Status:
RECRUITING
Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With 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 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 estab...
Detailed Description
OBJECTIVE 1\. To determine the equipotency of two different estradiol regimens (oral versus transdermal administration) using various estradiol-dependent surrogate markers. BACKGROUND Turner syndrom...
Eligibility Criteria
Inclusion
- Diagnosis of TS regardless of karyotype
- Age 18-50 years
- Already receiving estrogen treatment
Exclusion
- 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
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
NCT06544473
Start Date
November 29 2021
End Date
December 31 2026
Last Update
August 23 2024
Active Locations (1)
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1
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200