Status:

COMPLETED

Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

Lead Sponsor:

Bayer

Conditions:

Contraception

Eligibility:

FEMALE

18-35 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.

Detailed Description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.

Eligibility Criteria

Inclusion

  • Healthy women between the ages of 18 and 35 years requiring contraception

Exclusion

  • Pregnancy, lactation, and contraindication of combined oral contraceptive

Key Trial Info

Start Date :

March 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

499 Patients enrolled

Trial Details

Trial ID

NCT00206583

Start Date

March 1 2005

End Date

July 1 2007

Last Update

October 1 2014

Active Locations (29)

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Page 1 of 8 (29 locations)

1

Women and Children's Hospital, Los Angeles

Los Angeles, California, United States, 90033

2

Lifespan Research

Palo Alto, California, United States, 94301

3

Genesis Center for Clinical Research

San Diego, California, United States, 92103

4

Medical Center for Clinical Research

San Diego, California, United States, 92108