A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
NCT ID: NCT00394771
Last Updated: 2013-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
567 participants
INTERVENTIONAL
2006-10-31
2008-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Low Dose DR-1031
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Midrange Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
High Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Seasonale®
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Interventions
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DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Seasonale®
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
Portia®
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not pregnant or breastfeeding
* Agree to use back-up non-hormonal contraception for study period
Exclusion Criteria
* Pregnancy within the last 3 months
* Smoking \>10 cigarettes per day
18 Years
45 Years
FEMALE
Yes
Sponsors
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Duramed Research
INDUSTRY
Responsible Party
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Principal Investigators
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Duramed Medical Monitor
Role: PRINCIPAL_INVESTIGATOR
Duramed Research
Locations
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Duramed Investigational Site
Huntsville, Alabama, United States
Duramed Investigational Site
Tucson, Arizona, United States
Duramed Investigational Site
Little Rock, Arkansas, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Vista, California, United States
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Pueblo, Colorado, United States
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Stratford, Connecticut, United States
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DeLand, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Miami, 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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West Palm Beach, Florida, United States
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Alpharetta, Georgia, United States
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Douglasville, Georgia, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Meridian, Idaho, United States
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Fort Wayne, Indiana, United States
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Wichita, Kansas, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Riverdale, Maryland, United States
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Kansas City, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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North Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Cary, North Carolina, United States
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New Bern, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Mayfield Heights, Ohio, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Hilton Head Island, South Carolina, United States
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Jackson, 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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Salt Lake City, Utah, United States
Duramed Investigational Site
Williston, Vermont, United States
Countries
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Other Identifiers
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DR-ASC-201
Identifier Type: -
Identifier Source: org_study_id
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