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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorAarhus University Hospital

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 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 criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of TS regardless of karyotype

Age 18-50 years

Already receiving estrogen treatment

Disqualifiers

Active systemic chronic diseases

Known or suspected breast cancer

Known or suspected estradiol-dependent tumors (endometrial cancer or similar)

Untreated endometrial hyperplasia

Trial design

Design model

Crossover

Treatments tested in this trial

  • 17-beta estradiol

    Drug

    Treatment with orally administered estrogen for 14 days

  • 17-beta estradiol

    Drug

    Treatment with transdermally administered estrogen for 14 days

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Oral estrogen treatmentActive comparator 1 intervention
Group B: Transdermal estrogen treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Equipotency

Levels of luthenizing hormone and follicle stimulating hormone are measured at different doses

Time frame
After 14 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

University of Aarhus

Collaborator