Prevalence, incidence, diagnostic delay, and mortality in Turner syndrome.
Kirstine Stochholm, Svend Juul, Knud Juel...
https://pubmed.ncbi.nlm.nih.gov/16849410Actively Recruiting
Phase 4
Age: 18Years - 50Years
FEMALE
ID06544473
Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome - A Randomized Study
Led by Aarhus University Hospital · Updated on 2024-08-23
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
U
University of Aarhus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two forms of estrogen replacement therapy (ERT) in women with Turner syndrome (TS), a genetic condition causing ovarian failure and hormone deficiencies. This phase IV randomized crossover trial aims to compare oral and transdermal estradiol treatments to determine if the two methods are equally effective by examining various markers influenced by estradiol. The study involves 50 women aged 18 to 50 years who are already receiving estrogen therapy. Participants are randomly assigned to receive either oral or transdermal 17-beta estradiol for 14 days, then switch to the other treatment after a one-week washout period, completing another 14 days of the alternate therapy. Blood samples are collected at four key points: before treatment, after the first 14 days, after the washout, and after the final 14 days. This design helps assess how the body responds to each treatment method over time. Throughout the 5-week study, participants undergo blood tests to monitor estradiol-dependent markers and the body's response to each treatment. Researchers will analyze changes in these markers to determine dose equivalence between oral and transdermal estrogen. The study also monitors safety and treatment effects, aiming to provide better guidance for hormone therapy in women with TS and contribute knowledge applicable to hormone replacement in the general population.
CONDITIONS
Brief Title
Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Diagnosis of Turner syndrome regardless of karyotype
- Age between 18 and 50 years
- Currently receiving estrogen treatment
You will not qualify if you...
- Active systemic chronic diseases
- Known or suspected breast cancer
- Known or suspected estradiol-dependent tumors such as endometrial cancer
- Untreated endometrial hyperplasia
- Current or previous venous thromboembolism
- Acute or previous liver disease with liver enzymes elevated by a factor of 3 or more
- Known hypersensitivity to the medications used
- Pregnancy
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 weeks
Participants receive estrogen treatment in a randomized crossover design, with 14 days of oral estrogen followed by a one-week washout and then 14 days of transdermal estrogen, or vice versa.
4 visits (in-person): baseline, after first 14 days treatment, after washout, after final 14 days treatment
Trial Site Locations
Total: 1 location
1
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
Actively Recruiting
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Research Team
C
Camilla M Balle, Ph.d.-student
C
Claus H Gravholt, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Clinical practice guidelines for the care of girls and women with Turner syndrome: proceedings from the 2016 Cincinnati International Turner Syndrome Meeting.
Claus H Gravholt, Niels H Andersen, Gerard S Conway...
https://pubmed.ncbi.nlm.nih.gov/28705803Turner syndrome and clinical treatment.
Britta E Hjerrild, Kristian Havmand Mortensen, Claus H Gravholt
https://pubmed.ncbi.nlm.nih.gov/18400842Clinical and epidemiological description of aortic dissection in Turner's syndrome.
Claus Højbjerg Gravholt, Kerstin Landin-Wilhelmsen, Kirstine Stochholm...
https://pubmed.ncbi.nlm.nih.gov/16984695Carotid intima-media thickness is increased in Turner syndrome: multifactorial pathogenesis depending on age, blood pressure, cholesterol and oestrogen treatment.
Kristian H Mortensen, Niels H Andersen, Britta E Hjerrild...
https://pubmed.ncbi.nlm.nih.gov/22233516Executive Functions in Children and Adolescents with Turner Syndrome: A Systematic Review and Meta-Analysis.
Claire Mauger, Céline Lancelot, Arnaud Roy...
https://pubmed.ncbi.nlm.nih.gov/29704077Female hormones: do they influence muscle and tendon protein metabolism?
Mette Hansen
https://pubmed.ncbi.nlm.nih.gov/28847313Hormone therapy and skeletal muscle strength: a meta-analysis.
Sarah M Greising, Kristen A Baltgalvis, Dawn A Lowe...
https://pubmed.ncbi.nlm.nih.gov/19561145Hormone replacement therapy and risk of venous thromboembolism in postmenopausal women: systematic review and meta-analysis.
Marianne Canonico, Geneviève Plu-Bureau, Gordon D O Lowe...
https://pubmed.ncbi.nlm.nih.gov/18495631Transdermal and oral hormone replacement therapy and the risk of stroke: a nested case-control study.
Christel Renoux, Sophie Dell'aniello, Edeltraut Garbe...
https://pubmed.ncbi.nlm.nih.gov/20525678