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

Not Applicable

Completed

• Conditions: Ovarian hyperandrogenism with hyperinsulinism, dyslipemia and cardiovascular risk; Urological and Genital Diseases; Ovarian hyperandrogenism

• Registration Number: ISRCTN12871246
• Lead Sponsor: Hospital Sant Joan de Deu, University of Barcelona (Spain)

Brief Summary

2009 results in https://pubmed.ncbi.nlm.nih.gov/19018783/ (added 08/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-09
• Study Completion: 2008-12-31
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 38

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified