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

NCT01581814 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2012-04-20

No results posted yet for this study

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

Conditions

  • Polycystic Ovary Syndrome

Interventions

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

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-07-31
Completion
2012-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01581814 on ClinicalTrials.gov