Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT07204093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis
Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Organization:
Study Overview
Official Title:
Transdermally Applied Estradiol Delivery In Ultra-Safe Medications Valuable In Treatment Against Endometriosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAEDIUMVITAE
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.
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.
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 adhesions, often resulting in pelvic pain, dysmenorrhea, dyspareunia, infertility, and impaired quality of life. The condition affects an estimated 6-10% of women of reproductive age, with peak prevalence between 25 and 35 years, making it one of the most common gynecological diseases with significant social and economic impact.
Available treatments for endometriosis are symptomatic rather than curative. Medical management is considered the cornerstone of therapy, especially in women who are not seeking immediate pregnancy. Current guidelines recommend progestins as first-line treatment due to their proven efficacy in suppressing endometriosis-associated pain and their favorable safety and tolerability profile. However, because therapy is usually long-term until menopause and continuous, optimal regimens must combine efficacy with good tolerability and sustained patient satisfaction.
Dienogest is an established fourth-generation progestin widely used in endometriosis management, with well-documented efficacy and safety. Drospirenone, another fourth-generation progestin, combines progestogenic, anti-androgenic, and anti-mineralocorticoid activities. Although marketed primarily as a contraceptive, drospirenone has shown promising results in controlling endometriosis symptoms and improving patient-reported outcomes.
Progestin-only regimens may lead to hypoestrogenic adverse effects, including vaginal dryness, mood disturbances, reduced libido, irregular bleeding, and bone loss. For this reason, the addition of natural estradiol is considered advantageous, as it may prevent atrophic changes, support bone metabolism, and improve overall quality of life. Transdermal estradiol, in particular, avoids hepatic first-pass metabolism, does not induce prothrombotic liver factors, and is associated with a lower risk of thromboembolic events compared with ethinyl estradiol.
This observational study is designed to directly compare two therapeutic strategies for women with endometriosis: Dienogest + transdermal estradiol or Drospirenone + transdermal estradiol.
The primary endpoint is patient satisfaction after 6 months of treatment, reflecting the central importance of patient-centered outcomes in a chronic disease that impacts multiple aspects of daily life. Secondary endpoints include sexual function, psychological well-being, and health-related quality of life, assessed with validated questionnaires.
By comparing two modern progestin-based regimens combined with natural estradiol, this study aims to generate evidence that will help clinicians tailor hormonal therapy to improve not only symptom control but also the long-term well-being and quality of life of women with endometriosis.
Available treatments for endometriosis are symptomatic rather than curative. Medical management is considered the cornerstone of therapy, especially in women who are not seeking immediate pregnancy. Current guidelines recommend progestins as first-line treatment due to their proven efficacy in suppressing endometriosis-associated pain and their favorable safety and tolerability profile. However, because therapy is usually long-term until menopause and continuous, optimal regimens must combine efficacy with good tolerability and sustained patient satisfaction.
Dienogest is an established fourth-generation progestin widely used in endometriosis management, with well-documented efficacy and safety. Drospirenone, another fourth-generation progestin, combines progestogenic, anti-androgenic, and anti-mineralocorticoid activities. Although marketed primarily as a contraceptive, drospirenone has shown promising results in controlling endometriosis symptoms and improving patient-reported outcomes.
Progestin-only regimens may lead to hypoestrogenic adverse effects, including vaginal dryness, mood disturbances, reduced libido, irregular bleeding, and bone loss. For this reason, the addition of natural estradiol is considered advantageous, as it may prevent atrophic changes, support bone metabolism, and improve overall quality of life. Transdermal estradiol, in particular, avoids hepatic first-pass metabolism, does not induce prothrombotic liver factors, and is associated with a lower risk of thromboembolic events compared with ethinyl estradiol.
This observational study is designed to directly compare two therapeutic strategies for women with endometriosis: Dienogest + transdermal estradiol or Drospirenone + transdermal estradiol.
The primary endpoint is patient satisfaction after 6 months of treatment, reflecting the central importance of patient-centered outcomes in a chronic disease that impacts multiple aspects of daily life. Secondary endpoints include sexual function, psychological well-being, and health-related quality of life, assessed with validated questionnaires.
By comparing two modern progestin-based regimens combined with natural estradiol, this study aims to generate evidence that will help clinicians tailor hormonal therapy to improve not only symptom control but also the long-term well-being and quality of life of women with endometriosis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TAEDIUMVITAE | OTHER | Comitato Etico Territoriale Lombardia 3 | View |