NCT06570460 Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome
| NCT ID | NCT06570460 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Aarhus University Hospital |
| Condition | Turner Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-11-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2021-11-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This 14-month, phase IV, randomized controlled crossover trial aims to compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS). The study's objectives are to clarify endocrine, metabolic, cardiovascular, and thromboembolic risk factors in TS after a wash-out period without estrogen (E2) treatment; compare the effects of oral versus transdermal (TD) ERT regimens; and examine the long-term effects of E2 administration via these two routes. The study involves 50 TS women aged 18-50 years and 50 control participants. TS participants are randomized to receive either oral or TD ERT for six months, followed by crossover to the alternate treatment for another six months. Prior to randomization, any existing ERT will be discontinued for a 1-month washout period. A second 1-month washout period will occur between the two 6-month treatment phases. Laboratory analyses and clinical investigations are performed after the first wash-out period, after the first six months of treatment, and after the last six months of treatment. We anticipate that this study may provide a basis for new and improved recommendations for sex hormone replacement therapy in TS.
Eligibility 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)
Contact & Investigator
Claus H Gravholt, Professor
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06570460 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Turner Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06570460 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06570460 currently recruiting?
Yes, NCT06570460 is actively recruiting participants. Contact the research team at camibl@clin.au.dk for enrollment information.
Where is the NCT06570460 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06570460 clinical trial?
NCT06570460 is sponsored by Aarhus University Hospital. The principal investigator is Claus H Gravholt, Professor at Aarhus University Hospital. The trial plans to enroll 50 participants.