Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With 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, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- 17-beta estradiol
- Record updated
- 23 August 2024
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Diagnosis of TS regardless of karyotype
- Age 18-50 years
- Already receiving estrogen treatment
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
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 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.
The 2 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
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
- Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome - A Randomized Study
- Fit questions
- Built from NCT06544473, who can take part
- Record updated
- 23 August 2024