Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
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|ClinicalTrials.gov Identifier: NCT01519401|
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : July 24, 2020
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||Phase|
|Polycystic Ovary Syndrome Estro-progestin Drugs||Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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|
|Actual Primary Completion Date :||July 2011|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519401
|Catholic University of Sacred Heart|
|Rome, Italy, 00168|