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
N/A
18 Years
35 Years
18 Years
35 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Hirsutism, Menstrual Irregularity
Female
Polycystic Ovary Syndrome, Hirsutism, Menstrual Irregularity
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
number of cycles in six months of therapy
Outcome Description:
We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
Italy: Catholic University of Sacred Heart
Study ID:
000102012
NCT ID:
NCT01555190
Start Date:
January 2012
Completion Date:
Related Keywords:
- Polycystic Ovary Syndrome
- Hirsutism
- Menstrual Irregularity
- myo-inositol
- folic acid
- Hirsutism
- Hypertrichosis
- Polycystic Ovary Syndrome
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