Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
NCT ID: NCT00567164
Last Updated: 2014-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1887 participants
INTERVENTIONAL
2007-10-31
2009-11-30
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
PREVENTION
NONE
Study Groups
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Flexible (extended) regimen no. 1 of EE20/DRSP (BAY86-5300)
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
EE20/DRSP (BAY86-5300)
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Flexible (extended) regimen no. 2 of EE20/DRSP (BAY86-5300)
Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
EE20/DRSP (BAY86-5300)
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Conventional regimen of EE20/DRSP (YAZ, BAY86-5300)
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of tablets without active substance (together resulting in one cycle of 24+4 standard treatment). 13 withdrawal bleeding episodes during one year of treatment were expected.
EE20/DRSP (YAZ, BAY86-5300)
Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)
Interventions
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EE20/DRSP (BAY86-5300)
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
EE20/DRSP (BAY86-5300)
Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
EE20/DRSP (YAZ, BAY86-5300)
Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Montgomery, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Beverly Hills, California, United States
Pacific Palisades, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Ana, California, United States
Vallejo, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Greenwood Village, Colorado, United States
Littleton, Colorado, United States
Waterbury, Connecticut, United States
Boynton Beach, Florida, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Crystal River, Florida, United States
Jacksonville, Florida, United States
Lake Worth, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
North Miami, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
South Miami, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Boise, Idaho, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Newburgh, Indiana, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Marrero, Louisiana, United States
Paw Paw, Michigan, United States
Chesterfield, Missouri, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
LasVegas, Nevada, United States
Moorestown, New Jersey, United States
New Brunswick, New Jersey, United States
Rochester, New York, United States
Durham, North Carolina, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Bismarck, North Dakota, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Portland, Oregon, United States
Jenkintown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Columbia, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Chattanooga, Tennessee, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Colleyville, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
West Jordan, Utah, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Countries
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References
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Jensen JT, Garie SG, Trummer D, Elliesen J. Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Contraception. 2012 Aug;86(2):110-8. doi: 10.1016/j.contraception.2011.12.009. Epub 2012 Jan 26.
Other Identifiers
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311642
Identifier Type: OTHER
Identifier Source: secondary_id
91698
Identifier Type: -
Identifier Source: org_study_id
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