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

RecruitingPhase 4Ages 18 Years - 50 YearsFemaleAarhus University Hospital
NCT06570460 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 treatmen

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📋 Eligibility rules (as published)
Inclusion criteria: For participants with TS: * Diagnosis of TS regardless of karyotype * Age 18-50 years * Already receiving estrogen treatment For healthy controls: * Female * Age 18-50 years * Previously healthy * Not receiving any medication * Not using any form of contraceptive pills * No mental or psychiatric disorders Exclusion criteria: * Active systemic chronic diseases * Known or suspected breast cancer * Known or suspected estradiol-dependent tumors (endometrial cancer or similar) * Untreated endometrial hyperplasia * Current or previous venous thromboembolism * Acute or previous liver disease where liver enzymes are still elevated by a factor 3 or more * Known hypersensitivity to the medications used * Pregnancy * Menopause (for the control group only)
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What it tests

  • 17-beta estradiol
  • 17-beta estradiol
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Where

1 site
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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