Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
NCT ID: NCT01519401
Last Updated: 2020-07-24
Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2010-02-28
2011-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3 mg drospirenone and 20 µg ethinyl-estradiol
3 mg drospirenone and 20 µg ethinyl-estradiol
3 mg drospirenone and 30 µg ethinyl-estradiol
3 mg drospirenone and 30 µg ethinyl-estradiol
Interventions
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3 mg drospirenone and 20 µg ethinyl-estradiol
3 mg drospirenone and 30 µg ethinyl-estradiol
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Maurizio Guido
medical doctor
Locations
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Catholic University of Sacred Heart
Rome, , Italy
Countries
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References
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Romualdi D, De Cicco S, Busacca M, Gagliano D, Lanzone A, Guido M. 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. J Endocrinol Invest. 2013 Sep;36(8):636-41. doi: 10.1007/BF03346756.
Other Identifiers
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000102010
Identifier Type: -
Identifier Source: org_study_id
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