Status:
ACTIVE_NOT_RECRUITING
Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Endometriosis
Eligibility:
FEMALE
18-40 years
Brief 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-lin...
Detailed Description
Endometriosis is a chronic, estrogen-dependent disorder characterized by the presence of endometrial tissue outside the uterine cavity. This ectopic tissue induces chronic inflammation, fibrosis, and ...
Eligibility Criteria
Inclusion
- women who have been on combination therapy for at least 6 months with progestin and transdermal natural oestrogen (Dienogest + transdermal oestradiol or Drospirenone + transdermal oestradiol);
- women who have performed follow-up at least 6 months after the start of treatment and for whom data on the primary endpoint of the study (treatment satisfaction) are available.
Exclusion
- absence of surgical diagnosis or imaging indicative of endometriosis or adenomyosis;
- women who have taken GnRH analogue therapy within 6 months prior to treatment with dienogest + transdermal oestradiol vs. drospirenone + transdermal oestradiol
- women who have taken only progestogen therapy without transdermal oestradiol or with contraindications to oestrogen use;
- women who received surgical indications during the treatment period, including obstructive uropathy or symptomatic bowel stricture; evidence of complex ovarian cysts or ovarian endometriomas with a diameter greater than 5 cm on transvaginal ultrasound.
Key Trial Info
Start Date :
August 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT07204093
Start Date
August 11 2025
End Date
February 1 2026
Last Update
October 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gynecology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122