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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
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.
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.
Age
18 - 35 years
Sex
FEMALE
Healthy Volunteers
Yes
Women and Children's Hospital, Los Angeles
Los Angeles, California, United States
Lifespan Research
Palo Alto, California, United States
Genesis Center for Clinical Research
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Harbor - UCLA Medical Center
Torrance, California, United States
Clinical Trial Center of Colorado
Castle Rock, Colorado, United States
New Age Medical Research Corp.
Miami, Florida, United States
Visions Clinical Research
Palm Springs, Florida, United States
Insignia Care for Women, P.A.
Tampa, Florida, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, United States
Start Date
March 1, 2005
Primary Completion Date
June 1, 2007
Completion Date
July 1, 2007
Last Updated
October 1, 2014
499
ACTUAL participants
EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
DRUG
Lead Sponsor
Bayer
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06672016