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

AGUNCO Obstetrics and Gynecology Centre

Status and phase

Completed

Phase 4

Conditions

PCOS

Treatments

Drug: Folic acid, vit B12

Dietary Supplement: Myo-inositol + Folic acid

Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12

Study type

Interventional

Funder types

Other

Identifiers

NCT01514942

MIvsDCI_PCOS/IR

Details and patient eligibility

About

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.

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women fulfilled two out of three diagnostic criteria for PCOS

Exclusion criteria

Women with pre-existing secondary endocrine disorders
Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
Women who received treatment with other drugs for the previous 6 months before entering the study.