Effects on Endocrine-Metabolic Parameters and Body Composition of the Addition of Low-Dose Pioglitazone to Flutamide-Metformin Therapy in Young Women with Hyperinsulinemic Ovarian Hyperandrogenism and Cardiovascular Risk - Pioglitazone in PCOS

• Conditions: Polycystic Ovary Syndrome includes anovulatory hyperandrogenism, hyperinsulinemia and/or dyslipidemia. Adiponectin and interleukin-6 are adipocytokines that have been related to abdominal fat excess and/or impaired insulin sensitivity. These cytokines -together with other indices of low-grade inflammation-, sucj as C-reactive protein (CRP), and the neutrophil count, contribute to link insulin-resistant states with cardiovascular disease risks.

• Registration Number: EUCTR2005-004163-39-ES
• Lead Sponsor: Hospital Sant Joan de Déu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1-age 18 years or above
2-menarche at least 3 yr before study start
3-hyperandrogenism, either clinical (hirsutism, acne, menstrual disturbances) or biochemical (increased testosterone, decreased sex hormone-binding globulin, SHBG), or increase free androgen index).
4-hyperinsulinism: increase serum fasting insulin levels (15 uU/mL or more), decreased glucose/insulin ratio (<7), or increased insulin responses (>100 uU/mL) to an oral glucose overload.
5-dyslipidemia: decreased HDL-cholesterol; increased LDL-cholesterol and tryglicerides
6-neutrophilia (>3,7 x mm3); increased CRP (> 2mg/L).
7-normal liver, kidney and adrenal functions

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1-age less than 18
2-pregnancy
3-hyperprolactinemia, Cushing's syndrome, thyroid dysfunction, liver, kidney or adrenal disease, inflammatory bowel disease, family or personal history of diabetes mellitus or glucose intolerance, abnromal echocardiography
4-therapy with anti-androgens, estroprogestagens, antibiotics, or drugs interfering with glucose and lipid metabolism or gonadal function (over the last 6 mo)
5-alcoholism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and sfety of the addition of low-dose pioglitazone to flutamide-metformin treatment on the endocrine-metabolic profile, body composition, and inflammatory markers in young women with PCOS and cardiovascular risk.;Secondary Objective: ;Primary end point(s): Biochemical: <br>-decrease of 10% or more of CRP concentrations<br>-decrease of neutrophilia, adiponectin, free testosterone, insulin, free androgen index, LDL-cholesterol, triglycerides<br>-increase of SHBG, HDL-cholesterol<br><br>Body composition:<br>-decrease in abdominal fat mass of at least 10%