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Trial · Interventional

CompletedPhase 4Registry data

Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome

NCTNCT01518062 (opens ClinicalTrials.gov in a new tab)Other idGHTUR/BPD/5-13
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
65 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Netherlands

Start
Nov 1989
Primary completion
Sept 2003
Completion
Sept 2003
First posted
25 Jan 2012 (estimated)
Last update posted
18 Jan 2017 (estimated)
Conditions
Genetic Disorder · Turner Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
199019952000
  1. Ph 4

    Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome

    NCT01518062

    Nov 1989 to Sept 2003

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in Europe. The aim of this trial is to assess whether increasing doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and improve final height. This trial has two trial periods, a main period of 4 years and an extension period until final height is reached.

Interventions

  • somatropinDrug
  • somatropinDrug
  • somatropinDrug
  • oestrogenDrug

Arms3

  • Experimental

    Low dose

  • Experimental

    Medium dose

  • Experimental

    High dose

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Final height

Secondary outcomes(4)

  1. Height velocity (cm/year)

  2. Ratio between change in bone age and change in chronological age

  3. Age at onset of puberty

  4. Adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 1999

11 results

Normalization of height in girls with Turner syndrome after long-term growth hormone treatment: results of a randomized dose-response trial.

Sas et al. 1999The Journal of clinical endocrinology and metabolismcited by 95

PMID 10599727DOI 10.1210/jcem.84.12.6241PUB-10599727

Full text at the publisher11 results
Publisher pageSee results (11)

More studies

3 studies on this page

Indexing hint: Randomized controlled trial · 2005

Psychosocial functioning after discontinuation of long-term growth hormone treatment in girls with Turner syndrome.

van Pareren et al. 2005Hormone researchcited by 22

PMID 15900109DOI 10.1159/000085841PUB-15900109

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 1999

The effects of long-term growth hormone treatment on cardiac left ventricular dimensions and blood pressure in girls with Turner's syndrome. Dutch Working Group on Growth Hormone.

Sas et al. 1999The Journal of pediatricscited by 29

PMID 10518081DOI 10.1016/s0022-3476(99)70170-8PUB-10518081

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 1999

Body proportions during long-term growth hormone treatment in girls with Turner syndrome participating in a randomized dose-response trial.

Sas et al. 1999The Journal of clinical endocrinology and metabolismcited by 26

PMID 10599729DOI 10.1210/jcem.84.12.6225PUB-10599729

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • Resultvan Teunenbroek A, de Muinck Keizer-Schrama SM, Stijnen T, Jansen M, Otten BJ, Delemarre-van de Waal HA, Vulsma T, Wit JM, Rouwe CW, Reeser HM, Gosen JJ, Rongen-Westerlaken C, Drop SL. Yearly stepwise increments of the growth hormone dose results in a better growth response after four years in girls with Turner syndrome. Dutch Working Group on Growth Hormone. J Clin Endocrinol Metab. 1996 Nov;81(11):4013-21. doi: 10.1210/jcem.81.11.8923853. PMID 8923853
  • ResultVan Pareren YK, De Muinck Keizer-Schrama SM, Stijnen T, Sas TC, Drop SL. Effect of discontinuation of long-term growth hormone treatment on carbohydrate metabolism and risk factors for cardiovascular disease in girls with Turner syndrome. J Clin Endocrinol Metab. 2002 Dec;87(12):5442-8. doi: 10.1210/jc.2002-020789. PMID 12466334
  • Resultvan Pareren YK, de Muinck Keizer-Schrama SM, Stijnen T, Sas TC, Jansen M, Otten BJ, Hoorweg-Nijman JJ, Vulsma T, Stokvis-Brantsma WH, Rouwe CW, Reeser HM, Gerver WJ, Gosen JJ, Rongen-Westerlaken C, Drop SL. Final height in girls with turner syndrome after long-term growth hormone treatment in three dosages and low dose estrogens. J Clin Endocrinol Metab. 2003 Mar;88(3):1119-25. doi: 10.1210/jc.2002-021171. PMID 12629094

Eligibility

Who could join, as posted.

Sex
Female
Age
from 2 Years up to 11 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Turner Syndrome * Well documented growth rate during the previous year * Height below the 50th percentile for the age in Dutch children * Normal thyroid function Exclusion Criteria: * Any endocrine or metabolic disorder * Growth failure due to disorders of genitourinary, cardio-pulmonary, gastro-intestinal and nervous systems, nutritional/vitamins deficiencies and chondrodysplasias * Patients with hydrocephalus

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