Clinical trial NCT00996580: A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy Prevention
Keywords: Contraception
Oral contraceptives
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 3597
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.


Eligibility criteria: Inclusion Criteria:

* Sexually active at risk for pregnancy
* Agreement to use study OC therapy as their only method of birth control during the study
* history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
* Others as dictated by FDA-approved protocol

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy or plans to become pregnant in the next 14 months
* Smoker and age ≥ 35 years
* Others as dictated by FDA-approved protocol

Primary outcomes:
measure: All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: Day 1 up to year 1
measure: Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: Day 1 up to year 1
measure: Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: Day 1 up to year 1
measure: All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: Day 1 up to year 1
measure: Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: Day 1 up to year 1
measure: Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: Day 1 up to year 1
measure: Summary of Participants With Treatment-emergent Adverse Events
timeFrame: Day 1 up to 13 months
Secondary outcomes:
measure: All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: Day 1 up to year 1
measure: Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight
timeFrame: Day 1 up to year 1
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Teva Women's Health Research Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Teva Women's Health Research Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Teva Women's Health Research Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Teva Women's Health Research Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Teva Women's Health Research Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: Irvine
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: Los Angeles
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: National City
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: San Diego
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: San Diego
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: San Diego
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: San Francisco
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: Torrance
country: United States
facility: Teva Women's Health Research Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Teva Women's Health Research Investigational Site
state: Colorado
city: Pueblo
country: United States
facility: Teva Women's Health Research Investigational Site
state: Colorado
city: Washington
country: United States
facility: Teva Women's Health Research Investigational Site
state: District of Columbia
city: Clearwater
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: Miami
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: Miami
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: Palm Beach
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: Tampa
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Teva Women's Health Research Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Teva Women's Health Research Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Teva Women's Health Research Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Teva Women's Health Research Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Teva Women's Health Research Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Teva Women's Health Research Investigational Site
state: Georgia
city: Meridian
country: United States
facility: Teva Women's Health Research Investigational Site
state: Idaho
city: Champaign
country: United States
facility: Teva Women's Health Research Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Teva Women's Health Research Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Teva Women's Health Research Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Teva Women's Health Research Investigational Site
state: Kentucky
city: Mt Sterling
country: United States
facility: Teva Women's Health Research Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Teva Women's Health Research Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Teva Women's Health Research Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Teva Women's Health Research Investigational Site
state: Maryland
city: Kansas City
country: United States
facility: Teva Women's Health Research Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Teva Women's Health Research Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Teva Women's Health Research Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Teva Women's Health Research Investigational Site
state: Nevada
city: Berlin
country: United States
facility: Teva Women's Health Research Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Teva Women's Health Research Investigational Site
state: New Jersey
city: Moorestown
country: United States
facility: Teva Women's Health Research Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Teva Women's Health Research Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Teva Women's Health Research Investigational Site
state: New Mexico
city: Port Jefferson
country: United States
facility: Teva Women's Health Research Investigational Site
state: New York
city: Rochester
country: United States
facility: Teva Women's Health Research Investigational Site
state: New York
city: Cary
country: United States
facility: Teva Women's Health Research Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Teva Women's Health Research Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: Teva Women's Health Research Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Teva Women's Health Research Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Teva Women's Health Research Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Teva Women's Health Research Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Teva Women's Health Research Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Women's Health Research Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Teva Women's Health Research Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Teva Women's Health Research Investigational Site
state: Ohio
city: Edmond
country: United States
facility: Teva Women's Health Research Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Women's Health Research Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Teva Women's Health Research Investigational Site
state: Oregon
city: Medford
country: United States
facility: Teva Women's Health Research Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Teva Women's Health Research Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Women's Health Research Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Teva Women's Health Research Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Teva Women's Health Research Investigational Site
state: South Carolina
city: Goose Creek
country: United States
facility: Teva Women's Health Research Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Teva Women's Health Research Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Teva Women's Health Research Investigational Site
state: South Carolina
city: Hilton Head Island
country: United States
facility: Teva Women's Health Research Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Teva Women's Health Research Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: Teva Women's Health Research Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Teva Women's Health Research Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Teva Women's Health Research Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Teva Women's Health Research Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Teva Women's Health Research Investigational Site
state: Texas
city: Dallas
country: United States
facility: Teva Women's Health Research Investigational Site
state: Texas
city: Dallas
country: United States
facility: Teva Women's Health Research Investigational Site
state: Texas
city: Ft. Worth
country: United States
facility: Teva Women's Health Research Investigational Site
state: Texas
city: Houston
country: United States
facility: Teva Women's Health Research Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Teva Women's Health Research Investigational Site
state: Texas
city: Waco
country: United States
facility: Teva Women's Health Research Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Teva Women's Health Research Investigational Site
state: Utah
city: Arlington
country: United States
facility: Teva Women's Health Research Investigational Site
state: Virginia
city: Newport News
country: United States
facility: Teva Women's Health Research Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Teva Women's Health Research Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Teva Women's Health Research Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Teva Women's Health Research Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Teva Women's Health Research Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Teva Women's Health Research Investigational Site
state: Washington
Study officials:
References:
citation: Poindexter A, Reape KZ, Hait H. Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo. Contraception. 2008 Aug;78(2):113-9. doi: 10.1016/j.contraception.2008.04.001. Epub 2008 Jun 2.
citation: Portman DJ, Kaunitz AM, Howard B, Weiss H, Hsieh J, Ricciotti N. Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive. Contraception. 2014 Apr;89(4):299-306. doi: 10.1016/j.contraception.2014.01.013. Epub 2014 Jan 29.