Clinical trial NCT00206583: Efficacy and Safety Study of an Oral Contraceptive in Healthy Females
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 499
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 Criteria:

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

Exclusion Criteria:

* Pregnancy, lactation, and contraindication of combined oral contraceptive

Primary outcomes:
measure: Number of unintended pregnancies after 1 year
timeFrame: Throughout 1 year of treatment
Secondary outcomes:
measure: Bleeding pattern and cycle control parameters after 1 year
timeFrame: Throughout 1 year of treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Women and Children's Hospital, Los Angeles
state: California
city: Palo Alto
country: United States
facility: Lifespan Research
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Medical Center
state: California
city: Castle Rock
country: United States
facility: Clinical Trial Center of Colorado
state: Colorado
city: Miami
country: United States
facility: New Age Medical Research Corp.
state: Florida
city: Palm Springs
country: United States
facility: Visions Clinical Research
state: Florida
city: Tampa
country: United States
facility: Insignia Care for Women, P.A.
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials
state: Florida
city: Indianapolis
country: United States
facility: Physicians Research Group
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Morristown
country: United States
facility: Women's Care Source
state: New Jersey
city: Medford
country: United States
facility: OB/GYN Health Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Health System
state: Pennsylvania
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
city: Kitchener
country: Canada
facility: Total Concept Health Care Inc.
state: Ontario
city: Waterloo
country: Canada
facility: Temple Green Clinic
state: Ontario
city: Drummondville
country: Canada
facility: Rhodin Recherche Clinique
state: Quebec
city: Montreal
country: Canada
facility: Centre d'étude clinique de Montréal Inc.
state: Quebec
city: Montreal
country: Canada
facility: Les Gynecologues Associes
state: Quebec
city: Shawinigan
country: Canada
facility: Clinique de Gynecologie
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Inc.
state: Quebec
city: Ste-Foy
country: Canada
facility: Clinique Médicale des Campus
state: Quebec
city: Quebec
country: Canada
facility: Clinique Recherche en Sante des Femmes Inc.
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: