Actively Recruiting
Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome
Led by Aarhus University Hospital · Updated on 2024-08-26
50
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
U
University of Aarhus
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Turner syndrome regardless of karyotype
- Age between 18 and 50 years
- Currently receiving estrogen treatment (for Turner syndrome participants)
- Female sex (for healthy controls)
- Previously healthy (for healthy controls)
- Not taking any medication (for healthy controls)
- Not using any form of contraceptive pills (for healthy controls)
- No mental or psychiatric disorders (for healthy controls)
You will not qualify if you...
- Active systemic chronic diseases
- Known or suspected breast cancer
- Known or suspected estradiol-dependent tumors such as endometrial cancer
- Untreated endometrial hyperplasia
- Current or previous venous thromboembolism
- Acute or previous liver disease with elevated liver enzymes (3 times above normal)
- Known hypersensitivity to study medications
- Pregnancy
- Menopause (for healthy control group only)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
C
Camilla M Balle, Ph.d.-student
CONTACT
C
Claus H Gravholt, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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