BridgeMD
Compares treatment options for Turner Syndrome
Official title Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome
ClinicalTrials.gov ID: NCT06570460
What this study is testing
What is 17-beta estradiol?
17-beta estradiol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for turner syndrome.
Also referred to as Estrofem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- For participants with TS:
- Diagnosis of TS regardless of karyotype
- Age 18-50 years
- Already receiving estrogen treatment For healthy controls:
- Female
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Aarhus N, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Aarhus N, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.