Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome

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 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.

Eligibility

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)
* 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

Conditions6

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