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Clinical Trials/EUCTR2005-004163-39-ES
EUCTR2005-004163-39-ES
Active, not recruiting
Not Applicable

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

Hospital Sant Joan de Déu0 sites40 target enrollmentOctober 5, 2005
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ConditionsPolycystic 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.
DrugsActos (Pioglitazone)Dianben (Metformin)Flutamide (Flutamide)

Overview

Phase
Not Applicable
Intervention
Not specified
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.
Sponsor
Hospital Sant Joan de Déu
Enrollment
40
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 5, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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