This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier:
NCT01626443
First received: June 15, 2012
Last updated: February 13, 2017
Last verified: February 2017
June 15, 2012
February 13, 2017
January 2014
June 2015   (Final data collection date for primary outcome measure)
  • Menstrual cycle restoration [ Time Frame: At 6 months ]
  • Score hirsutism (Ferriman-Gallwey classification) [ Time Frame: At 6 months ]
  • Serum progesterone [ Time Frame: At 6 months ]
  • Testosterone level test [ Time Frame: At 6 months ]
  • Oral glucose tolerance test (OGTT) [ Time Frame: At 6 months ]
    Evaluation of glycemia and insulinemia levels
  • Homeostasis Model Assessment (HOMA-index) [ Time Frame: At 6 months ]
  • Sex hormone binding globulin (SHBG) test [ Time Frame: At 6 months ]
  • Androstenediol level test [ Time Frame: At 6 months ]
  • Androstenedione level test [ Time Frame: At 6 months ]
  • Free Androgen Index (FAI) level test [ Time Frame: At 6 months ]
  • Menstrual cycle restoration
  • Score hirsutism (Ferriman-Gallwey classification)
  • Serum progesterone
  • Testosterone level test
  • Oral glucose tolerance test (OGTT)
    Evaluation of glycemia and insulinemia levels
  • Homeostasis Model Assessment (HOMA-index)
  • Sex hormone binding globulin (SHBG) test
  • Androstenediol level test
  • Androstenedione level test
  • Free Androgen Index (FAI) level test
Complete list of historical versions of study NCT01626443 on ClinicalTrials.gov Archive Site
  • Body Mass Index (BMI) [ Time Frame: At 6 months ]
  • Change from baseline in diastolic blood pressure levels [ Time Frame: At 6 months ]
  • Change from baseline in systolic blood pressure levels [ Time Frame: At 6 months ]
  • Number of patients with abnormal ovarian size and morphology [ Time Frame: At 6 months ]
    Ovarian ultrasound scan for the assessment of size and morphology
  • Luteinizing Hormone (LH) level test [ Time Frame: At 6 months ]
    Analysis of LH levels should be performed between the 7th and the 10th day of the cycle
  • Follicle Stimulating Hormone (FSH) level test [ Time Frame: At 6 months ]
    Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle
  • Estradiol (E2) level test [ Time Frame: At 6 months ]
    Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle
  • Body Mass Index (BMI) [ Time Frame: three and six months ]
  • Change from baseline in diastolic blood pressure levels [ Time Frame: three and six months ]
  • Change from baseline in systolic blood pressure levels [ Time Frame: three and six months ]
  • Number of patients with abnormal ovarian size and morphology
    Ovarian ultrasound scan for the assessment of size and morphology
  • Luteinizing Hormone (LH) level test
    Analysis of LH levels should be performed between the 7th and the 10th day of the cycle
  • Follicle Stimulating Hormone (FSH) level test
    Analysis of FSH levels should be performed between the 7th and the 10th day of the cycle
  • Estradiol (E2) level test
    Analysis of E2 levels should be performed between the 7th and the 10th day of the cycle
Not Provided
Not Provided
 
Role of Myo-inositol and D-chiro Inositol on the Ovaric and Metabolic Functions
Not Provided

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is characterized by menstrual abnormalities, clinical or biochemical hyperandrogenism, multiple abnormal cysts and enlarge ovaries. Women affected by PCOS often suffer of insulin resistance and of a compensatory hyperinsulinemia which put them at risk of developing several metabolic disorders. Inositol is a six-carbon polyol which has been characterized as an insulin sensitizer: it exists as nine different isomers and among them myo-inositol and D-chiroinositol are the most represented and studied in physiology and physiopathology. In particular, myo-inositol (MI) and D-chiro inositol (DCI) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels.

The aim of this randomized study is to evaluate the metabolic and ovaric effects of a six-month supplementation of myo-inositol and D-chiro-inositol on young women with PCOS and hyperinsulemia.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
PCOS
  • Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid
    Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die
  • Dietary Supplement: Folic acid
    Folic acid (200 mcg); 2 x die
  • Active Comparator: Folic acid
    Intervention: Dietary Supplement: Folic acid
  • Experimental: Inofolic Combi
    Intervention: Dietary Supplement: Myo-inositol + D-chiro-inositol + Folic acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • PCOS
  • Women aged between 14-40 years
  • BMI > 28
  • Hyperinsulinemia

Exclusion Criteria:

  • Pre-existing secondary endocrine and metabolic disorders
  • Pre-existing secondary adrenal disorders
  • Pharmacologic treatment in the last 3 months before entering the study
  • Pregnancy
Sexes Eligible for Study: Female
14 Years to 40 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01626443
MI-DCI
Not Provided
Not Provided
Not Provided
Not Provided
Lo.Li.Pharma s.r.l
Lo.Li.Pharma s.r.l
Not Provided
Not Provided
Lo.Li.Pharma s.r.l
February 2017

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