Effects of the addition of low-dose pioglitazone to combined flutamide-metformin treatment on endocrine-metabolic and body composition indices in young women with ovarian hyperandrogenism, hyperinsulinism and cardiovascular risk
| ISRCTN | ISRCTN12871246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12871246 |
| Protocol serial number | HSJD-LIT-05 |
| Sponsor | Hospital Sant Joan de Deu, University of Barcelona (Spain) |
| Funder | Hospital Sant Joan de Deu (Spain) |
- Submission date
- 17/11/2005
- Registration date
- 09/01/2006
- Last edited
- 08/04/2021
- 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 Ibanez
Scientific
Scientific
Hospital Sant Joan de Deu
University of Barcelona
Passeig de Sant Joan de Deu
2
Esplugues
08950
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, prospective, randomised, trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effects of the addition of low-dose pioglitazone to combined flutamide-metformin treatment on endocrine-metabolic and body composition indices in young women with ovarian hyperandrogenism, hyperinsulinism and cardiovascular risk |
| Study objectives | Hypothesis for the protocol extension added as of 05/07/2007: Therapy for three years with pioglitazone, metformin and flutamide will reverse the endocrine-metabolic and body composition abnormalities in young women with androgen excess. Previous hypothesis: The addition of low-dose pioglitazone to combined flutamide-metformin therapy will result in significant improvements in the endocrine-metabolic and body composition abnormalities associated with hyperandrogenic hyperinsulinism in young women with increased cardiovascular risk. |
| Ethics approval(s) | Ethics approval was received on the 5th November 2005; extensions approved on the 27th October 2006. |
| Health condition(s) or problem(s) studied | Ovarian hyperandrogenism with hyperinsulinism, dyslipemia and cardiovascular risk |
| Intervention | Please note that, as of 5 July 2007, the anticipated end date of this trial has been extended from 18 July 2006 to 31 December 2008. Interventions for the protocol extension added as of 05/07/2007: Over the last 18 months, patients will be randomised to receive for six months: 1. Pioglitazone, metformin and flutamide 2. Pioglitazone, metformin and placebo 3. Placebo, metformin and flutamide, or 4. Placebo, metformin and placebo The next six months, all patients will be treated with pioglitazone, metformin and flutamide (open phase), and over the last six months of the trial (double blinded, randomised), half of the patients will receive three placebos and the other half will remain on the same treatment. Previous interventions: One group will receive pioglitazone, flutamide and metformin; the other group will receive placebo, flutamide and metformin. Assessment of endocrine-metabolic variables, neutrophil count, C-Reactive Protein (CRP) levels, body composition, carotid intima media thickness at baseline, and at three and six months. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pioglitazone, flutamide, metformin |
| Primary outcome measure(s) |
1. C-reactive protein (CRP) levels |
| Key secondary outcome measure(s) |
1. Carotid intima-media thickness |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 40 |
| Total final enrolment | 38 |
| Key inclusion criteria | 1. Age 18 years or more 2. Menarche at least three years before inclusion 3. Clinical and/or biochemical signs of androgen excess 4. Hyperinsulinism 5. Dyslipidemia 6. Relative hyperneutrophilia, increased C-reactive protein (CRP) 7. Normal liver and kidney functions 8. Absence of non-classical adrenal hyperplasia due to 21-OH (21-hydroxylase) deficiency |
| Key exclusion criteria | 1. Age less than 18 years 2. Pregnancy 3. Hyperprolactinemia 4. Cushing's syndrome 5. Abnormal thyroid function 6. Liver or kidney dysfunction 7. Glucose intolerance 8. Type 1 or type 2 diabetes 9. Cutaneous allergy 10. Concomitant therapy with agents influencing lipid or carbohydrate metabolism. 11. Alcoholism 12. Bacterial infections |
| Date of first enrolment | 18/11/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Sant Joan de Deu
Esplugues
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 | 01/09/2009 | 08/04/2021 | Yes | No |
Editorial Notes
08/04/2021: Publication reference and total final enrolment added.
