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Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters

NCT01514942 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2012-01-23

No results posted yet for this study

Summary

Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.

Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug.

In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported.

In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.

Conditions

  • PCOS

Interventions

DIETARY_SUPPLEMENT

Myo-inositol + Folic acid

Myo-inositol (2g) Folic acid (200mcg) (2 per day)

DIETARY_SUPPLEMENT

Myo-inositol + Folic acid

Myo-inositol (2g) Folic acid (200mcg) (2 per day)

DIETARY_SUPPLEMENT

D-chiro-inositol, manganese, folic acid, vit B12

D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)

DIETARY_SUPPLEMENT

D-chiro-inositol, manganese, folic acid, vit B12

D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)

DRUG

Folic acid, vit B12

Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)

DRUG

Folic acid, vit B12

Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)

Sponsors & Collaborators

  • AGUNCO Obstetrics and Gynecology Centre

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01514942 on ClinicalTrials.gov