Condition category
Urological and Genital Diseases
Date applied
11/08/2005
Date assigned
05/10/2005
Last edited
11/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lourdes Ibanez

ORCID ID

Contact details

Hospital Sant Joan de Deu
University of Barcelona
Esplugues
Barcelona
08950
Spain

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 measures

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

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

http://www.hsjd.org

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/15356029

Publication citations

  1. 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.

Additional files

Editorial Notes