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

This study is currently recruiting participants.
Verified March 2012 by Catholic University of the Sacred Heart
Sponsor:
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01555190
First received: March 13, 2012
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Hirsutism
Menstrual Irregularity
 Drug: myo-inositol 1500 gr
Drug: myo-inositol 2000 gr + folic acid 200 mcg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • number of cycles in six months of therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.


Secondary Outcome Measures:
  • effects on oral glucose tollerance test [ Time Frame: six months ] [ Designated as safety issue: No ]
  • effects on hoormonal assay [ Time Frame: 6 months ]
  • effects oon lipide profile [ Time Frame: 6 months ]

Estimated Enrollment: 50
Study Start Date: January 2012
Arms Assigned Interventions
Active Comparator: myo-inositol 1500 gr
6 months treatment with myo-inositol 1500 gr
 Drug: myo-inositol 1500 gr
Active Comparator: myo-inositol 2000gr + folic acid 200 mcg Drug: myo-inositol 2000 gr + folic acid 200 mcg

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555190

Contacts
Contact: Antonio Lanzone, professor 0039063057794

Locations
Italy
Catholic University of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Maurizio Guido, Medical Doctor     00390630156013     maurizioguido@libero.it    
Principal Investigator: Maurizio Guido, doctor            
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

No publications provided

Responsible Party: Maurizio Guido, medical doctor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01555190     History of Changes
Other Study ID Numbers: 000102012
Study First Received: March 13, 2012
Last Updated: March 14, 2012
Health Authority: Italy: Catholic University of Sacred Heart

Keywords provided by Catholic University of the Sacred Heart:
myo-inositol
folic acid

Additional relevant MeSH terms:
Hirsutism
Hypertrichosis
Polycystic Ovary Syndrome
Hair Diseases
Skin Diseases
Virilism
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Inositol
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013