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Completed

NCT Number: NCT02651636

Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women

The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.

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Key information

Conditions

Polycystic Ovary Syndrome 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hyperandrogenism Male Urogenital Diseases Menstrual Pattern Metabolic Features Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Abnormalities Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women with PCOS in accordance with Rotterdam criteria

Exclusion criteria

  • pregnancy
  • past history of cardiovascular disease,
  • diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test),
  • hypertension,
  • significant liver or renal impairment,
  • other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs),
  • neoplasms,
  • unstable mental illness.

Treatment and study plan

myo-inositol,alpha-lipoic acid and folic acid

Drug

Primary outcomes

  1. Number of cycles in six months of therapy

    Time frame: 6 months

Secondary outcomes

  1. Hirsutism

    Time frame: 6 months

    Ferriman Gallwey score

  2. Hyperandrogenism

    Time frame: 6 months

    Testosterone, Androstenedione, free androgen index

  3. Insulin response to oral glucose tolerance test

    Time frame: 6 months

  4. Lipidic profile

    Time frame: 6 months

    Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

Effects of Combined Therapy With Myo-inositol and Alpha-Lipoic Acid on Clinical, Endocrine and Metabolic Features in Women Affected by Polycystic Ovary Syndrome

Important dates

Study start
2014
Primary completion
2015
First posted
Jan 11, 2016
Registry last updated
Jan 11, 2016

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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