Clinical trial NCT00477633: Study of Safety and Efficacy of an Oral Contraceptive
Official title: An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraception
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 1700
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 a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.


Eligibility criteria: Inclusion Criteria:

* Healthy Women
* Age 18-45
* At risk for pregnancy
* History of regular cycles

Exclusion Criteria:

* Contraindications for use of hormonal contraception
* Conditions which affect the absorption or metabolism of steroid hormones
* BMI\>35

Primary outcomes:
measure: Pearl Index, 18-35 Years, MITT Population
timeFrame: 13 cycles (28 days each), approximately 364 days
Secondary outcomes:
measure: Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
timeFrame: 12 cycles (28 days each), approximately 336 days
measure: Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
timeFrame: 12 cycles (28 days each), approximately 336 days
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Vista
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Castle Rock
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Denver
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Boynton Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Brooksville
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Decatur
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Champaign
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: Arkansas City
country: United States
facility: Warner Chilcott Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Warner Chilcott Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Amite
country: United States
facility: Warner Chilcott Investigational Site
state: Louisiana
city: Marrero
country: United States
facility: Warner Chilcott Investigational Site
state: Louisiana
city: Chaska
country: United States
facility: Warner Chilcott Investigational Site
state: Minnesota
city: Berlin
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Edison
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Moorestown
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: New York
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Cary
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Warner Chilcott Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Warner Chilcott Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Pottstown
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Austin
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Dallas
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Houston
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Magna
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: West Valley City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
Study officials:
affiliation: Sponsor GmbH
name: Herman Ellman
role: STUDY_DIRECTOR
References: