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
| ISRCTN | ISRCTN08608368 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08608368 |
| Protocol serial number | N/A |
| Sponsor | Hospital Sant Joan de Deu (Spain) |
| Funder | Hospital Sant Joan de Deu (Spain) |
- Submission date
- 07/09/2005
- Registration date
- 05/10/2005
- Last edited
- 11/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Lourdes Ibañez
Scientific
Scientific
Hospital Sant Joan de Deu
Passeig de Sant Joan de Deu 2
Esplugues, Barcelona
08950
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ovarian hyperandrogenism |
| Intervention | Insulin sensitisation +/- antiandrogen treatment |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Insulin, antiandrogen |
| Primary outcome measure(s) |
1. Development of clinical hyperandrogenism |
| Key secondary outcome measure(s) |
1. Decrease of androgens |
| Completion date | 20/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Female |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Post-menarcheal state 2. A history of low birthweight and precocious pubarche 3. Subclinical ovarian hyperandrogenism 4. Hyperinsulinemia |
| Key exclusion criteria | 1. Clinical signs of androgen excess 2. Family or personal history of diabetes mellitus 3. Late-onset congenital adrenal hyperplasia |
| Date of first enrolment | 20/10/2003 |
| Date of final enrolment | 20/10/2006 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Sant Joan de Deu
Esplugues, Barcelona
08950
Spain
08950
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2007 | Yes | No |
