Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception

Contraceptive Usage Clinical Trial

— Simplify  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140217
• Other study ID #: NE0906
• 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

• Contraceptive Usage

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