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

NCT01555190 | Completed

• 1 other identifier: 000102012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Hirsutism; Menstrual Irregularity

Keywords

myo-inositol; folic acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• effects on oral glucose tollerance test

  six months

• effects on hoormonal assay

  6 months

• effects oon lipide profile

  6 months

Study Arms (2)

myo-inositol 1500 gr

ACTIVE COMPARATOR

6 months treatment with myo-inositol 1500 gr

Drug: myo-inositol 1500 gr

myo-inositol 2000gr + folic acid 200 mcg

ACTIVE COMPARATOR

Drug: myo-inositol 2000 gr + folic acid 200 mcg

Interventions

myo-inositol 1500 gr DRUG

myo-inositol 1500 gr

myo-inositol 2000 gr + folic acid 200 mcg DRUG

myo-inositol 2000gr + folic acid 200 mcg

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
• BMI \> 25 kg/m2
• age 18-35 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hirsutism; Menstruation Disturbances

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 24, 2020

Record last verified: 2020-07

Locations

IT (1)