About this trial
This 5-week, phase IV randomized crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The objective is to establish the equipotency between the two estradiol regimens by evaluating various estradiol-dependent surrogate markers. The study involves 50 women with TS, aged 18-50 years, who are randomized to receive either oral or transdermal ERT for 14 days, followed by a crossover to the alternate treatment for another 14 days, with a one-week washout period in between. Blood tests are conducted at baseline, after the first 14 days of treatment, after the washout period, and after the final 14 days of treatment. The investigators anticipate that this study will provide clinicians with a better understanding of ERT in treating women with TS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of TS regardless of karyotype
Age 18-50 years
Already receiving estrogen treatment
Disqualifiers
Active systemic chronic diseases
Known or suspected breast cancer
Known or suspected estradiol-dependent tumors (endometrial cancer or similar)
Untreated endometrial hyperplasia
Trial design
Crossover
Treatments tested in this trial
17-beta estradiol
DrugTreatment with orally administered estrogen for 14 days
17-beta estradiol
DrugTreatment with transdermally administered estrogen for 14 days
Treatment groups
Trial outcomes
Primary outcomes
Equipotency
Levels of luthenizing hormone and follicle stimulating hormone are measured at different doses
Sponsors and contacts
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Aarhus University Hospital
Lead sponsor
University of Aarhus
Collaborator