Condition category
Urological and Genital Diseases
Date applied
07/09/2005
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 Deu
Passeig de Sant Joan de Deu 2
Esplugues
Barcelona
08950
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The endocrine-metabolic effects of insulin sensitisation +/- antiandrogen therapy will be directly related to the length of CAG repeats of the androgen receptor gene.

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

Ovarian hyperandrogenism

Intervention

Insulin sensitisation +/- antiandrogen treatment

Intervention type

Drug

Phase

Not Specified

Drug names

Insulin, antiandrogen

Primary outcome measures

1. Development of clinical hyperandrogenism
2. Body composition

Secondary outcome measures

1. Decrease of androgens
2. Improvement of insulin sensitivity

Overall trial start date

20/10/2003

Overall trial end date

20/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Post-menarcheal state
2. A history of low birthweight and precocious pubarche
3. Subclinical ovarian hyperandrogenism
4. Hyperinsulinemia

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

20

Participant exclusion criteria

1. Clinical signs of androgen excess
2. Family or personal history of diabetes mellitus
3. Late-onset congenital adrenal hyperplasia

Recruitment start date

20/10/2003

Recruitment end date

20/10/2006

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

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 Deu (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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17984247

Publication citations

  1. Results

    Ong KK, de Zegher F, López-Bermejo A, Dunger DB, Ibáñez L, Flutamide metformin for post-menarcheal girls with preclinical ovarian androgen excess: evidence for differential response by androgen receptor genotype., Eur. J. Endocrinol., 2007, 157, 5, 661-668, doi: 10.1530/EJE-07-0261.

Additional files

Editorial Notes