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
Healthy Volunteers
ID06570460
Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome A Randomized Trial
Led by Aarhus University Hospital · Updated on 2024-08-26
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 comparing the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome (TS), a genetic condition causing ovarian failure and estrogen deficiency. This 14-month, phase IV randomized controlled crossover trial aims to better understand endocrine, metabolic, cardiovascular, and thromboembolic risks after a washout period without estrogen treatment. The study involves 50 women with TS aged 18-50 years and 50 healthy controls to clarify long-term effects of ERT through different administration routes. Participants with TS will stop any current estrogen treatment for one month before randomization, then receive either oral or transdermal estrogen therapy for six months, followed by a one-month washout and crossover to the other treatment for another six months. The control group of healthy women will not receive treatment but will undergo assessments for comparison. Treatments studied include oral estradiol (Estrofem®) and transdermal estradiol (Divigel®). During the study, participants will undergo blood and urine tests, 24-hour blood pressure monitoring, DEXA scans, muscle strength and function tests, MRI muscle imaging, and quality of life questionnaires. Assessments occur at baseline, after the washout period, and after each six-month treatment phase. The main outcomes measured include blood values, cardiovascular status, muscle quality, and oxygen uptake. Safety and quality of life will also be monitored. The study aims to improve hormone replacement recommendations for TS patients.
CONDITIONS
Brief Title
Long Term Effects of Oral Versus Transdermal Estrogen Replacement Therapy in Turner Syndrome
Who Can Participate
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Diagnosis of Turner syndrome regardless of karyotype
- Age between 18 and 50 years
- Already receiving estrogen treatment
- Female
- Previously healthy (for control group)
- Not receiving any medication (for control group)
- Not using any form of contraceptive pills (for control group)
- No mental or psychiatric disorders (for control group)
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 elevated liver enzymes by a factor of 3 or more
- Known hypersensitivity to study medications
- Pregnancy
- Menopause (for the control group only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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)
Washout Period
Duration - 1 month
Participants with Turner syndrome discontinue existing estrogen treatment for 1 month before starting study treatments.
1 visit (in-person) before and 1 visit after washout
Treatment
Duration - 6 months per treatment phase, totaling 12 months
Participants with Turner syndrome receive either oral or transdermal estrogen replacement therapy for 6 months, then switch to the alternate treatment for another 6 months.
Visits occur at the start and end of each 6-month treatment phase
Washout Period
Duration - 1 month
A second 1-month washout period occurs between the two treatment phases with no estrogen treatment.
1 visit (in-person) before starting the second treatment phase
Follow-up Assessments
Duration - Throughout the 14-month study period
Participants undergo clinical and laboratory assessments after each treatment phase to evaluate the effects of estrogen therapy.
Multiple assessment visits including blood tests, imaging, and functional tests
Control Group Assessments
Duration - Single time point
Healthy age-matched control participants undergo a single set of baseline assessments for comparison.
1 visit (in-person)
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
3
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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