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

NCT07204093 | Active Not Recruiting

• 2 other identifiers: 0021423-UTAEDIUMVITAE
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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-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

Outcome Measures

Primary Outcomes (1)

• Patients' statisfaction

  Therapy satisfaction will be assessed by means of a 5-level Likert scale (very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied). Women expressing the judgement 'very satisfied' and 'satisfied' will be considered to be globally satisfied, similarly to reported in the study on which the calculation of the sample size is based. The outcome will be dichotomised (very satisfied + satisfied versus neither satisfied nor dissatisfied + dissatisfied + very dissatisfied). The level of statisfaction in the two groups will be compared as the proportion of satisfied women in each treatment group, reported as frequencies and percentages and analyzed accordingly.

  This outcome will be evaluated after at least 6 months of treatment

Secondary Outcomes (11)

• Therapeutic efficacy - symptoms control (NRS)

  This outcome will be evaluated after at least 6 months of treatment

• Therapeutic efficacy - symptoms control (use of analgesics)

  This outcome will be evaluated after at least 6 months of treatment

• Therapeutic efficacy - ovulation suppression

  This outcome will be evaluated after at least 6 months of treatment

• Therapeutic efficacy - amenorrhea achievement and bleeding pattern

  This outcome will be evaluated after at least 6 months of treatment

• Global Impression of Change

  This outcome will be evaluated after at least 6 months of treatment

Study Arms (1)

Women with endometriosis undergoing medical management

This cohort will include women of reproductive age with a confirmed diagnosis of endometriosis, either by laparoscopy/histology or by validated imaging techniques (e.g., transvaginal ultrasound, MRI).

Drug: Drospirenone 4 mg orally; Drug: Dienogest 2 mg orally

Interventions

Drospirenone 4 mg orally DRUG

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

Also known as: Slinda

Women with endometriosis undergoing medical management

Dienogest 2 mg orally DRUG

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

Also known as: Visanne, Dienogest, Zafrilla

Women with endometriosis undergoing medical management

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women with endometriosis referred to the endometriosis outpatient clinic of the Gynaecology SC of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico in Milan between October 2024 and September 2025 will be included in the study. The diagnosis of endometriosis is made on the basis of the combination of symptomatology + gynaecological examination, transvaginal/transrectal ultrasound or previous surgical visualisation of the disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Gynecology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Endometriosis

Interventions

drospirenone; dienogest

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: October 2, 2025
• Study Start: August 11, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-07

Locations

IT (1)