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

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 10, 2022

Primary Completion Date

November 10, 2024

Study Completion Date

November 10, 2024

Conditions
Gender Dysphoria, AdultBlood CoagulationCoagulation FactorsTransgender Persons, M01.777.500HemostasisTransgender 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."

Trial Locations (1)

Unknown

Tel Aviv Sourasky Medical Center - Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv

All Listed Sponsors
lead

Tel-Aviv Sourasky Medical Center

OTHER_GOV