Stopstudy

Start 23 Feb 2024 · End 29 Sep 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol NL81591.018.22

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ended

Participants planned 30

Countries 1

Sites 1

Transgender women using long-term gender-affirming hormone therapy

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.

Key facts

Sponsor: Amsterdam UMC
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Female
Therapeutic area: Psychiatry and Psychology [F] - Psychological Phenomena [F02], Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 23 Feb 2024 → 29 Sep 2025
Decision date (initial): 2023-09-15
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No
Funding sources: Amsterdam UMC PhD scholarship to drs. J.O. van Heesewijk

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

Secondary objectives 1

Explore the impact of stopping and restarting estradiol therapy on psychological wellbeing, quality of life, sleep, and body image.

Conditions and MedDRA coding

Transgender women using long-term gender-affirming hormone therapy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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 1

Insufficient understanding of the Dutch language

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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 endpoints 5

grip strength and varying determinants of general wellbeing, including Satisfaction with Life Scale, Subjective Happiness Scale, PROMIS Emotional Distress – Anxiety – Short Form 8a, PROMIS Emotional Distress – Depression – Short Form 8b, World Health Organization Quality of Life Assessment (WHO-QoL BREF), Pittsburgh sleep quality index, Body Image Scale
The hormonal symptoms questionnaire including an extra question about perceived skin changes and questions regarding an overall evaluation of perceived changes and experiences due to stopping/restarting GHT
General information including age, type and dose of estradiol therapy, surgical status (i.e., type of gonadectomy), cardiovascular morbidity, and medication
Lifestyle factors (i.e., smoking, alcohol consumption, physical activity by means of Baecke Activity Questionnaire) and laboratory measures including 17-beta estradiol (pmol/l), luteinizing hormone (E/l), follicle stimulating hormone (E/l), testosterone (nmol/l)
Three extra blood samples per visit for storage in the established gender biobank