Comparing Oral and Transdermal Estrogen Treatments in Women Aged 18-50 with Turner Syndrome A Randomized Phase IV Crossover Study

What this Trial Is About

Researchers are evaluating the effects of two forms of estrogen replacement therapy ERT in women with Turner syndrome TS, a genetic condition causing ovarian failure and hormone deficiencies. This phase IV randomized crossover trial aims to compare oral and transdermal estradiol treatments to determine if the two methods are equally effective by examining various markers influenced by estradiol. The study involves 50 women aged 18 to 50 years who are already receiving estrogen therapy. Participants are randomly assigned to receive either oral or transdermal 17-beta estradiol for 14 days, then switch to the other treatment after a one-week washout period, completing another 14 days of the alternate therapy. Blood samples are collected at four key points before treatment, after the first 14 days, after the washout, and after the final 14 days. This design helps assess how the body responds to each treatment method over time. Throughout the 5-week study, participants undergo blood tests to monitor estradiol-dependent markers and the bodys response to each treatment. Researchers will analyze changes in these markers to determine dose equivalence between oral and transdermal estrogen. The study also monitors safety and treatment effects, aiming to provide better guidance for hormone therapy in women with TS and contribute knowledge applicable to hormone replacement in the general population.

Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome