A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
NCT ID: NCT00996580
Last Updated: 2013-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3597 participants
INTERVENTIONAL
2009-10-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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DR-103
Four 91-day cycles of the DR-103 regimen:
* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
DR-103
One tablet daily.
Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.
Interventions
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DR-103
One tablet daily.
Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Agreement to use study OC therapy as their only method of birth control during the study
* history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
* Others as dictated by FDA-approved protocol
Exclusion Criteria
* Pregnancy or plans to become pregnant in the next 14 months
* Smoker and age ≥ 35 years
* Others as dictated by FDA-approved protocol
18 Years
40 Years
FEMALE
Yes
Sponsors
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Teva Women's Health
INDUSTRY
Responsible Party
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Locations
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Teva Women's Health Research Investigational Site
Montgomery, Alabama, United States
Teva Women's Health Research Investigational Site
Phoenix, Arizona, United States
Teva Women's Health Research Investigational Site
Phoenix, Arizona, United States
Teva Women's Health Research Investigational Site
Tucson, Arizona, United States
Teva Women's Health Research Investigational Site
Little Rock, Arkansas, United States
Teva Women's Health Research Investigational Site
Anaheim, California, United States
Teva Women's Health Research Investigational Site
Irvine, California, United States
Teva Women's Health Research Investigational Site
Los Angeles, California, United States
Teva Women's Health Research Investigational Site
National City, California, United States
Teva Women's Health Research Investigational Site
San Diego, California, United States
Teva Women's Health Research Investigational Site
San Diego, California, United States
Teva Women's Health Research Investigational Site
San Diego, California, United States
Teva Women's Health Research Investigational Site
San Francisco, California, United States
Teva Women's Health Research Investigational Site
Torrance, California, United States
Teva Women's Health Research Investigational Site
Colorado Springs, Colorado, United States
Teva Women's Health Research Investigational Site
Pueblo, Colorado, United States
Teva Women's Health Research Investigational Site
Washington D.C., District of Columbia, United States
Teva Women's Health Research Investigational Site
Clearwater, Florida, United States
Teva Women's Health Research Investigational Site
Jacksonville, Florida, United States
Teva Women's Health Research Investigational Site
Leesburg, Florida, United States
Teva Women's Health Research Investigational Site
Miami, Florida, United States
Teva Women's Health Research Investigational Site
Miami, Florida, United States
Teva Women's Health Research Investigational Site
New Port Richey, Florida, United States
Teva Women's Health Research Investigational Site
Palm Beach, Florida, United States
Teva Women's Health Research Investigational Site
St. Petersburg, Florida, United States
Teva Women's Health Research Investigational Site
Tampa, Florida, United States
Teva Women's Health Research Investigational Site
West Palm Beach, Florida, United States
Teva Women's Health Research Investigational Site
Atlanta, Georgia, United States
Teva Women's Health Research Investigational Site
Decatur, Georgia, United States
Teva Women's Health Research Investigational Site
Roswell, Georgia, United States
Teva Women's Health Research Investigational Site
Sandy Springs, Georgia, United States
Teva Women's Health Research Investigational Site
Savannah, Georgia, United States
Teva Women's Health Research Investigational Site
Meridian, Idaho, United States
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Champaign, Illinois, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Lawrenceville, New Jersey, United States
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Moorestown, New Jersey, United States
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New Brunswick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Port Jefferson, New York, United States
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Rochester, New York, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
Teva Women's Health Research Investigational Site
Winston-Salem, North Carolina, United States
Teva Women's Health Research Investigational Site
Columbus, Ohio, United States
Teva Women's Health Research Investigational Site
Columbus, Ohio, United States
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Edmond, Oklahoma, United States
Teva Women's Health Research Investigational Site
Oklahoma City, Oklahoma, United States
Teva Women's Health Research Investigational Site
Eugene, Oregon, United States
Teva Women's Health Research Investigational Site
Medford, Oregon, United States
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Philadelphia, Pennsylvania, United States
Teva Women's Health Research Investigational Site
Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Goose Creek, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Hilton Head Island, South Carolina, United States
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Bristol, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
Teva Women's Health Research Investigational Site
Waco, Texas, United States
Teva Women's Health Research Investigational Site
Salt Lake City, Utah, United States
Teva Women's Health Research Investigational Site
Arlington, Virginia, United States
Teva Women's Health Research Investigational Site
Newport News, Virginia, United States
Teva Women's Health Research Investigational Site
Norfolk, Virginia, United States
Teva Women's Health Research Investigational Site
Norfolk, Virginia, United States
Teva Women's Health Research Investigational Site
Richmond, Virginia, United States
Teva Women's Health Research Investigational Site
Seattle, Washington, United States
Teva Women's Health Research Investigational Site
Tacoma, Washington, United States
Countries
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References
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Poindexter A, Reape KZ, Hait H. Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo. Contraception. 2008 Aug;78(2):113-9. doi: 10.1016/j.contraception.2008.04.001. Epub 2008 Jun 2.
Portman DJ, Kaunitz AM, Howard B, Weiss H, Hsieh J, Ricciotti N. Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive. Contraception. 2014 Apr;89(4):299-306. doi: 10.1016/j.contraception.2014.01.013. Epub 2014 Jan 29.
Other Identifiers
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DR-103-301
Identifier Type: -
Identifier Source: org_study_id
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