About this trial
This 14-month, phase IV, randomized controlled crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The study's objectives are to clarify endocrine, metabolic, cardiovascular, and thromboembolic risk factors in TS after a wash-out period without estrogen (E2) treatment; compare the effects of oral versus transdermal (TD) ERT regimens; and examine the long-term effects of E2 administration via these two routes. The study involves 50 TS women aged 18-50 years and 50 control participants. TS participants are randomized to receive either oral or TD ERT for six months, followed by crossover to the alternate treatment for another six months. Prior to randomization, any existing ERT will be discontinued for a 1-month washout period. A second 1-month washout period will occur between the two 6-month treatment phases. Laboratory analyses and clinical investigations are performed after the first wash-out period, after the first six months of treatment, and after the last six months of treatment. We anticipate that this study may provide a basis for new and improved recommendations for sex hormone replacement therapy in TS.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of TS regardless of karyotype
Age 18-50 years
Already receiving estrogen treatment
Female
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 6 months
17-beta estradiol
DrugTreatment with transdermally administered estrogen for 6 months
Treatment groups
Trial outcomes
Primary outcomes
Blood test values
Changes in blood test values of follicle stimulating hormone and luthenizing hormone from baseline
Blood test values
Changes in blood test values of estradiol from baseline
Dual energy X-ray absorptiometry
Changes in body composition and bone mineral density
Cardiovascular status
Changes in 24-hour blood pressure measurements
Secondary outcomes
Self-reported health-related quality of life and functioning (SF-36)
The Short Form 36 Health Survey is a self-reported quality of life questionnaire consisting of eight scaled scores. Each scale is transformed directly into a 0-100 scale, where a lower score indicates greater difficulty.
Self-reported quality of life (WHOQoL-Bref)
The WHOQoL-Bref is a questionnaire where the participant's answers to 26 questions are used to create an overall quality of life profile. This profile includes scores for each dimension of the questionnaire: physical health, mental health, social relationships, and the participant's environment.
Subjective medication assesment
Subjective assesment of the medication after 6 months of use
Sponsors and contacts
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Aarhus University Hospital
Lead sponsor
University of Aarhus
Collaborator