Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.
N/A
18 Years
35 Years
18 Years
35 Years
Not Enrolling
Female
Polycystic Ovary Syndrome, Estro-progestin Drugs
Female
Polycystic Ovary Syndrome, Estro-progestin Drugs
Trial Information
Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.
Inclusion Criteria:
- normal weight women with Polycystic ovary syndrome, diagnosed in accordance with
Rotterdam Consensus Conference Criteria 2003.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women
Outcome Description:
hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile
Outcome Time Frame:
twelve months
Safety Issue:
Yes
Authority:
Italy: Catholic University of Sacred Heart
Study ID:
000102010
NCT ID:
NCT01519401
Start Date:
February 2010
Completion Date:
July 2011
Related Keywords:
- Polycystic Ovary Syndrome
- Estro-progestin Drugs
- PCOS
- drospirenone ethinylestradiol
- androgens
- metabolism
- Polycystic Ovary Syndrome
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