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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01514942
First received: January 13, 2012
Last updated: January 18, 2012
Last verified: January 2012

January 13, 2012
January 18, 2012
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  • Body Mass Index (BMI)
  • Menstrual cycle
  • Score acne (acne grading system by Cremoncini et al)
  • Score hirsutism (Ferriman-Gallwey score)
  • Alopecia
  • Oral Glucose Tolerance Test (OGTT)
  • Glucagon levels
  • C-peptide test
  • Myo-inositol serum concentration
  • D-chiro-inositol serum concentration
  • Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
  • Prolactin (PRL) levels test
  • Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
  • Total and free testosterone levels
  • Sex hormone binding globulin (SHBG) test
  • 17-Hydroxyprogesterone (17-OHP) levels
  • Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
  • delta 4-androstenedione levels
  • progesterone levels
  • Adrenocorticotropic Hormone (ACTH) stimulation test
  • Ovarian size and morphology
    Ovarian ultrasound scan for the assessment of size and morphology
  • Antral follicle counts
  • Stromal/Cortical ratio in the ovary
  • Endometrial thickness
    Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.
Same as current
Complete list of historical versions of study NCT01514942 on ClinicalTrials.gov Archive Site
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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
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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.

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Interventional
Phase 4
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PCOS
  • 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)
  • Insulin resistant patients
    Interventions:
    • Dietary Supplement: Myo-inositol + Folic acid
    • Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12
    • Drug: Folic acid, vit B12
  • Non-insulin resistant patients
    Interventions:
    • Dietary Supplement: Myo-inositol + Folic acid
    • Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12
    • Drug: Folic acid, vit B12

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Female
20 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01514942
MIvsDCI_PCOS/IR
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AGUNCO Obstetrics and Gynecology Centre
AGUNCO Obstetrics and Gynecology Centre
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AGUNCO Obstetrics and Gynecology Centre
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP