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

NCT ID: NCT00362479

Last Updated: 2013-08-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Contraception

Keywords

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pregnancy prevention oral contraceptives

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

DR-1021

Intervention Type DRUG

1 tablet daily

Interventions

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DR-1021

1 tablet daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Duramed Research, Inc.

Principal Investigators

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Duramed Medical Monitor

Role: PRINCIPAL_INVESTIGATOR

Duramed Research

Locations

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Carmichael, California, United States

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Irvine, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Colorado Springs, Colorado, United States

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Lakewood, Colorado, United States

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Wilmington, Delaware, United States

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

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Aventura, Florida, United States

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Boynton Beach, Florida, United States

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Brooksville, Florida, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Fort Meyers, Florida, United States

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Leesburg, Florida, United States

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Longwood, Florida, United States

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Miami, Florida, United States

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Pinellas Park, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Roswell, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Shawnee Mission, Kansas, United States

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Topeka, 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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Kansas City, Missouri, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, 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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Johnson City, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Clarksville, Tennessee, United States

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Germantown, Tennessee, United States

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Knoxville, 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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Houston, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Magna, Utah, United States

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Pleasant Grove, Utah, United States

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Salt Lake City, Utah, United States

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Sandy City, Utah, United States

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Arlington, Virginia, United States

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Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Lakewood, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Countries

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United States

Other Identifiers

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DR-DSG-301

Identifier Type: -

Identifier Source: org_study_id