A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale. - Full Text View

Sponsor:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00394771

Purpose

This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. 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
Breakthrough Bleeding	Drug: DR-1031a Drug: DR-1031b Drug: DR-1031c Drug: Seasonale	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen

Further study details as provided by Duramed Research:

Primary Outcome Measures:

Total number of bleeding and/or spotting days during active treatment period. [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total number of bleeding days during active treatment period [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
Timing and severity of bleeding [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
Onset,duration,severity of scheduled withdrawal bleeding [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
Number of subjects reporting hormone-related symptoms [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
Adverse events reported by subjects and investigators [ Time Frame: Active treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	October 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: DR-1031a 1 tablet daily
2: Experimental	Drug: DR-1031b 1 tablet daily
3: Experimental	Drug: DR-1031c 1 tablet daily
4: Active Comparator	Drug: Seasonale 1 tablet daily

Detailed Description:

This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days 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
Agree to use back-up non-hormonal contraception for study period

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394771

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Locations

United States, Alabama
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Duramed Investigational Site
Tucson, Arizona, United States, 85741
United States, Arkansas
Duramed Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Duramed Investigational Site
San Diego, California, United States, 92108
Duramed Investigational Site
San Francisco, California, United States, 94102
Duramed Investigational Site
Vista, California, United States, 92083
Duramed Investigational Site
Santa Ana, California, United States, 92705
United States, Colorado
Duramed Investigational Site
Pueblo, Colorado, United States, 81001
United States, Connecticut
Duramed Investigational Site
Stratford, Connecticut, United States, 06615
United States, Florida
Duramed Investigational Site
West Palm Beach, Florida, United States, 33401
Duramed Investigational Site
Miami, Florida, United States, 33186
Duramed Investigational Site
Deland, Florida, United States, 32720
Duramed Investigational Site
Jacksonville, Florida, United States, 32207
Duramed Investigational Site
Melbourne, Florida, United States, 32935
Duramed Investigational Site
West Palm Beach, Florida, United States, 33407
Duramed Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Duramed Investigational Site
Alpharetta, Georgia, United States, 30005
Duramed Investigational Site
Savannah, Georgia, United States, 31406
Duramed Investigational Site
Douglasville, Georgia, United States, 30134
United States, Idaho
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Meridian, Idaho, United States, 83642
Duramed Investigational Site
Boise, Idaho, United States, 83712
United States, Indiana
Duramed Investigational Site
Fort Wayne, Indiana, United States, 46825
United States, Kansas
Duramed Investigational Site
Wichita, Kansas, United States, 67205
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
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Shreveport, Louisiana, United States, 71106
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Metairie, Louisiana, United States, 70006
United States, Maryland
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Riverdale, Maryland, United States, 20737
United States, Missouri
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Kansas City, Missouri, United States, 64114
United States, Nevada
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Las Vegas, Nevada, United States, 89128
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N. Las Vegas, Nevada, United States, 89030
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Las Vegas, Nevada, United States, 89109
United States, New Hampshire
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Lebanon, New Hampshire, United States, 03756
United States, North Carolina
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Winston-Salem, North Carolina, United States, 27103
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New Bern, North Carolina, United States, 28562
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Cary, North Carolina, United States, 27511
United States, Ohio
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Cleveland, Ohio, United States, 44122
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Mayfield Heights, Ohio, United States, 44124
United States, Oregon
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Medford, Oregon, United States, 97504
Duramed Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Duramed Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
United States, South Carolina
Duramed Investigational Site
Columbia, South Carolina, United States, 29201
Duramed Investigational Site
Charleston, South Carolina, United States, 29425
Duramed Investigational Site
Hilton Head Island, South Carolina, United States, 29926
United States, Tennessee
Duramed Investigational Site
Jackson, Tennessee, United States, 38305
United States, Texas
Duramed Investigational Site
San Antonio, Texas, United States, 78229
Duramed Investigational Site
Houston, Texas, United States, 77024
Duramed Investigational Site
Austin, Texas, United States, 78737
Duramed Investigational Site
Dallas, Texas, United States, 75390
United States, Utah
Duramed Investigational Site
Salt Lake City, Utah, United States, 84102
United States, Vermont
Duramed Investigational Site
Williston, Vermont, United States, 05495

Sponsors and Collaborators

Duramed Research

Investigators

Principal Investigator:

Duramed Medical Monitor

Duramed Research

More Information

No publications provided

Responsible Party:	Duramed Research, Inc ( Duramed Research )
Study ID Numbers:	DR-ASC-201
Study First Received:	October 30, 2006
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00394771 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

oral contraceptives
breakthrough bleeding
spotting

Additional relevant MeSH terms:

Metrorrhagia
Uterine Hemorrhage
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Uterine Diseases

Reproductive Control Agents
Hemorrhage
Pharmacologic Actions
Genital Diseases, Female
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2009