Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
|ClinicalTrials.gov Identifier: NCT01519401|
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : January 26, 2012
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.
|Condition or disease||Intervention/treatment|
|Polycystic Ovary Syndrome Estro-progestin Drugs||Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2010|
|Study Completion Date :||July 2011|
|Active Comparator: 3 mg drospirenone and 20 µg ethinyl-estradiol||Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol|
|Active Comparator: 3 mg drospirenone and 30 µg ethinyl-estradiol||Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol|
- To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women [ Time Frame: twelve months ]hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519401
|Catholic University of Sacred Heart|
|Rome, Italy, 00168|