Clinical Trials Logo
  1. Home
  2. Turner Syndrome
  3. NCT01518036
  4. Details
NCT01518036 Clinical Trial

Use of Somatropin in Turner Syndrome

Turner Syndrome Clinical Trial

Official title:
The Use of Norditropin® in Turner's Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01518036
Other study ID # GHTUR/BPD/1
Secondary ID
Status Completed
Phase Phase 3
First received January 20, 2012
Last updated February 27, 2017
Start date September 14, 1987
Est. completion date April 11, 2004

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date April 11, 2004
Est. primary completion date April 11, 2004
Accepts healthy volunteers No
Gender Female
Age group 2 Years to 11 Years
Eligibility Inclusion Criteria:

- Turner Syndrome

- Not previously treated with growth hormone or androgen

- Well-documented height over the previous 12 months

- Informed consent of parents (and child if appropriate)

Exclusion Criteria:

- Growth hormone (GH) deficiency based on a GH stimulation test

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
• somatropin
4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached

Locations
Country Name City State
United Kingdom Novo Nordisk Investigational Site Crawley

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Final height in cm
Secondary Ratio between change in bone age and change in chronological age
Secondary Age at onset of puberty
Secondary Adverse events
See also
  Status Clinical Trial Phase
Completed NCT01734486 - Growth Response in Girls With Turner Syndrome Phase 4
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Completed NCT01419249 - First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study Phase 4
Recruiting NCT04948658 - Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT02787486 - Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Completed NCT00877942 - Sex Differences in Early Brain Development; Brain Development in Turner Syndrome N/A
Completed NCT00825617 - Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy N/A
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Enrolling by invitation NCT03836300 - Parent and Infant Inter(X)Action Intervention (PIXI) N/A
Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
Completed NCT01322165 - National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions N/A
Terminated NCT00419107 - Beta Cell Function in Women With Turner Syndrome N/A
Active, not recruiting NCT00625001 - Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome N/A
Completed NCT00029159 - The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome Phase 3
Completed NCT01518062 - Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome Phase 4
Completed NCT00471731 - Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure N/A
Completed NCT00256126 - Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® Phase 4
Completed NCT03181230 - Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
Completed NCT02160717 - Risk of Diabetes in Young Turner Syndrome Patients N/A

External Links