Spots Global Cancer Trial Database for Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.

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Trial Identification

Brief Title: Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.

Official Title: 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.

Study ID: NCT01519401

Conditions

Polycystic Ovary Syndrome

Estro-progestin Drugs

Interventions

3 mg drospirenone and 20 µg ethinyl-estradiol

3 mg drospirenone and 30 µg ethinyl-estradiol

Study Description

Brief Summary: The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS). The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.

Detailed Description: