Comparing oral and transdermal estrogen treatment in women with Turner syndrome
Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome - A Randomized Study
This study is testing whether taking estrogen by mouth or through the skin works better for women with Turner syndrome.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus, Aarhus N) |
| Trial ID | NCT06544473 on ClinicalTrials.gov |
What this trial studies
This phase IV randomized crossover trial evaluates the effects of oral versus transdermal estrogen replacement therapy in women with Turner syndrome. Over a 5-week period, 50 participants aged 18-50 will receive each treatment for 14 days, separated by a one-week washout. The study aims to determine the dose equivalence of the two estradiol regimens by measuring various estradiol-dependent markers. Blood tests will be conducted at multiple points to assess the impact of each treatment method.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-50 with a diagnosis of Turner syndrome who are already receiving estrogen treatment.
Not a fit: Patients with active systemic chronic diseases, known or suspected breast cancer, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for estrogen replacement therapy in women with Turner syndrome, potentially improving their health outcomes.
How similar studies have performed: While there is ongoing debate regarding the advantages of oral versus transdermal estrogen, this specific comparison in Turner syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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) * 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
Where this trial is running
Aarhus, Aarhus N
- Department of Endocrinology and Internal Medicine, Aarhus University Hospital — Aarhus, Aarhus N, Denmark (Recruiting)
Study contacts
- Principal investigator: Claus H Gravholt, Professor — Aarhus University Hospital
- Study coordinator: Camilla M Balle, Ph.d.-student
- Email: camibl@clin.au.dk
- Phone: 40769623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.