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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00567164

Purpose

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

Condition	Intervention	Phase
Oral Contraception Healthy	Drug: Yaz (SH T00186D) Drug: SH T00186D Drug: SH T00189D, SH T470PD	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy variable is the number of observed unintended pregnancies during 1 year of treatment. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary efficacy parameters include bleeding parameters and menstrual related symptoms. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1756
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 2: Active Comparator	Drug: SH T00186D 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Arm 3: Active Comparator	Drug: SH T00189D, SH T470PD 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone + placebo tablet
Arm 1: Active Comparator	Drug: Yaz (SH T00186D) 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567164

Hide Study Locations

Locations

United States, Alabama

Montgomery, Alabama, United States, 36116
United States, Arizona

Tucson, Arizona, United States, 85712

Phoenix, Arizona, United States, 85031

Chandler, Arizona, United States, 85224

Mesa, Arizona, United States, 85203

Tempe, Arizona, United States, 85283

Tucson, Arizona, United States, 85741

Mesa, Arizona, United States, 85201
United States, California

San Diego, California, United States, 92103

San Diego, California, United States, 92108

Pacific Palisades, California, United States, 90272

Anaheim, California, United States, 92801-2811

Beverly Hills, California, United States, 90212

Vallejo, California, United States, 94589

Santa Ana, California, United States, 92705
United States, Colorado

Greenwood Village, Colorado, United States, 80111

Colorado Springs, Colorado, United States, 80909

Denver, Colorado, United States, 80202

Littleton, Colorado, United States, 80123
United States, Connecticut

Waterbury, Connecticut, United States, 06708

Waterbury, Connecticut, United States, 06708
United States, Florida

West Palm Beach, Florida, United States, 33409

Miami, Florida, United States, 33186

Pembroke Pines, Florida, United States, 33024

Clearwater, Florida, United States, 33759

Coral Gables, Florida, United States, 33134

South Miami, Florida, United States, 33143

Boynton Beach, Florida, United States, 33437

Brooksville, Florida, United States, 34613

Crystal River, Florida, United States, 34429

Plantation, Florida, United States, 33313

North Miami, Florida, United States, 33161

Jacksonville, Florida, United States, 32259

Lake Worth, Florida, United States, 33461

St. Petersburg, Florida, United States, 33710

Naples, Florida, United States, 34102
United States, Georgia

Atlanta, Georgia, United States, 30328

Decatur, Georgia, United States, 30034
United States, Idaho

Idaho Falls, Idaho, United States, 83404

Boise, Idaho, United States, 83704

Boise, Idaho, United States, 83702
United States, Illinois

Chicago, Illinois, United States, 60612

Champaign, Illinois, United States, 61820
United States, Indiana

Newburgh, Indiana, United States, 47630
United States, Kansas

Wichita, Kansas, United States, 67207
United States, Kentucky

Lexington, Kentucky, United States, 40509
United States, Louisiana

Marrero, Louisiana, United States, 70072
United States, Michigan

Paw Paw, Michigan, United States, 49079
United States, Missouri

Chesterfield, Missouri, United States, 63017

Kansas City, Missouri, United States, 64114
United States, Nebraska

Lincoln, Nebraska, United States, 68510
United States, Nevada

Las Vegas, Nevada, United States, 89117

Las Vegas, Nevada, United States, 89104

Las Vegas, Nevada, United States, 89117
United States, New Jersey

Moorestown, New Jersey, United States, 08057

New Brunswick, New Jersey, United States, 08901
United States, New York

Rochester, New York, United States, 14618
United States, North Carolina

Winston-Salem, North Carolina, United States, 27103

New Bern, North Carolina, United States, 28562

Durham, North Carolina, United States, 27713

Winston-Salem, North Carolina, United States, 27103
United States, North Dakota

Bismarck, North Dakota, United States, 58501

Bismarck, North Dakota, United States, 58501
United States, Ohio

Cleveland, Ohio, United States, 44122

Columbus, Ohio, United States, 43213
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73112
United States, Oregon

Portland, Oregon, United States, 97239

Portland, Oregon, United States, 97239
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15206

Jenkintown, Pennsylvania, United States, 19046

Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina

Mt. Pleasant, South Carolina, United States, 29464

Columbia, South Carolina, United States, 29201
United States, Tennessee

Knoxville, Tennessee, United States, 37920

Memphis, Tennessee, United States, 38120

Jackson, Tennessee, United States, 38301

Chattanooga, Tennessee, United States, 37404

Nashville, Tennessee, United States, 37203
United States, Texas

Dallas, Texas, United States, 75234

Corpus Christi, Texas, United States, 78414

Houston, Texas, United States

Houston, Texas, United States, 77074

Colleyville, Texas, United States, 76034
United States, Utah

West Jordan, Utah, United States, 84088
United States, Virginia

Richmond, Virginia, United States, 23294

Richmond, Virginia, United States, 23233
United States, Washington

Seattle, Washington, United States, 98105

Spokane, Washington, United States, 99207

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91698, 311642
Study First Received:	December 3, 2007
Last Updated:	October 9, 2009
ClinicalTrials.gov Identifier:	NCT00567164 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Oral Contraception
Birth Control pill
Healthy women requesting oral contraception
Contraceptive efficacy

ClinicalTrials.gov processed this record on November 30, 2009