A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
NCT ID: NCT00196365
Last Updated: 2014-05-12
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
97 participants
INTERVENTIONAL
2005-01-31
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
1 tablet daily
2
levonorgestrel/EE 0.15/0.03 mg tablets and placebo
1 tablet daily
Interventions
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levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
1 tablet daily
levonorgestrel/EE 0.15/0.03 mg tablets and placebo
1 tablet daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular spontaneous menstrual cycles
Exclusion Criteria
* Treatment with an oral contraceptive in the last 3 months
* Previous treatment failure with an extended oral contraceptive regimen
18 Years
40 Years
FEMALE
No
Sponsors
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Duramed Research
INDUSTRY
Responsible Party
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Duramed Research, Inc.
Principal Investigators
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Duramed Protocol Chair
Role: STUDY_CHAIR
Duramed Research, Inc.
Locations
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Duramed Investigational Site
Huntsville, Alabama, United States
Duramed Investigational Site
Phoenix, Arizona, United States
Duramed Investigational Site
San Diego, California, United States
Duramed Investigational Site
Denver, Colorado, United States
Duramed Investigational Site
Tampa, Florida, United States
Duramed Investigational Site
Decatur, Georgia, United States
Duramed Investigational Site
Moorestown, New Jersey, United States
Duramed Investigational Site
Charlotte, North Carolina, United States
Duramed Investigational Site
Columbus, Ohio, United States
Duramed Investigational Site
Columbus, Ohio, United States
Duramed Investigational Site
Medford, Oregon, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, United States
Duramed Investigational Site
Memphis, Tennessee, United States
Duramed Investigational Site
Salt Lake City, Utah, United States
Duramed Investigational Site
Newport News, Virginia, United States
Duramed Investigational Site
Norfolk, Virginia, United States
Duramed Investigational Site
Spokane, Washington, United States
Duramed Investigational Site
Tacoma, Washington, United States
Countries
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Other Identifiers
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DR-PSE-305
Identifier Type: -
Identifier Source: org_study_id
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