Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk. The aim of the study was to evaluate long-term effects of inositol on some cardiovascular risk factors in PCOS patients.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Inositol

Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment

Group Type ACTIVE_COMPARATOR

Inositol

Intervention Type DRUG

Inositol 4g/die for four months

Placebo

Patients will be randomized to receive placebo for four months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for four months

Interventions

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Placebo

Placebo for four months

Intervention Type DRUG

Inositol

Inositol 4g/die for four months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Polycystic Ovary Syndrome
* Age \>18 and \<35

Exclusion Criteria

* Chronic or acute inflammatory disease, cancer, autoimmune disease, treatment during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes