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Status unknownNCT01574261Updated Apr 10, 2012

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

An Early Phase 1 interventional study of Placebo and Inositol in Polycystic Ovary Syndrome, sponsored by Catholic University of the Sacred Heart. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-10.

Sponsored by Catholic University of the Sacred Heart · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Polycystic Ovary Syndrome
  • Cardiovascular risk
  • Metabolic Syndrome
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.

Browse Catholic University of the Sacred Heart studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Inositol

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

    Drug: Inositol

  • Placebo comparator
    Placebo

    Patients will be randomized to receive placebo for four months

    Drug: Placebo

Interventions

  • DrugPlacebo

    Placebo for four months

  • DrugInositol

    Inositol 4g/die for four months

06

What researchers measure

Primary outcomes

  1. CD4+ CD28 null T-lymphocyte frequency

    Time frame: five minutes

Secondary outcomes

  1. insulinaemic area OGTT AUCi, lipid profile, androgen levels

    Time frame: 120 minutes

07

Study locations

1 of 1 sites recruiting
  • Università cattolica S. Cuore
    Rome, Rome 00168, Italy
    Recruiting
08

References and documents

Publications

  • 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. PubMed 21324454 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2012 and a primary completion of Aug 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2012
First posted
Apr 10, 2012
Start
Mar 2012
Primary completionEst.
Aug 2012
Last update
Apr 10, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01574261
Lead sponsor
Catholic University of the Sacred Heart
Responsible party
Rosanna Apa (Professor, Catholic University of the Sacred Heart) — Principal investigator
First posted
Apr 10, 2012
Start date
Mar 2012
Primary completion
Aug 2012 (estimated)
Last update
Apr 10, 2012

Study contacts

Rosanna Apa, M.D.; PhD
Contact
sandrina84@hotmail.com
00390630155872

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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