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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01574261

Enrollment

Registered

2012-04-10

Start date

2012-03-31

Completion date

Unknown

Last updated

2012-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome, Cardiovascular risk, Metabolic Syndrome

Brief summary

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.

Interventions

DRUGPlacebo

Placebo for four months

DRUGInositol

Inositol 4g/die for four months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
CD4+ CD28 null T-lymphocyte frequency	five minutes

Secondary

Measure	Time frame
insulinaemic area OGTT AUCi, lipid profile, androgen levels	120 minutes

Countries

Italy

Contacts

Primary ContactRosanna Apa, M.D.; PhD

sandrina84@hotmail.com00390630155872

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026