Clinical trial NCT00567164: Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
Official title: A Multicenter, Open-label, Three-arm, Active-controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Flexible Extended Regimens and a Conventional Regimen of YAZ in 1756 Healthy Females for 1 Year
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Ovulation Inhibition
Contraceptives, Oral
Keywords: Oral Contraception
Birth Control pill
Healthy women requesting oral contraception
Contraceptive efficacy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 1887
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the study drug is safe and effective.

Detailed description: The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.

Eligibility criteria: Inclusion Criteria:

- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.

Exclusion Criteria:

- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.

Primary outcomes:
measure: Pearl Index
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of Bleeding Days (Including Spotting Days)
timeFrame: Up to 1 year
measure: Number of Bleeding Days (Excluding Spotting Days)
timeFrame: Up to 1 year
measure: Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.
timeFrame: Day 1 to Day 90
measure: Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.
timeFrame: Day 91 to Day 180
measure: Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3
timeFrame: Day 181 to Day 270
measure: Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4
timeFrame: Day 271 to Day 360
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13
timeFrame: Up to 1 year
measure: Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14
timeFrame: Up to 1 year
measure: Number of Intracyclic Bleeding Days
timeFrame: Up to 1 year
measure: Number of Scheduled and Unscheduled Bleeding Days
timeFrame: Up to 1 year
measure: Length of Cycles
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Pacific Palisades
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Vallejo
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Greenwood Village
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Crystal River
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Boise
country: United States
state: Idaho
city: Idaho Falls
country: United States
state: Idaho
city: Champaign
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Newburgh
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Marrero
country: United States
state: Louisiana
city: Paw Paw
country: United States
state: Michigan
city: Chesterfield
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: LasVegas
country: United States
state: Nevada
city: Moorestown
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Jenkintown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Colleyville
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: West Jordan
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.