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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/25706
• EU PAS number:
  EUPAS25705
• Study ID:
  25706
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  AbstractBackground. 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.Design. Prospective clinical study.Setting. PCOS patients in a clinical research environment.Patients. Seventy women diagnosed with PCOS according to Rotterdam criteria were enrolled in this study.Interventions. Patients received combined therapy of one tablet that contained 550 mg of inositol (myo-inositol (MI) and D-chiro-inositol (DCI) in a ratio of 10:1), 200 μg of folic acid, 500 IU of vitamin D, 0.7 mg of vitamin B6, 3 mg of vitamin B5, 1.25 μg of vitamin B12 twice a day for 6 months. At each visit, the body weight, height and BMI were all recorded, and serum levels of free testosterone (fT), sex hormone-binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH) and glucose with insulin during standard OGTT (75 g) were all measured as well. Moreover transvaginal ultrasonography and skin condition assessment were performed at each visit. Results. Significant body weight reduction and decrease in fT, FSH, LH and insulin levels as well as significant increase of serum SHBG concentration were observed. Serum glucose levels during OGTT decreased after 6 months of treatment. Also skin conditions improved after just three months of treatment.Conclusions. Combination of MI and DCI in a ratio 10:1 seems to be efficient in improving both metabolic and hormonal parameters in PCOS patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Center of Reproductive Health, Institute of Mother and Child, Warsaw

Study timelines

Date when funding contract was signed

Actual: 08/10/2014

Study start date

Actual: 08/01/2015

Data analysis start date

Actual: 20/09/2017

Date of final study report

Actual: 05/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Verco

Study protocol

Initial protocol

Subjects and study design

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable