Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception
NCT ID: NCT01140217
Last Updated: 2013-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1659 participants
INTERVENTIONAL
2010-05-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Active treatment
Norethindrone Acetate Transdermal Delivery System
Norethindrone Acetate
Norethindrone Acetate Transdermal Delivery System
Interventions
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Norethindrone Acetate
Norethindrone Acetate Transdermal Delivery System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-45 years
* Regular, consistent menstrual cycles between 25 and 35 days
* Sexually active and at risk of becoming pregnant
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Kim E Caramelli, MS
Role: STUDY_DIRECTOR
Watson Pharmaceuticals, Inc.
Locations
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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 D.C., 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
Countries
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Other Identifiers
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NE0906
Identifier Type: -
Identifier Source: org_study_id