Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome | RxWiki

Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome

Overview[ - collapse ][ - ]

Purpose	To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients
Condition	Polycystic Ovary Syndrome
Intervention	Drug: Metformin Drug: Yasmin; Drug: Metformin plus Yasmin
Phase	Phase 3
Sponsor	Catholic University of the Sacred Heart
Responsible Party	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier	NCT01581814
First Received	April 19, 2012
Last Updated	April 19, 2012
Last verified	April 2012

Tracking Information[ + expand ][ + ]

First Received Date	April 19, 2012
Last Updated Date	April 19, 2012
Start Date	October 2008
Estimated Primary Completion Date	March 2012
Current Primary Outcome Measures	CD4+CD28null frequency [Time Frame: five minutes] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	the area under the curve for insulin (AUCi) and lipid profile. [Time Frame: 120 minutes] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
Official Title	Not Provided
Brief Summary	To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients
Detailed Description	Polycystic ovary syndrome (PCOS), one of the most common endocrine disorders affecting women on reproductive age , seems to be associated with an increased incidence of cardiovascular disease. At present, insulin-sensitizing drugs, such as metformin, represent one of the most important line treatment for hyperinsulinemic PCOS women. Metformin is able to produce favourable outcomes on the metabolic derangements in insulin-resistant normal weight and obese PCOS patients. Oral contraceptives represent the traditional medical therapy for the long-term treatment of PCOS women, in order to obtain regular menstrual cycles and to improve the clinical signs of hyperandrogenism.Based on the above mentioned evidences, the aim of the present study was to evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic PCOS patients
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Polycystic Ovary Syndrome
Intervention	Drug: Metformin 500 mg of Metformin per 3/die Drug: Yasmin; 1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days) Drug: Metformin plus Yasmin 0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily
Study Arm (s)	Active Comparator: Metformin 31 subjects were randomized to receive 500 mg Metformin per 3/die Active Comparator: 0.03 mg EE plus 3 mg of DRPS Active Comparator: Metformin plus Yasmin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	99
Estimated Completion Date	March 2012
Estimated Primary Completion Date	July 2011
Eligibility Criteria	Inclusion Criteria: - age 18-35 - hyperinsulinemic PCOS Exclusion Criteria: - chronic or acute inflammatory disease, cancer, autoimmune disease, treatment with clomiphene citrate, oral contraceptives, antiandrogens, drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Italy

Administrative Information[ + expand ][ + ]

NCT Number	NCT01581814
Other Study ID Numbers	disfunzionale14
Has Data Monitoring Committee	Yes
Information Provided By	Catholic University of the Sacred Heart
Study Sponsor	Catholic University of the Sacred Heart
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	April 2012

Locations[ + expand ][ + ]