Efficacy and Safety Study of an Oral Contraceptive in Healthy Females
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
2 other identifiers
interventional
499
2 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2005
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedOctober 1, 2014
September 1, 2014
2.3 years
September 12, 2005
September 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of unintended pregnancies after 1 year
Throughout 1 year of treatment
Secondary Outcomes (1)
Bleeding pattern and cycle control parameters after 1 year
Throughout 1 year of treatment
Study Arms (1)
EV/DNG (Qlaira, BAY86-5027)
EXPERIMENTALEstradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)
Interventions
GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)
Eligibility Criteria
You may qualify if:
- Healthy women between the ages of 18 and 35 years requiring contraception
You may not qualify if:
- Pregnancy, lactation, and contraindication of combined oral contraceptive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (29)
Women and Children's Hospital, Los Angeles
Los Angeles, California, 90033, United States
Lifespan Research
Palo Alto, California, 94301, United States
Genesis Center for Clinical Research
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Harbor - UCLA Medical Center
Torrance, California, 90509, United States
Clinical Trial Center of Colorado
Castle Rock, Colorado, 80108, United States
New Age Medical Research Corp.
Miami, Florida, 33186, United States
Visions Clinical Research
Palm Springs, Florida, 33461, United States
Insignia Care for Women, P.A.
Tampa, Florida, 33607, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409, United States
Physicians Research Group
Indianapolis, Indiana, 46250, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510, United States
Women's Care Source
Morristown, New Jersey, 07960, United States
OB/GYN Health Center
Medford, Oregon, 97504, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213-2582, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105, United States
Total Concept Health Care Inc.
Kitchener, Ontario, N2C 2N9, Canada
Temple Green Clinic
Waterloo, Ontario, N2L 6H6, Canada
Rhodin Recherche Clinique
Drummondville, Quebec, J2B 1H8, Canada
Centre d'étude clinique de Montréal Inc.
Montreal, Quebec, H1T 1P6, Canada
Les Gynecologues Associes
Montreal, Quebec, H2X 1N8, Canada
Clinique Recherche en Sante des Femmes Inc.
Québec, Quebec, G1S 2L6, Canada
Clinique de Gynecologie
Shawinigan, Quebec, G9N 2H6, Canada
Diex Recherche Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Clinique Médicale des Campus
Ste-Foy, Quebec, G1V 4X7, Canada
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 21, 2005
Study Start
March 1, 2005
Primary Completion
June 1, 2007
Study Completion
July 1, 2007
Last Updated
October 1, 2014
Record last verified: 2014-09