Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome
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Purpose
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 |
|---|---|---|
|
Turner Syndrome |
Drug: estradiol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- The size of the uterus evaluated by magnetic resonance (MR)-scan [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Bones evaluated by dual-energy X-ray absorptiometry (DEXA)-scan [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- The diameter of the aortic root evaluated by MR-scan [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Development of biochemical markers [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Body composition evaluated by DEXA-scan [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Emotional wellbeing and self-esteem evaluated by questionnaires [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- The size of the uterus evaluated by ultrasound [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 43 |
| Study Start Date: | June 2005 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 4 mg estradiol |
Drug: estradiol
tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years
|
| Placebo Comparator: 2 mg estradiol |
Drug: estradiol
tablets, 2 mg day 1 through day 22 of the menstrual cycle for 5 years
|
Detailed Description:
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 to 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.
Eligibility| Ages Eligible for Study: | 10 Years to 25 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Verified Turner syndrome
- Ages 10-25 years
Exclusion Criteria:
- Contraindications to the MR-scan
- Contraindications to the trial medication
- Severe or chronic sickness with impact on the parameters of the study or incompatibility with the trial medication
- Intake of medications with interactions with trial medication
Contacts and Locations| Denmark | |
| Pediatric Unit, Hillerod Hospital | |
| Hillerod, Frederiksborg County, Denmark, 4300 | |
| Principal Investigator: | Line Cleemann, Doctor | Pediatric Unit, Hillerod Hospital |
More Information
No publications provided
| Responsible Party: | Line Cleemann, Doctor, PhD, Hillerod Hospital, Denmark |
| ClinicalTrials.gov Identifier: | NCT00134745 History of Changes |
| Other Study ID Numbers: | 120895 |
| Study First Received: | August 24, 2005 |
| Last Updated: | June 13, 2013 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by Hillerod Hospital, Denmark:
|
Turner Syndrome Hormonal replacement therapy Bone mineralization Uterine size aortic root dilatation |
Additional relevant MeSH terms:
|
Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Sex Chromosome Disorders Chromosome Disorders Genetic Diseases, Inborn Gonadal Disorders |
Endocrine System Diseases Ovarian Diseases Adnexal Diseases Genital Diseases, Female Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents |
ClinicalTrials.gov processed this record on June 17, 2013