Efficacy and Safety Study of an Oral Contraceptive in Healthy Females - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00206583

Purpose

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.

Condition	Intervention	Phase
Contraception	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label Uncontrolled Study to Investigate the Efficacy and Safety of a 4-Phasic Oral Contraceptive SH T0065 in a 28-Day Regimen for 13 Cycles in Healthy Female Subjects

Further study details as provided by Bayer:

Primary Outcome Measures:

Number of unintended pregnancies after 1 year [ Time Frame: Throughout 1 year of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bleeding pattern and cycle control parameters after 1 year [ Time Frame: Throughout 1 year of treatment ] [ Designated as safety issue: No ]

Enrollment:	583
Study Start Date:	March 2005
Study Completion Date:	July 2007

Arms	Assigned Interventions
Arm 1: Experimental n/a	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID) GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)

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

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy, lactation, and contraindication of combined oral contraceptive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206583

Show 29 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer HealthCare Pharmaceuticals, Inc ( Therapeutic Area Head )
Study ID Numbers:	90959, 304742
Study First Received:	September 12, 2005
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00206583 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Contraceptive Agents
Contraceptives, Oral
Contraceptive Agents, Female
Healthy
Dienogest

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009