Clinical trial NCT00932321: Study of Safety and Efficacy of an Oral Contraceptive
Official title: Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of Pregnancy
Keywords: Contraception
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 938
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 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 of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; 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: Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population
timeFrame: 5.6 months (6 - 28 day cycles)
Secondary outcomes:
measure: Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population
timeFrame: 5.6 months (6 - 28 day cycles)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
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: Chico
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Los Angeles
country: United States
facility: Warner Chilcott Investigational Site
state: California
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: Denver
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Boynton Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Venice
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: Decatur
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Powder Springs
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Louisville
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Kansas City
country: United States
facility: Warner Chilcott Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Warner Chilcott Investigational Site
state: Missouri
city: New Bern
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: Allentown
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
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: Charleston
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Sandy
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
city: Seattle
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Sponsor GmbH
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: