Metabolic and hormonal effects of Myoinositol and D-chiro-inositol the combined therapy with polycystic ovary syndrome (PCOS) patients (Myoinositol and D-chiro-inositol in PCOS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Clinical trial

Clinical trials

• Clinical trial randomisation:
  Non-randomised clinical trial

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  INOSITOL

  FOLIC ACID

  PYRIDOXINE

  VITAMIN D

  VITAMIN B12

  PANTOTHENIC ACID
• Medical condition to be studied:
  Polycystic ovaries

Population studied

• Short description of the study population:
  Women patients diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria.
• Age groups:
  Adults (18 to < 46 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Polycystic ovary syndrome (PCOS) patients
• Estimated number of subjects:
  70

Study design details

• Main study objective:
  To evaluate the effects of the combined therapy with Myo-inositol (MI) and D-chiro-inositol (DCI) on hormonal and metabolic parameters of women with PCOS
• Outcomes:
  body weight reduction fT, FSH, LH and insulin levels serum SHBG Serum glucose levels during OGTT after 6 months of treatment
• Data analysis plan:
  Quantitive data are presented as mean±SD. Wilcoxon test was used to determine whether the differences (both between the first and the second visit and between the first and the third visit) are statistically significant and a Bonferroni correction for multiple comparisons was applied. The significance level was set at 0.05/2=0.025. The percentage distribution was presented for qualitive data, such as skin condition, at the second and the third visit in relation to the first visit. To determine whether the data distribution differences were statistically significant, the Χ2 test was used and when the expected frequency in any cell was less than 5 the Fisher's Exact Test was applied. The significance level was set at α=0.05.

Documents

Study results

Study results_EUPAS25705

Study publications

Carlomagno G, Nordio M, Chiu TT, Unfer V. Contribution of myo-inositol and mela…

Abdelhamid AM, Madkour WA, Borg TF. Inositol versus metformin administration in…

Artini PG, Di Berardino OM, Papini F, Genazzani AD, Simi G, Ruggiero M, Cela V…

Bevilacqua A, Carlomagno G, Gerli S, Montanino Oliva M, Devroey P, Lanzone A, S…

Nordio M, Proietti E. The combined therapy with myo-inositol and D-chiro-inosit…

Minozzi M, Nordio M, Pajalich R. The Combined therapy myo-inositol plus D-Chiro…