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Trial record 73 of 107 for:    "21-hydroxylase deficiency"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02651636
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Menstrual Pattern Hyperandrogenism Metabolic Features Drug: myo-inositol,alpha-lipoic acid and folic acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2014
Actual Primary Completion Date : July 2015

Arm Intervention/treatment
Experimental: Open label
Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months
Drug: myo-inositol,alpha-lipoic acid and folic acid

Primary Outcome Measures :
  1. Number of cycles in six months of therapy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart Identifier: NCT02651636     History of Changes
Other Study ID Numbers: 000102014
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Adrenogenital Syndrome
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Folic Acid
Vitamin B Complex
Thioctic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action