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ISRCTN
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ISRCTN08608368
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ClinicalTrials.gov identifier
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Public title
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Insulin sensitisation in post-menarcheal girls with a history of low birthweight and precocious pubarche: effects of the addition of antiandrogen treatment and of the androgen receptor length on body composition and endocrine-metabolic parameters
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The endocrine-metabolic effects of insulin sensitisation +/- antiandrogen therapy will be directly related to the length of CAG repeats of the androgen receptor gene.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Ovarian hyperandrogenism
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Participants - inclusion criteria
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1. Post-menarcheal state
2. A history of low birthweight and precocious pubarche
3. Subclinical ovarian hyperandrogenism
4. Hyperinsulinemia
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Participants - exclusion criteria
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1. Clinical signs of androgen excess
2. Family or personal history of diabetes mellitus
3. Late-onset congenital adrenal hyperplasia
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Anticipated start date
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20/10/2003
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Anticipated end date
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20/10/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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Insulin sensitisation +/- antiandrogen treatment
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Primary outcome measure(s)
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1. Development of clinical hyperandrogenism
2. Body composition
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Secondary outcome measure(s)
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1. Decrease of androgens
2. Improvement of insulin sensitivity
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Sources of funding
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Hospital Sant Joan de Deu (Spain)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17984247
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Contact name
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Prof
Lourdes
Ibañez
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Address
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Hospital Sant Joan de Deu
Passeig de Sant Joan de Deu 2
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City/town
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Esplugues, Barcelona
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Zip/Postcode
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08950
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Country
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Spain
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Sponsor
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Hospital Sant Joan de Deu (Spain)
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Address
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Passeig de Sant Joan de Deu, 2
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City/town
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Esplugues, Barcelona
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Zip/Postcode
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08950
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Country
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Spain
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Date applied
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07/09/2005
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Last edited
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11/09/2009
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Date ISRCTN assigned
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05/10/2005
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