Clinical trial NCT01140217: Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception
Official title: An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraceptive Usage
Keywords: contraception
pregnancy
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-06-09
Enrollment: 1659
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.

Detailed description: An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.

Eligibility criteria: Inclusion Criteria:

* Healthy females
* 18-45 years
* Regular, consistent menstrual cycles between 25 and 35 days
* Sexually active and at risk of becoming pregnant

Exclusion Criteria:

* History of infertility
* Known contraindications to progestogen administration
* Pap smear suggestive of a high-grade precancerous lesion(s)
* Clinically significant deviation from normal in any of the screening tests or exams

Primary outcomes:
measure: Pregnancy Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Watson Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Watson Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Watson Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Watson Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Watson Investigational Site
state: Arkansas
city: Garden Grove
country: United States
facility: Watson Investigational Site
state: California
city: La Mesa
country: United States
facility: Watson Investigational Site
state: California
city: San Diego
country: United States
facility: Watson Investigational Site
state: California
city: Denver
country: United States
facility: Watson Investigational Site
state: Colorado
city: Newark
country: United States
facility: Watson Investigational Site
state: Delaware
city: Washington
country: United States
facility: Watson Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Watson Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Watson Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Watson Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Watson Investigational Site
state: Florida
city: Miami
country: United States
facility: Watson Investigational Site
state: Florida
city: North Miami
country: United States
facility: Watson Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Watson Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Watson Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Watson Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Watson Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Watson Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Watson Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Watson Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Watson Investigational Site
state: Kansas
city: Marrero
country: United States
facility: Watson Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Watson Investigational Site
state: Louisiana
city: Haverhill
country: United States
facility: Watson Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Watson Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Watson Investigational Site
state: Michigan
city: Edina
country: United States
facility: Watson Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: Watson Investigational Site
state: Nevada
city: Lawrenceville
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Watson Investigational Site
state: New Mexico
city: New York
country: United States
facility: Watson Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Watson Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: Watson Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Watson Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Watson Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Watson Investigational Site
state: Ohio
city: Medford
country: United States
facility: Watson Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Watson Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Watson Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Watson Investigational Site
state: South Carolina
city: Hilton Head Island
country: United States
facility: Watson Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Watson Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Watson Investigational Site
state: Texas
city: Dallas
country: United States
facility: Watson Investigational Site
state: Texas
city: Houston
country: United States
facility: Watson Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Watson Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Watson Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Watson Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Watson Investigational Site
state: Washington
Study officials:
affiliation: Watson Pharmaceuticals, Inc.
name: Kim E Caramelli, MS
role: STUDY_DIRECTOR
References: