Comparing Oral and Transdermal Estrogen Replacement Therapy in Women with Turner Syndrome Aged 18 to 50 Years

What this Trial Is About

Researchers are comparing the effects of oral versus transdermal estrogen replacement therapy ERT in women with Turner syndrome TS, a genetic condition causing ovarian failure and estrogen deficiency. This 14-month, phase IV randomized controlled crossover trial aims to better understand endocrine, metabolic, cardiovascular, and thromboembolic risks after a washout period without estrogen treatment. The study involves 50 women with TS aged 18-50 years and 50 healthy controls to clarify long-term effects of ERT through different administration routes. Participants with TS will stop any current estrogen treatment for one month before randomization, then receive either oral or transdermal estrogen therapy for six months, followed by a one-month washout and crossover to the other treatment for another six months. The control group of healthy women will not receive treatment but will undergo assessments for comparison. Treatments studied include oral estradiol Estrofem and transdermal estradiol Divigel. During the study, participants will undergo blood and urine tests, 24-hour blood pressure monitoring, DEXA scans, muscle strength and function tests, MRI muscle imaging, and quality of life questionnaires. Assessments occur at baseline, after the washout period, and after each six-month treatment phase. The main outcomes measured include blood values, cardiovascular status, muscle quality, and oxygen uptake. Safety and quality of life will also be monitored. The study aims to improve hormone replacement recommendations for TS patients.

Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome