Efficacy and Safety of Two Extended Regimens (Yaz Flex) in Comparison With the Conventional Regimen of YAZ

Condition(s) targeted: Healthy

Intervention: SH T00186D (Drug); SH T00186D (Drug); SH T00189D, SH T470PD (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trial Contact, Email: clinical-trials-contact@bayerhealthcare.com

The purpose of this study is to determine whether the study drug is safe and effective

Official title: A Multicenter, Open-Label, Three-Arm, Active-Controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D in Two Flexible Extended Regimens and a Conventional Regimen of Yaz in 1756 Healthy Females for 1 Year

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome: The primary efficacy variable is the number of observed unintended pregnancies during 1 year of treatment.

Secondary outcome: The secondary efficacy parameters include bleeding parameters and menstrual related symptoms.

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Bayer Clinical Trial Contact, Email: clinical-trials-contact@bayerhealthcare.com

Montgomery, Alabama 36116, United States; Active, not recruiting

Tucson, Arizona 85712, United States; Active, not recruiting

Phoenix, Arizona 85031, United States; Active, not recruiting

Chandler, Arizona 85224, United States; Active, not recruiting

Mesa, Arizona 85203, United States; Active, not recruiting

Tempe, Arizona 85283, United States; Recruiting

Tucson, Arizona 85741, United States; Recruiting

Mesa, Arizona 85201, United States; Recruiting

San Diego, California 92103, United States; Active, not recruiting

San Diego, California 92108, United States; Active, not recruiting

Pacific Palisades, California 90272, United States; Active, not recruiting

Anaheim, California 92801-2811, United States; Active, not recruiting

Beverly Hills, California 90212, United States; Active, not recruiting

Vallejo, California 94589, United States; Active, not recruiting

Santa Ana, California 92705, United States; Recruiting

Greenwood Village, Colorado 80111, United States; Terminated

Colorado Springs, Colorado 80909, United States; Active, not recruiting

Denver, Colorado 80202, United States; Active, not recruiting

Littleton, Colorado 80123, United States; Recruiting

Waterbury, Connecticut 06708, United States; Active, not recruiting

West Palm Beach, Florida 33409, United States; Active, not recruiting

Miami, Florida 33186, United States; Active, not recruiting

Pembroke Pines, Florida 33024, United States; Active, not recruiting

Clearwater, Florida 33759, United States; Active, not recruiting

Coral Gables, Florida 33134, United States; Active, not recruiting

South Miami, Florida 33143, United States; Active, not recruiting

Boynton Beach, Florida 33437, United States; Active, not recruiting

Jacksonville, Florida 32259, United States; Active, not recruiting

Crystal River, Florida 34429, United States; Active, not recruiting

Plantation, Florida 33313, United States; Terminated

North Miami, Florida 33161, United States; Recruiting

Brooksville, Florida 34613, United States; Recruiting

Lake Worth, Florida 33461, United States; Recruiting

St. Petersburg, Florida 33710, United States; Recruiting

Naples, Florida 34102, United States; Recruiting

Atlanta, Georgia 30328, United States; Active, not recruiting

Decatur, Georgia 30034, United States; Active, not recruiting

Idaho Falls, Idaho 83404, United States; Active, not recruiting

Boise, Idaho 83704, United States; Active, not recruiting

Boise, Idaho 83702, United States; Recruiting

Chicago, Illinois 60612, United States; Terminated

Champaign, Illinois 61820, United States; Active, not recruiting

Newburgh, Indiana 47630, United States; Active, not recruiting

Wichita, Kansas 67207, United States; Recruiting

Lexington, Kentucky 40509, United States; Active, not recruiting

Marrero, Louisiana 70072, United States; Active, not recruiting

Paw Paw, Michigan 49079, United States; Active, not recruiting

Chesterfield, Missouri 63017, United States; Active, not recruiting

Kansas City, Missouri 64114, United States; Recruiting

Lincoln, Nebraska 68510, United States; Active, not recruiting

LasVegas, Nevada 89106, United States; Active, not recruiting

Las Vegas, Nevada 89104, United States; Active, not recruiting

Las Vegas, Nevada 89117, United States; Recruiting

Moorestown, New Jersey 08057, United States; Active, not recruiting

New Brunswick, New Jersey 08901, United States; Not yet recruiting

Rochester, New York 14618, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Active, not recruiting

New Bern, North Carolina 28562, United States; Active, not recruiting

Durham, North Carolina 27713, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Recruiting

Bismarck, North Dakota 58501, United States; Terminated

Bismarck, North Dakota 58501, United States; Recruiting

Cleveland, Ohio 44122, United States; Active, not recruiting

Columbus, Ohio 43213, United States; Active, not recruiting

Oklahoma City, Oklahoma 73112, United States; Active, not recruiting

Portland, Oregon 97239, United States; Terminated

Portland, Oregon 97239, United States; Not yet recruiting

Pittsburgh, Pennsylvania 15206, United States; Active, not recruiting

Jenkintown, Pennsylvania 19046, United States; Active, not recruiting

Philadelphia, Pennsylvania 19114, United States; Active, not recruiting

Mt. Pleasant, South Carolina 29464, United States; Active, not recruiting

Columbia, South Carolina 29201, United States; Active, not recruiting

Knoxville, Tennessee 37920, United States; Active, not recruiting

Memphis, Tennessee 38120, United States; Active, not recruiting

Jackson, Tennessee 38301, United States; Active, not recruiting

Chattanooga, Tennessee 37404, United States; Active, not recruiting

Nashville, Tennessee 37203, United States; Active, not recruiting

Dallas, Texas 75234, United States; Active, not recruiting

Corpus Christi, Texas 78414, United States; Active, not recruiting

Houston, Texas, United States; Active, not recruiting

Houston, Texas 77074, United States; Active, not recruiting

Colleyville, Texas 76034, United States; Not yet recruiting

West Jordan, Utah 84088, United States; Active, not recruiting

Richmond, Virginia 23294, United States; Active, not recruiting

Richmond, Virginia 23233, United States; Active, not recruiting

Seattle, Washington 98105, United States; Active, not recruiting

Spokane, Washington 99207, United States; Active, not recruiting

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Starting date: October 2007
Ending date: December 2009
Last updated: October 20, 2008