Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

Polycystic Ovary Syndrome Clinical Trial

Official title:

Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555190
• Other study ID #: 000102012
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2020
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003

• BMI > 25 kg/m2

• age 18-35 years

Exclusion Criteria:

• pregnancy

• significant liver or renal impairment

• other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)

• neoplasms

• unstable mental illness

• diagnosis of diabetes mellitus or impaired glucose tolerance

• use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior entering the study.

Related Conditions & MeSH terms

• Hirsutism
• Menstrual Irregularity
• Menstruation Disturbances
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• myo-inositol 1500 gr

• myo-inositol 2000 gr + folic acid 200 mcg

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of cycles in six months of therapy	We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.	6 months
Secondary	effects on oral glucose tollerance test		six months
Secondary	effects on hoormonal assay		6 months
Secondary	effects oon lipide profile		6 months