Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

NCT ID: NCT00206583

Last Updated: 2014-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

499 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Contraception

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EV/DNG (Qlaira, BAY86-5027)

Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)

Group Type EXPERIMENTAL

EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Intervention Type DRUG

GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)

Interventions

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EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy, lactation, and contraindication of combined oral contraceptive
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Women and Children's Hospital, Los Angeles

Los Angeles, California, United States

Site Status

Lifespan Research

Palo Alto, California, United States

Site Status

Genesis Center for Clinical Research

San Diego, California, United States

Site Status

Medical Center for Clinical Research

San Diego, California, United States

Site Status

Harbor - UCLA Medical Center

Torrance, California, United States

Site Status

Clinical Trial Center of Colorado

Castle Rock, Colorado, United States

Site Status

New Age Medical Research Corp.

Miami, Florida, United States

Site Status

Visions Clinical Research

Palm Springs, Florida, United States

Site Status

Insignia Care for Women, P.A.

Tampa, Florida, United States

Site Status

Comprehensive Clinical Trials

West Palm Beach, Florida, United States

Site Status

Physicians Research Group

Indianapolis, Indiana, United States

Site Status

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, United States

Site Status

Women's Care Source

Morristown, New Jersey, United States

Site Status

OB/GYN Health Center

Medford, Oregon, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, United States

Site Status

Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, United States

Site Status

Total Concept Health Care Inc.

Kitchener, Ontario, Canada

Site Status

Temple Green Clinic

Waterloo, Ontario, Canada

Site Status

Rhodin Recherche Clinique

Drummondville, Quebec, Canada

Site Status

Centre d'étude clinique de Montréal Inc.

Montreal, Quebec, Canada

Site Status

Les Gynecologues Associes

Montreal, Quebec, Canada

Site Status

Clinique Recherche en Sante des Femmes Inc.

Québec, Quebec, Canada

Site Status

Clinique de Gynecologie

Shawinigan, Quebec, Canada

Site Status

Diex Recherche Inc.

Sherbrooke, Quebec, Canada

Site Status

Clinique Médicale des Campus

Ste-Foy, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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304742

Identifier Type: OTHER

Identifier Source: secondary_id

90959

Identifier Type: -

Identifier Source: org_study_id

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