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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Hirsutism; Menstrual Irregularity
• Interventions: Drug: myo-inositol 1500 gr; Drug: myo-inositol 2000 gr + folic acid 200 mcg

• Registration Number: NCT01555190
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
myo-inositol 1500 gr	myo-inositol 1500 gr	6 months treatment with myo-inositol 1500 gr
myo-inositol 2000gr + folic acid 200 mcg	myo-inositol 2000 gr + folic acid 200 mcg	-

Primary Outcome Measures

Name	Time	Method
number of cycles in six months of therapy	6 months	We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.

Secondary Outcome Measures

Name	Time	Method
effects oon lipide profile	6 months
effects on oral glucose tollerance test	six months
effects on hoormonal assay	6 months

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy