Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome
Recruiting
Phase 4
Interventional Study
Turner Syndrome
Hypogonadism; Ovarian
Hormone Replacement Therapy
Estrogen Replacement Therapy
Estrogen Deficiency
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 50
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Aarhus University Hospital · Other
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About This Trial
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 receiv…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of TS regardless of karyotype
* Age 18-50 years
* Already receiving estrogen treatment
Exclusion Criteria:
* Active systemic chronic diseases
* Known or suspected breast cancer
* Known or suspected estradiol-dependent tumors (endometrial cancer or similar)
* Untrea…
Contacts