Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

NCT00362479 | Completed Phase 3

• 1 other identifier: DR-DSG-301
• Study Type: interventional
• Target: 1,347
• Locations: 1 country
• Sites: 85

Brief Summary

This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Conditions

Contraception

Keywords

pregnancy prevention; oral contraceptives

Outcome Measures

Primary Outcomes (1)

• Evaluation of pregnancy rates

  Duration of study

Secondary Outcomes (1)

• Adverse events reported by patients and investigators

  Duration of study

Study Arms (1)

1

EXPERIMENTAL

Drug: DR-1021

Interventions

DR-1021 DRUG

1 tablet daily

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal
• Not pregnant or breastfeeding
• Sexually active at risk of pregnancy

You may not qualify if:

• Any contraindication to the use of oral contraceptives
• Pregnancy within the last 3 months
• Smoking \> 10 cigarettes per day

Sponsors & Collaborators

• Duramed Research: lead

Study Sites (85)

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85015, United States

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Phoenix, Arizona, 85031, United States

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Carmichael, California, 95608, United States

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Irvine, California, 92618, United States

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San Diego, California, 92108, United States

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San Diego, California, 92123, United States

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San Ramon, California, 94583, United States

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Colorado Springs, Colorado, 80909, United States

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Lakewood, Colorado, 80228, United States

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Wilmington, Delaware, 19805, United States

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Washington D.C., District of Columbia, 20006, United States

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Aventura, Florida, 33180, United States

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Boynton Beach, Florida, 33437, United States

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Brooksville, Florida, 33613, United States

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Clearwater, Florida, 33761, United States

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Coral Gables, Florida, 33134, United States

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Fort Meyers, Florida, 33918, United States

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Leesburg, Florida, 34748, United States

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Longwood, Florida, 32779, United States

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Miami, Florida, 33173, United States

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Pinellas Park, Florida, 33781, United States

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Sarasota, Florida, 34239, United States

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St. Petersburg, Florida, 33702, United States

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St. Petersburg, Florida, 33709, United States

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Tampa, Florida, 33613, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30034, United States

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Roswell, Georgia, 30075, United States

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Boise, Idaho, 83704, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Peoria, Illinois, 61602, United States

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Shawnee Mission, Kansas, 66216, United States

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Topeka, Kansas, 66614, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40291, United States

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Mount Sterling, Kentucky, 40353, United States

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Kansas City, Missouri, 64108, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89146, United States

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Moorestown, New Jersey, 08057, United States

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New Brunswick, New Jersey, 08901, United States

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Albuquerque, New Mexico, 87102, United States

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Johnson City, New York, 13790, United States

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Rochester, New York, 14609, United States

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Charlotte, North Carolina, 28211, United States

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Raleigh, North Carolina, 27612, United States

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Wilmington, North Carolina, 28412, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73112, United States

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Medford, Oregon, 97504, United States

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Philadelphia, Pennsylvania, 19114, United States

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Reading, Pennsylvania, 19606, United States

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Cranston, Rhode Island, 02920, United States

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Greer, South Carolina, 29651, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Bristol, Tennessee, 37620, United States

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Chattanooga, Tennessee, 37404, United States

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Clarksville, Tennessee, 37043, United States

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Germantown, Tennessee, 38138, United States

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Knoxville, Tennessee, 37920, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78759, United States

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Dallas, Texas, 75234, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Waco, Texas, 76712, United States

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Magna, Utah, 84044, United States

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Pleasant Grove, Utah, 84062, United States

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Salt Lake City, Utah, 84124, United States

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Sandy City, Utah, 84070, United States

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Arlington, Virginia, 22203, United States

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Newport News, Virginia, 23602, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23233, United States

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Lakewood, Washington, 98499, United States

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Seattle, Washington, 98105, United States

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Spokane, Washington, 99207, United States

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Tacoma, Washington, 98405, United States

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Study Officials

• Duramed Medical Monitor

  Duramed Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 10, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

US (85)