Stopstudy
Phase 1
Recruiting
- Conditions
- Transgender women using long-term gender-affirming hormone therapyTherapeutic area: Psychiatry and Psychology [F] - Psychological Phenomena [F02]Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-505143-39-00
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Age > 54 years, Use of gender-affirming hormone therapy (GHT) for at least 10 years, Current use of GHT, Currently in treatment at the Center of Expertise on Gender Dysphoria: last clinical appointment <3 years ago, Undergone gonadectomy (i.e., vaginoplasty or orchiectomy)
Exclusion Criteria
Insufficient understanding of the Dutch language
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Explore changes in cardiovascular risk determinants after stopping estradiol therapy in older long-term gender-affirming hormone therapy (GHT) receiving transgender women for 12 weeks and after restarting estradiol therapy again for 12 weeks.;Secondary Objective: Explore the impact of stopping and restarting estradiol therapy on psychological wellbeing, quality of life, sleep, and body image.;Primary end point(s): cardiovascular risk determinants: height, weight, body mass index (BMI), bioelectrical impedance analysis, blood pressure, heart rate, and laboratory measures including total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and haematocrit
- Secondary Outcome Measures
Name Time Method