RecruitingPhase 4NCT06570460

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

Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome - A Randomized Trial


Sponsor

Aarhus University Hospital

Enrollment

50 participants

Start Date

Nov 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 17-beta estradiol and a drug called 17-beta estradiol for people with estrogen deficiency, estrogen replacement therapy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG17-beta estradiol

Treatment with orally administered estrogen for 6 months

DRUG17-beta estradiol

Treatment with transdermally administered estrogen for 6 months


Locations(1)

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Aarhus, Aarhus N, Denmark

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NCT06570460


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