Status:

COMPLETED

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Contraception

Eligibility:

FEMALE

18-49 years

Phase:

PHASE3

Brief Summary

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.

Eligibility Criteria

Inclusion

  • Healthy women aged 18 to 49 years
  • Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1
  • Must be sexually active and at risk for becoming pregnant.

Exclusion

  • Planned use of any other form of birth control other than the test article.
  • Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
  • High blood pressure (defined as elevated sitting blood pressure: \> 140/90 mm Hg).

Key Trial Info

Start Date :

February 1 2003

Trial Type :

INTERVENTIONAL

End Date :

October 1 2005

Estimated Enrollment :

2000 Patients enrolled

Trial Details

Trial ID

NCT00245921

Start Date

February 1 2003

End Date

October 1 2005

Last Update

February 8 2013

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