NCT01574261

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

April 6, 2012

Last Update Submit

April 9, 2012

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromeCardiovascular riskMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • CD4+ CD28 null T-lymphocyte frequency

    five minutes

Secondary Outcomes (1)

  • insulinaemic area OGTT AUCi, lipid profile, androgen levels

    120 minutes

Study Arms (2)

Inositol

ACTIVE COMPARATOR

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

Drug: Inositol

Placebo

PLACEBO COMPARATOR

Patients will be randomized to receive placebo for four months

Drug: Placebo

Interventions

PlaceboDRUG

Placebo for four months

Placebo
InositolDRUG

Inositol 4g/die for four months

Inositol

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università cattolica S. Cuore

Rome, Rome, 00168, Italy

RECRUITING

Related Publications (1)

  • Niccoli G, Apa R, Lanzone A, Liuzzo G, Spaziani C, Sagnella F, Cosentino N, Moro F, Martinez D, Morciano A, Baca M, Pazzano V, Gangale MF, Tropea A, Crea F. CD4+CD28 null T lymphocytes are expanded in young women with polycystic ovary syndrome. Fertil Steril. 2011 Jun 30;95(8):2651-4. doi: 10.1016/j.fertnstert.2011.01.129. Epub 2011 Feb 16.

    PMID: 21324454RESULT

MeSH Terms

Conditions

Polycystic Ovary SyndromeMetabolic Syndrome

Interventions

Inositol

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Central Study Contacts

Rosanna Apa, M.D.; PhD

CONTACT

00390630155872sandrina84@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2012

First Posted

April 10, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

IT(1)