Clinical trial NCT00196326: Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Official title: A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle
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: 2005-09-20
Enrollment: 2235
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 one year of oral contraceptive therapy with DR-1011. 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:

* 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: Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
timeFrame: up to one year
measure: Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
timeFrame: up to one year
Secondary outcomes:
measure: Participants With Treatment-Emergent Adverse Events
timeFrame: Day 1 up to one year
Other outcomes:
Locations:
city: Huntsville
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: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
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: Colorado Springs
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Denver
country: United States
facility: Duramed Investigational Site
state: Colorado
city: New London
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Coral Cables
country: United States
facility: Duramed Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Duramed Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Duramed Investigational Site
state: Florida
city: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: Palm Springs
country: United States
facility: Duramed Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Duramed Investigational Site
state: Florida
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: Decatur
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Douglasville
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: Shawnee Mission
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Topeka
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Kansas City
country: United States
facility: Duramed Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Duramed Investigational Site
state: Missouri
city: Lawrenceville
country: United States
facility: Duramed Investigational Site
state: New Jersey
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: Rochester
country: United States
facility: Duramed Investigational Site
state: New York
city: Charlotte
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
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: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
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: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
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, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References:
citation: Kroll R, Reape KZ, Margolis M. The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol. Contraception. 2010 Jan;81(1):41-8. doi: 10.1016/j.contraception.2009.07.003.