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

Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraceptive Usage

Intervention: Norethindrone Acetate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Watson Pharmaceuticals

Official(s) and/or principal investigator(s):
Kim E Caramelli, MS, Study Director, Affiliation: Watson Pharmaceuticals, Inc.

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.

Clinical Details

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

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

Primary outcome: Pregnancy Rate

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

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Watson Investigational Site, Birmingham, Alabama, United States

Watson Investigational Site, Mobile, Alabama, United States

Watson Investigational Site, Montgomery, Alabama, United States

Watson Investigational Site, Chandler, Arizona, United States

Watson Investigational Site, Little Rock, Arkansas, United States

Watson Investigational Site, Garden Grove, California, United States

Watson Investigational Site, La Mesa, California, United States

Watson Investigational Site, San Diego, California, United States

Watson Investigational Site, Denver, Colorado, United States

Watson Investigational Site, Newark, Delaware, United States

Watson Investigational Site, Washington, District of Columbia, United States

Watson Investigational Site, 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, 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, Chicago, Illinois, United States

Watson Investigational Site, Overland Park, Kansas, United States

Watson Investigational Site, Marrero, Louisiana, United States

Watson Investigational Site, New Orleans, Louisiana, United States

Watson Investigational Site, Haverhill, Massachusetts, United States

Watson Investigational Site, Ann Arbor, Michigan, United States

Watson Investigational Site, Kalamazoo, Michigan, United States

Watson Investigational Site, Edina, Minnesota, United States

Watson Investigational Site, Las Vegas, Nevada, United States

Watson Investigational Site, Lawrenceville, New Jersey, United States

Watson Investigational Site, Albuquerque, New Mexico, United States

Watson Investigational Site, New York, New York, United States

Watson Investigational Site, 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, Cleveland, Ohio, United States

Watson Investigational Site, Columbus, Ohio, United States

Watson Investigational Site, Medford, Oregon, United States

Watson Investigational Site, Philadelphia, Pennsylvania, United States

Watson Investigational Site, 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, Nashville, Tennessee, United States

Watson Investigational Site, 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, Salt Lake City, Utah, United States

Watson Investigational Site, Norfolk, Virginia, United States

Watson Investigational Site, Seattle, Washington, United States

Additional Information

Starting date: May 2010
Last updated: September 13, 2013

Page last updated: August 23, 2015

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