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Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women

NCT00842140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2010-07-22

No results posted yet for this study

Summary

The purpose of this study to assess early markers of cardiovascular disease in women with polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and chlormadinone acetate alone or associated with Spironolactone.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

oral contraceptive

oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months

DRUG

Oral contraceptive plus spironolactone

The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.

DRUG

Oral contraceptive plus metformin

Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Rui A Ferriani, MD, PhD · University of Sao Paulo

  • Marcos Felipe S de Sa, MD, PhD · University of Sao Paulo

  • Carolina S Vieira, MD, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Brazil

Study Locations

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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 NCT00842140 on ClinicalTrials.gov