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

Catholic University of the Sacred Heart

Status and phase: Unknown; Early Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo; Drug: Inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT01574261

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Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Inositol

Active Comparator group

Description:

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

Treatment:

Drug: Inositol

Placebo

Placebo Comparator group

Description:

Patients will be randomized to receive placebo for four months

Treatment:

Drug: Placebo