6 months.

DRUG

Dienogest 2 mg orally

Daily oral administration of Dienogest 2 mg + Transdermal estradiol; continuous administration for at least 6 months.

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07204093 on ClinicalTrials.gov