Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome - A Randomized Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Diagnosis of TS regardless of karyotype

• Age 18-50 years

• Already receiving estrogen treatment

Locations
Other Locations
Denmark
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Camilla M Balle, Ph.d.-student
camibl@clin.au.dk
40769623
Backup
Claus H Gravholt, Professor
claus.gravholt@clin.au.dk
78455470
Time Frame
Start Date: 2021-11-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Active_comparator: Oral estrogen treatment
Turner syndrome patients receiving oral estrogen treatment (Estrofem®)
Active_comparator: Transdermal estrogen treatment
Turner syndrome patients receiving transdermal estrogen treatment (Divigel)
Sponsors
Collaborators: University of Aarhus
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov