Clinical trial NCT00362479: Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
Official title: A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: pregnancy prevention
oral contraceptives
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-10
Enrollment: 1347
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Detailed description: The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

Eligibility criteria: Inclusion Criteria:

* Premenopausal
* Not pregnant or breastfeeding
* Sexually active at risk of pregnancy

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy within the last 3 months
* Smoking \> 10 cigarettes per day

Primary outcomes:
measure: Evaluation of pregnancy rates
timeFrame: Duration of study
Secondary outcomes:
measure: Adverse events reported by patients and investigators
timeFrame: Duration of study
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Carmichael
country: United States
facility: Duramed Investigational Site
state: California
city: Irvine
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Ramon
country: United States
facility: Duramed Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Wilmington
country: United States
facility: Duramed Investigational Site
state: Delaware
city: Washington
country: United States
facility: Duramed Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Duramed Investigational Site
state: Florida
city: Boynton Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: Brooksville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Duramed Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: Duramed Investigational Site
state: Florida
city: Fort Meyers
country: United States
facility: Duramed Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Duramed Investigational Site
state: Florida
city: Longwood
country: United States
facility: Duramed Investigational Site
state: Florida
city: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Duramed Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Duramed Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Duramed Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Duramed Investigational Site
state: Florida
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Boise
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Shawnee Mission
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Topeka
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Mt Sterling
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Kansas City
country: United States
facility: Duramed Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Duramed Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Moorestown
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Duramed Investigational Site
state: New Mexico
city: Johnson City
country: United States
facility: Duramed Investigational Site
state: New York
city: Rochester
country: United States
facility: Duramed Investigational Site
state: New York
city: Charlotte
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Duramed Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Cranston
country: United States
facility: Duramed Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Mt Pleasant
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Clarksville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Duramed Investigational Site
state: Texas
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Waco
country: United States
facility: Duramed Investigational Site
state: Texas
city: Magna
country: United States
facility: Duramed Investigational Site
state: Utah
city: Pleasant Grove
country: United States
facility: Duramed Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
city: Sandy
country: United States
facility: Duramed Investigational Site
state: Utah
city: Arlington
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Newport News
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Lakewood
country: United States
facility: Duramed Investigational Site
state: Washington
city: Seattle
country: United States
facility: Duramed Investigational Site
state: Washington
city: Spokane
country: United States
facility: Duramed Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Duramed Investigational Site
state: Washington
Study officials:
affiliation: Duramed Research
name: Duramed Medical Monitor
role: PRINCIPAL_INVESTIGATOR
References: