Status:

WITHDRAWN

Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Contraception

Eligibility:

FEMALE

18-35 years

Phase:

PHASE1

Brief Summary

Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparatio...

Eligibility Criteria

Inclusion

  • Women aged 18 to 35 years.
  • Healthy as determined by the investigator on the basis of medical history and screening evaluations.
  • Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.

Exclusion

  • Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
  • Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
  • Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.

Key Trial Info

Start Date :

August 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2007

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00447863

Start Date

August 1 2007

End Date

August 1 2007

Last Update

August 20 2021

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Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women | DecenTrialz