Comparing oral and transdermal estrogen therapy in women with Turner syndrome
Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome - A Randomized Trial
This study is testing whether taking estrogen as a pill or through the skin is better for women with Turner syndrome in terms of their overall health and well-being.
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 | NCT06570460 on ClinicalTrials.gov |
What this trial studies
This phase IV, randomized controlled crossover trial investigates the long-term effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome. The study involves 50 participants with Turner syndrome aged 18-50, who will undergo a wash-out period before being randomized to receive either oral or transdermal ERT for six months, followed by a crossover to the alternate treatment for another six months. The trial aims to clarify various health risks associated with Turner syndrome and evaluate the efficacy of both ERT routes on endocrine, metabolic, cardiovascular, and thromboembolic factors.
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 postmenopausal will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective form of estrogen therapy for women with Turner syndrome, potentially improving their long-term health outcomes.
How similar studies have performed: While there is ongoing debate regarding the best method of estrogen administration in Turner syndrome, this specific comparative approach has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: For participants with TS: * Diagnosis of TS regardless of karyotype * Age 18-50 years * Already receiving estrogen treatment For healthy controls: * Female * Age 18-50 years * Previously healthy * Not receiving any medication * Not using any form of contraceptive pills * No mental or psychiatric disorders 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 * Menopause (for the control group only)
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.