A phase 3 multicenter open label study to evaluate the safety and efficacy of Levonorgestrel 90ug and ethinyl estradiol 20ug in a continuous daily regimen for oral contraception

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Investigator: Philip D. Darney, MD, MS
Sponsor: Wyeth

Location(s): United States

Description

To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.

 Primary Outcome Measures:
  • To evaluate safety and contraceptive efficacy

Secondary Outcome Measures:
  • To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline.