NCT07204093Active, not recruiting
Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis
Transdermally Applied Estradiol Delivery In Ultra-Safe Medications Valuable In Treatment Against Endometriosis
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 138 (estimated)
- First submitted
- 8 Sept 2025
- Start date
- 11 Aug 2025
- Primary completion date
- Feb 2026
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Diseases
- Endometriosis
- NCT number
- NCT07204093
What you commit to
- Study type: Observational
- Planned participants: 138
- From 11 Aug 2025 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gynecology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.