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Sponsors and Collaborators: |
Hillerod Hospital, Denmark Novo Nordisk The County of Frederiksborg The foundation of Kaptajnløjtnant Harald Jensen and Wife The foundation of Queen Louise childrens hospital The foundation of Mrs. Olga Bryde The foundation of Mr. Ivan Nielsen |
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Information provided by: | Hillerod Hospital, Denmark |
ClinicalTrials.gov Identifier: | NCT00134745 |
The purpose of this study is to examine whether a larger dosage of estrogen than the one used today will secure the development of a normal sized uterus and increase the strength of the bones in girls and young women with Turner syndrome.
The purpose is also to evaluate whether aortic dilatation is present in this group of patients, and if the estrogen dosage will influence the emotional well-being and self-esteem of the patients.
Condition | Intervention | Phase |
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Turner Syndrome |
Drug: estradiol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacodynamics Study |
Official Title: | The Growth of Genitalia Interna and the Bone Mineralization Under Hormonal Replacement Therapy and the Presence of Aortic Root Dilatation in Girls With Turner Syndrome |
Estimated Enrollment: | 60 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Turner syndrome is a common chromosomal disorder with only one X-chromosome or partial deletions in one X-chromosome in all or some of the cell-lines in the body. Appr. 18 girls/year are being born with the syndrome in Denmark. The syndrome is mostly known for reduced final height and the lack of pubertal development with infertility, but it is also known for diseases influencing other parts of the body like the heart with the risk of development of aortic dilatation and subsequently dissection with the risk of rupture, profuse bleeding and sudden death. Reduced bone strength and increased risk of bone fracture are also features of the syndrome. Treatment with growth hormone and female sex-hormones are well-established treatments.
Girls and young women with Turner syndrome ages 10 til 21 years will participate. The girls ages 15 to 21 years will randomly and double blindly receive treatment with either 2 mg or 4 mg estrogen for 5 years. Yearly examinations with blood tests, physical examinations, questionnaires, ultrasound and MR-scan of the internal female genitalia, DEXA-scan of the bones and MR-scan of the heart will be performed.
Ages Eligible for Study: | 10 Years to 25 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Line Cleemann, Doctor | +45 48294356 | licle@noh.regionh.dk |
Contact: Kirsten Holm, Doctor, Ph.D. | +45 48294829 | kihol@noh.regionh.dk |
Denmark, Frederiksborg County | |
Pediatric Unit, Hillerod Hospital | Recruiting |
Hillerod, Frederiksborg County, Denmark, 4300 | |
Contact: Line Cleemann, Doctor +45 48294356 licle@noh.regionh.dk | |
Contact: Kirsten Holm, Doctor, Ph.D. +45 49294829 kihol@noh.regionh.dk |
Principal Investigator: | Line Cleemann, Doctor | Pediatric Unit, Hillerod Hospital |
Responsible Party: | Hillerod Hospital ( Dr. Line Cleemann ) |
Study ID Numbers: | 120895 |
Study First Received: | August 24, 2005 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00134745 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Turner Syndrome Hormonal replacement therapy Bone mineralization Uterine size aortic root dilatation |
Chromosomal abnormalities Genital dwarfism Dilatation, Pathologic Gonadal Disorders Estradiol valerate Chromosome Disorders Endocrine System Diseases Estradiol 17 beta-cypionate Sex Differentiation Disorders Estradiol Monosomy X |
Turner Syndrome Gonadal dysgenesis Urogenital Abnormalities Genetic Diseases, Inborn Estradiol 3-benzoate Turner syndrome Ovarian dwarfism Endocrinopathy Polyestradiol phosphate Congenital Abnormalities Gonadal Dysgenesis |
Pathologic Processes Disease Syndrome Sex Chromosome Disorders |