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NCT Number: NCT01555190

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hair Diseases Hirsutism Menstrual Irregularity Menstruation Disturbances Neoplasms Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Virilism

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Sacred Heart

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

myo-inositol 1500 gr

Drug

myo-inositol 2000 gr + folic acid 200 mcg

Drug

Primary outcomes

  1. number of cycles in six months of therapy

    Time frame: 6 months

    We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.

Secondary outcomes

  1. effects on oral glucose tollerance test

    Time frame: six months

  2. effects on hoormonal assay

    Time frame: 6 months

  3. effects oon lipide profile

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2012
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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