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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01140217
Other study ID # NE0906
Secondary ID
Status Completed
Phase Phase 3
First received May 18, 2010
Last updated September 13, 2013
Start date May 2010
Est. completion date March 2012

Study information

Verified date September 2013
Source Watson Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 1659
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Norethindrone Acetate
Norethindrone Acetate Transdermal Delivery System

Locations

Country Name City State
United States Watson Investigational Site Albuquerque New Mexico
United States Watson Investigational Site Ann Arbor Michigan
United States Watson Investigational Site Atlanta Georgia
United States Watson Investigational Site Austin Texas
United States Watson Investigational Site Aventura Florida
United States Watson Investigational Site Birmingham Alabama
United States Watson Investigational Site Chandler Arizona
United States Watson Investigational Site Chapel Hill North Carolina
United States Watson Investigational Site Chicago Illinois
United States Watson Investigational Site Cleveland Ohio
United States Watson Investigational Site Columbia South Carolina
United States Watson Investigational Site Columbus Ohio
United States Watson Investigational Site Dallas Texas
United States Watson Investigational Site Daytona Beach Florida
United States Watson Investigational Site Decatur Georgia
United States Watson Investigational Site Denver Colorado
United States Watson Investigational Site Edina Minnesota
United States Watson Investigational Site Garden Grove California
United States Watson Investigational Site Greer South Carolina
United States Watson Investigational Site Haverhill Massachusetts
United States Watson Investigational Site Hilton Head Island South Carolina
United States Watson Investigational Site Houston Texas
United States Watson Investigational Site Jacksonville Florida
United States Watson Investigational Site Kalamazoo Michigan
United States Watson Investigational Site La Mesa California
United States Watson Investigational Site Lake Worth Florida
United States Watson Investigational Site Las Vegas Nevada
United States Watson Investigational Site Lawrenceville New Jersey
United States Watson Investigational Site Little Rock Arkansas
United States Watson Investigational Site Marrero Louisiana
United States Watson Investigational Site Medford Oregon
United States Watson Investigational Site Miami Florida
United States Watson Investigational Site Mobile Alabama
United States Watson Investigational Site Montgomery Alabama
United States Watson Investigational Site Nashville Tennessee
United States Watson Investigational Site New Bern North Carolina
United States Watson Investigational Site New Orleans Louisiana
United States Watson Investigational Site New York New York
United States Watson Investigational Site Newark Delaware
United States Watson Investigational Site Norfolk Virginia
United States Watson Investigational Site North Miami Florida
United States Watson Investigational Site Overland Park Kansas
United States Watson Investigational Site Philadelphia Pennsylvania
United States Watson Investigational Site Pinellas Park Florida
United States Watson Investigational Site Raleigh North Carolina
United States Watson Investigational Site Salt Lake City Utah
United States Watson Investigational Site San Antonio Texas
United States Watson Investigational Site San Diego California
United States Watson Investigational Site Sandy Springs Georgia
United States Watson Investigational Site Sarasota Florida
United States Watson Investigational Site Savannah Georgia
United States Watson Investigational Site Seattle Washington
United States Watson Investigational Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy Rate The pregnancy rate will be calculated using the Pearl Index that defined as 1300*Number of pregnancies/Number of cycles of treatment. 1 year No
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