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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01555190

Enrollment

Registered

2012-03-15

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hirsutism, Menstrual Irregularity, Polycystic Ovary Syndrome

Keywords

myo-inositol, folic acid

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.

Interventions

DRUGmyo-inositol 1500 gr

DRUGmyo-inositol 2000 gr + folic acid 200 mcg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
effects on oral glucose tollerance test	six months
effects on hoormonal assay	6 months
effects oon lipide profile	6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026