Actively Recruiting
Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome
Led by Aarhus University Hospital · Updated on 2024-08-23
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 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.
CONDITIONS
Official Title
Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Turner syndrome regardless of karyotype
- Age 18-50 years
- Already receiving estrogen treatment
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 past liver disease with liver enzymes elevated by 3 times or more
- Known hypersensitivity to the study medications
- Pregnancy
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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
2
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