Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome
Key facts
- Who runs it
- Aarhus University Hospital
- Where
- Denmark1 site in 1 countryChoose a country to see its sites
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 50 people, planned
- Started
- 29 Nov 2021
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- 17-beta estradiol
- Record updated
- 26 August 2024
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Current or previous venous thromboembolism
- Acute or previous liver disease where liver enzymes are still elevated by a factor 3 or more
- Active systemic chronic diseases
- Known or suspected breast cancer
- Known or suspected estradiol-dependent tumors (endometrial cancer or similar)
- Known hypersensitivity to the medications used
- Untreated endometrial hyperplasia
- Pregnancy
- Menopause (for the control group only)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Oral estrogen treatmentExisting treatment, for comparison
Turner syndrome patients receiving oral estrogen treatment (Estrofem®)
Treatment: 17-beta estradiol
- Transdermal estrogen treatmentExisting treatment, for comparison
Turner syndrome patients receiving transdermal estrogen treatment (Divigel)
Treatment: 17-beta estradiol
- ControlsNo study treatment, for comparison
Healthy age-matched controls receiving no treatment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome - A Randomized Trial
- Fit questions
- Built from NCT06570460, who can take part
- Record updated
- 26 August 2024