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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

NCT07145281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Iris Yaish, MD · Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv Sourasky Medical Center, Tel Aviv

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2024-11-10
Completion
2024-11-10

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145281 on ClinicalTrials.gov