Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
P&M
Study hypothesis
Insulin sensitisation delays pubertal onset in low birthweight girls with precocious pubarche.
Please note that as of 11/07/2008, this trial has been updated. All updates can be found in the relevant field under the update date.
Ethics approval
Added 11/07/2008:
Ethics approval received from the Comité de Recerca, Hospital Sant Joan de Déu, University of Barcelona (Spain) on the 11th April 2001. The original protocol was also approved by the Agencia Española del Medicamento (ref: 01-0056, code HSJD-LIT-01). An amendment was presented in January 2008; the absence of reply from the administration implies approval.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Precocious pubarche
Intervention
Randomised subgroups:
1. Metformin 425 mg/day
2. Untreated
Added as of 11/07/2008:
Cross-over of therapy from year 6 of follow-up. All patients have been off therapy from year 5 (July 2007) to year 6.
Intervention type
Drug
Phase
Not Specified
Drug names
Metformin
Primary outcome measure
Onset of puberty, measured at baseline and every 6 months (timepoints added 11/07/2008)
Secondary outcome measures
1. Menarche, measured baseline and every 6 months. All untreated girls are already menarcheal, 14 of 19 treated girls are mernarcheal.
2. Final height, measured end of the 6th year
Timepoints added 11/07/2008
Overall trial start date
10/10/2002
Overall trial end date
10/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Girls with a combined history of low birthweight (less than 1.5 standard deviation score [SDS]) and precocious pubarche (appearance of pubic hair before age 8)
Participant type
Patient
Age group
Child
Gender
Female
Target number of participants
38
Participant exclusion criteria
1. Congenital adrenal hyperplasia
2. Diabetes mellitus
3. Thyroid dysfunction
Recruitment start date
10/10/2002
Recruitment end date
10/10/2007
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Sant Joan de Deu
Esplugues, Barcelona
08950
Spain
Sponsor information
Organisation
Hospital Sant Joan de Deu (Spain)
Sponsor details
University of Barcelona
Passeig de Sant Joan de Deu
2
Esplugues
Barcelona
08950
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital Sant Joan de Déu (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/15356029
Publication citations
-
Results
Ibáñez L, Valls C, Marcos MV, Ong K, Dunger DB, De Zegher F, Insulin sensitization for girls with precocious pubarche and with risk for polycystic ovary syndrome: effects of prepubertal initiation and postpubertal discontinuation of metformin treatment., J. Clin. Endocrinol. Metab., 2004, 89, 9, 4331-4337, doi: 10.1210/jc.2004-0463.