Condition category
Urological and Genital Diseases
Date applied
24/08/2005
Date assigned
05/10/2005
Last edited
11/09/2009
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 Ibañez

ORCID ID

Contact details

Hospital Sant Joan de Déu
University of Barcelona
Esplugues
08950
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Metformin-Puberty

Study hypothesis

Modulation of insulin-signalling contributes to variation in the tempo of pubertal progression in girls.

Ethics approval

Not provided at time of registration

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

Advanced and progressive puberty in low-birthweight girls, resulting in final height below target

Intervention

Insulin sensitisation: metformin 850 mg/day versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Metformin

Primary outcome measures

1. Menarche
2. Final height

Secondary outcome measures

1. Fasting insulin
2. IGF-I

Overall trial start date

20/10/2002

Overall trial end date

25/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Birthweight for gestational age below -1.5 standard deviation (SD)
2. Onset of breast development (Tanner stage 2, B2) between age 8-9 years and <12 months before study start
3. Height SD score (SDS) at enrollment at least 1 SD above mid-parental height
4. Height velocity >6 cm/year
5. Progressive puberty, as assessed by pelvic ultrasonography and by gonadotropin and steroid responses to gonadotropin releasing hormone (GnRH) agonist stimulation

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

22

Participant exclusion criteria

A family or personal history of diabetes mellitus; a history of precocious pubarche; evidence for thyroid dysfunction, Cushing syndrome, hyperprolactinemia or glucose intolerance; medication known to affect gonadal function or carbohydrate metabolism.

Recruitment start date

20/10/2002

Recruitment end date

25/06/2006

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Sant Joan de Déu
Esplugues
08950
Spain

Sponsor information

Organisation

Hospital Sant Joan de Deu (Spain)

Sponsor details

University of Barcelona
Passeig de Sant Joan de Déu
2
Esplugues
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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16492692
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17608755

Publication citations

  1. Results

    Ibáñez L, Valls C, Ong K, Dunger DB, de Zegher F, Metformin therapy during puberty delays menarche, prolongs pubertal growth, and augments adult height: a randomized study in low-birth-weight girls with early-normal onset of puberty., J. Clin. Endocrinol. Metab., 2006, 91, 6, 2068-2073, doi: 10.1210/jc.2005-2329.

  2. Results

    Ong K, de Zegher F, Valls C, Dunger DB, Ibáñez L, Persisting benefits 12-18 months after discontinuation of pubertal metformin therapy in low birthweight girls., Clin. Endocrinol. (Oxf), 2007, 67, 3, 468-471, doi: 10.1111/j.1365-2265.2007.02952.x.

Additional files

Editorial Notes