Ovarian hyperandrogenism with hyperinsulinism, dyslipemia and cardiovascular risk Urological and Genital Diseases Ovarian hyperandrogenism
Conditions
Interventions
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
the other group will receive placebo, flutamide and metformin.
Assessment of endocrine-metabolic variables, neutrophil count, C-Reactive Protein (CRP) levels, body composition, caroti
Sponsors
Hospital Sant Joan de Deu, University of Barcelona (Spain)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. C-reactive protein (CRP) levels 2. Neutrophil count 3. Serum androgens 4. Fasting insulin 5. Lipid profile | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Carotid intima-media thickness 2. Body composition (visceral fat) 3. High molecular weight adiponectin (added as of 05/07/2007 as part of the extension) | — |
Countries
Spain
Outcome results
None listed