Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PCOS Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Istituto di Patologia Ostetrica e Ginecologica

Catania, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Myo-inositol + Folic acid

Dietary Supplement

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

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

Dietary Supplement

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

Folic acid, vit B12

Drug

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

Primary outcomes

  1. Body Mass Index (BMI)

  2. Menstrual cycle

  3. Score acne (acne grading system by Cremoncini et al)

  4. Score hirsutism (Ferriman-Gallwey score)

  5. Alopecia

  6. Oral Glucose Tolerance Test (OGTT)

  7. Glucagon levels

  8. C-peptide test

  9. Myo-inositol serum concentration

  10. D-chiro-inositol serum concentration

  11. Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test

  12. Prolactin (PRL) levels test

  13. Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test

  14. Total and free testosterone levels

  15. Sex hormone binding globulin (SHBG) test

  16. 17-Hydroxyprogesterone (17-OHP) levels

  17. Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels

  18. delta 4-androstenedione levels

  19. progesterone levels

  20. Adrenocorticotropic Hormone (ACTH) stimulation test

  21. Ovarian size and morphology

    Ovarian ultrasound scan for the assessment of size and morphology

  22. Antral follicle counts

  23. Stromal/Cortical ratio in the ovary

  24. Endometrial thickness

    Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.

Sponsors and collaborators

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre

Other

Registry information

Important dates

First posted
Jan 23, 2012
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.