Trials / Completed
CompletedNCT07145281
Comparing the Effects of Sublingual Estradiol Treatment Versus Oral Estradiol With Cyproterone Acetate (CPA) Treatment on The Coagulation System in Transgender Women: A Prospective, Controlled Cohort Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Tel-Aviv Sourasky Medical Center · Other Government
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The goal of this clinical trial is to learn about the effects of different routes of estradiol administration on blood clotting in transgender women starting gender-affirming hormone therapy. The main questions it aims to answer are: Does sublingual estradiol reduce free Protein S levels compared to oral estradiol with cyproterone acetate? Does sublingual estradiol accelerate activation of the clotting system, as measured by thrombin generation? Researchers will compare sublingual estradiol to oral estradiol plus cyproterone acetate to see if the way estradiol is taken changes blood clotting risk. Participants will: Take either sublingual estradiol (2 mg daily in divided doses) or oral estradiol (2 mg daily) with cyproterone acetate (10 mg daily) for 6 months Provide blood samples at baseline and after 6 months to measure hormone levels and clotting factors Attend clinic visits for monitoring, including safety checks and routine laboratory tests
Conditions
- Gender Dysphoria, Adult
- Blood Coagulation
- Coagulation Factors
- Transgender Persons, M01.777.500
- Hemostasis
- Transgender Women
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Estradiol (E2) | Participants receive estradiol 2 mg/day. In the experimental arm, estradiol is administered sublingually in four divided doses (0.5 mg each). In the active comparator arm, estradiol is administered orally, in combination with cyproterone acetate, for 6 months. All participants are treatment-naive. |
| DRUG | Cyproterone Acetate (Androcur, BAY94-8367) | Participants in the active comparator arm receive cyproterone acetate (CPA) 10 mg orally, once daily, in combination with oral estradiol, for 6 months. All participants are treatment-naive. |
Timeline
- Start date
- 2022-11-10
- Primary completion
- 2024-11-10
- Completion
- 2024-11-10
- First posted
- 2025-08-28
- Last updated
- 2025-08-28
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT07145281. Inclusion in this directory is not an endorsement.