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
• Sponsor: Catholic University of the Sacred Heart
• Information provided by (Responsible Party): Maurizio Guido, Catholic University of the Sacred Heart

Tracking Information

• First Submitted Date: January 23, 2012
• First Posted Date: January 26, 2012
• Last Update Posted Date: January 26, 2012
• Study Start Date: February 2010
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: January 23, 2012)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Polycystic Ovary Syndrome
• Estro-progestin Drugs

Intervention

• Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol
• Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol

Study Arms

• Active Comparator: 3 mg drospirenone and 20 µg ethinyl-estradiol
  Intervention: Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol
• Active Comparator: 3 mg drospirenone and 30 µg ethinyl-estradiol
  Intervention: Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2011
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01519401
• Other Study ID Numbers: 000102010
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Maurizio Guido, Catholic University of the Sacred Heart
• Study Sponsor: Catholic University of the Sacred Heart
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Catholic University of the Sacred Heart
• Verification Date: January 2012