CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 46 enrolled
Drug / intervention
Myo-inositol + D-chiro-inositol + Folic acid +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01626443
NCT01626443Phase 4Completed

Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions

Lo.Li.Pharma s.r.l·interventional·Posted Jun 22, 2012·Updated Feb 14, 2017

In Brief

A Phase 4 clinical trial evaluating Myo-inositol + D-chiro-inositol + Folic acid and Folic acid for PCOS. Completed, enrolled 46 participants across 1 site.

Detailed Summary

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of developing several metabolic disorders. Inositol is a six-carbon polyol which has been characterized as an insulin sensitizer: it exists as nine different isomers and among them myo-inositol and D-chiroinositol are the most represented and studied in physiology and physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels. The aim of this randomized study is to evaluate the metabolic and ovaric effects of a six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and hyperinsulemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPCOS
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2012
Enrollment StartJan 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.0 years ago

Interventions

Myo-inositol + D-chiro-inositol + Folic aciddietary

Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die

Folic aciddietary

Folic acid (200 mcg); 2 x die