NCT01514942

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: AGUNCO Obstetrics and Gynecology Centre · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• First posted: 2012-01-23
• Last updated: 2012-01-23

Locations

1 site across 1 country: Italy