Status:
RECRUITING
Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome
Lead Sponsor:
Aarhus University Hospital
Collaborating Sponsors:
University of Aarhus
Conditions:
Turner Syndrome
Hypogonadism; Ovarian
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief 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...
Detailed Description
OBJECTIVES 1. Clarify endocrine, metabolic, cardiovascular and thromboembolic risk factors in Turner syndrome (TS) after a wash out period 2. Compare the effects of oral versus transdermal (TD) estro...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06570460
Start Date
November 29 2021
End Date
December 31 2026
Last Update
August 26 2024
Active Locations (1)
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1
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200