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

September 13, 2013 updated by: Watson Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1659

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active treatment
Norethindrone Acetate Transdermal Delivery System
Drug: Norethindrone Acetate
Norethindrone Acetate Transdermal Delivery System
Other Names:
  • NEA TDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate
Time Frame: 1 year
The pregnancy rate will be calculated using the Pearl Index that defined as 1300*Number of pregnancies/Number of cycles of treatment.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Kim E Caramelli, MS, Watson Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 13, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE0906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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