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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00362479
First received: August 9, 2006
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Contraception
Drug: DR-1021
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Evaluation of pregnancy rates [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events reported by patients and investigators [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 1347
Study Start Date: August 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-1021
1 tablet daily

Detailed Description:

The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any contraindication to the use of oral contraceptives
  • Pregnancy within the last 3 months
  • Smoking > 10 cigarettes per day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362479

  Hide Study Locations
Locations
United States, Alabama
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
Duramed Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Duramed Investigational Site
Phoenix, Arizona, United States, 85031
Duramed Investigational Site
Phoenix, Arizona, United States, 85015
United States, California
Duramed Investigational Site
Carmichael, California, United States, 95608
Duramed Investigational Site
Irvine, California, United States, 92618
Duramed Investigational Site
San Diego, California, United States, 92108
Duramed Investigational Site
San Diego, California, United States, 92123
Duramed Investigational Site
San Ramon, California, United States, 94583
United States, Colorado
Duramed Investigational Site
Colorado Springs, Colorado, United States, 80909
Duramed Investigational Site
Lakewood, Colorado, United States, 80228
United States, Delaware
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Wilmington, Delaware, United States, 19805
United States, District of Columbia
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Washington, District of Columbia, United States, 20006
United States, Florida
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Aventura, Florida, United States, 33180
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Boynton Beach, Florida, United States, 33437
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Brooksville, Florida, United States, 33613
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Clearwater, Florida, United States, 33761
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Coral Gables, Florida, United States, 33134
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Fort Meyers, Florida, United States, 33918
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Leesburg, Florida, United States, 34748
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Longwood, Florida, United States, 32779
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Miami, Florida, United States, 33173
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Pinellas Park, Florida, United States, 33781
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Sarasota, Florida, United States, 34239
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St. Petersburg, Florida, United States, 33709
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St. Petersburg, Florida, United States, 33702
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Tampa, Florida, United States, 33613
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West Palm Beach, Florida, United States, 33409
United States, Georgia
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Atlanta, Georgia, United States, 30328
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Atlanta, Georgia, United States, 30342
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Decatur, Georgia, United States, 30034
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Roswell, Georgia, United States, 30075
United States, Idaho
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Boise, Idaho, United States, 83704
United States, Illinois
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Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60611
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Peoria, Illinois, United States, 61602
United States, Kansas
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Shawnee Mission, Kansas, United States, 66216
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Topeka, Kansas, United States, 66614
United States, Kentucky
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Lexington, Kentucky, United States, 40509
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Louisville, Kentucky, United States, 40291
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Mt Sterling, Kentucky, United States, 40353
United States, Missouri
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Kansas City, Missouri, United States, 64108
United States, Nebraska
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Lincoln, Nebraska, United States, 68510
United States, Nevada
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Las Vegas, Nevada, United States, 89146
United States, New Jersey
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Moorestown, New Jersey, United States, 08057
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New Brunswick, New Jersey, United States, 08901
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
United States, New York
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Johnson City, New York, United States, 13790
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Rochester, New York, United States, 14609
United States, North Carolina
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Charlotte, North Carolina, United States, 28211
Duramed Investigational Site
Raleigh, North Carolina, United States, 27612
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Wilmington, North Carolina, United States, 28412
Duramed Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Columbus, Ohio, United States, 43210
Duramed Investigational Site
Columbus, Ohio, United States, 43213
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Duramed Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19114
Duramed Investigational Site
Reading, Pennsylvania, United States, 19606
United States, Rhode Island
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Cranston, Rhode Island, United States, 02920
United States, South Carolina
Duramed Investigational Site
Greer, South Carolina, United States, 29651
Duramed Investigational Site
Mt Pleasant, South Carolina, United States, 29464
United States, Tennessee
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Bristol, Tennessee, United States, 37620
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Chattanooga, Tennessee, United States, 37404
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Clarksville, Tennessee, United States, 37043
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Germantown, Tennessee, United States, 38138
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Knoxville, Tennessee, United States, 37920
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Nashville, Tennessee, United States, 37203
United States, Texas
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Austin, Texas, United States, 78759
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Dallas, Texas, United States, 75234
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Houston, Texas, United States, 77030
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San Antonio, Texas, United States, 78229
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Waco, Texas, United States, 76712
United States, Utah
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Magna, Utah, United States, 84044
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Pleasant Grove, Utah, United States, 84062
Duramed Investigational Site
Salt Lake City, Utah, United States, 84124
Duramed Investigational Site
Sandy, Utah, United States, 84070
United States, Virginia
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Arlington, Virginia, United States, 22203
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Newport News, Virginia, United States, 23602
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Norfolk, Virginia, United States, 23507
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Richmond, Virginia, United States, 23233
United States, Washington
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Lakewood, Washington, United States, 98499
Duramed Investigational Site
Seattle, Washington, United States, 98105
Duramed Investigational Site
Spokane, Washington, United States, 99207
Duramed Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Duramed Research
Investigators
Principal Investigator: Duramed Medical Monitor Duramed Research
  More Information

No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00362479     History of Changes
Other Study ID Numbers: DR-DSG-301
Study First Received: August 9, 2006
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
pregnancy prevention
oral contraceptives

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on July 26, 2014