Trial Condition(s):

Contraception

US Cycle Control and Blood Pressure Study

Bayer Identifier:

91556

ClinicalTrials.gov Identifier:

NCT00920985

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

Birth Control Patch Study

Inclusion Criteria
- Female subject requesting contraception
 - Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
 - Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
 - History of regular cyclic menstrual periods
Exclusion Criteria
- Pregnancy or lactation
 - Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
 - Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
 - Use of other contraceptive methods than study medication

Trial Summary

Enrollment Goal
346
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Clinical Trials Management, LLC

Metairie, United States, 70006

Status
Completed
Locations

University of Wisconsin - La Crosse

La Crosse, United States, 54691

Status
Completed
Locations

Clinical Trials Research Services, LLC

Pittsburgh, United States, 15206

Status
Completed
Locations

Elite Research Institute

Miami, United States, 33169

Status
Completed
Locations

Advanced Clinical Research Institute

Anaheim, United States, 92801

Status
Completed
Locations

Altus Research

Lake Worth, United States, 33461

Status
Completed
Locations

Soapstone Center for Clinical Research

Decatur, United States, 30034

Status
Completed
Locations

Precision Trials, LLC

Glendale, United States, 85304

Status
Completed
Locations

Clinical Research Center of Nevada

Las Vegas, United States, 89104

Status
Completed
Locations

Lyndhurst Gynecologic Associates

Winston-Salem, United States, 27103

Status
Completed
Locations

Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

Status
Completed
Locations

Associates in OB-GYN, Inc.

Cincinnati, United States, 45246

Status
Completed
Locations

Atlantic Institute of Clinical Research

Daytona Beach, United States, 32114

Status
Completed
Locations

Women's Medical Research Group, LLC

Clearwater, United States, 33759

Status
Completed
Locations

Robert Wood Johnson Medical School

New Brunswick, United States, 08901

Status
Completed
Locations

National Clinical Research, Inc.

Richmond, United States, 23294

Status
Completed
Locations

Beyer Research

Kalamazoo, United States, 49009

Status
Completed
Locations

Dr. Susan Floyd, MD

Wexford, United States, 15090

Status
Completed
Locations

New Ballas OB-GYN, Inc.

St. Louis, United States, 63141

Status
Completed
Locations

Visions Clinical Research - Tucson

Tucson, United States, 85712

Status
Completed
Locations

Seattle Women's: Health, Research, Gynecology

Seattle, United States, 98105

Status
Completed
Locations

Office of Dr. Alfred Moffett, MD

Leesburg, United States, 34748

Status
Completed
Locations

South Carolina Clinical Research Center

Columbia, United States, 29201

Status
Completed
Locations

Valley Women's Clinic

Renton, United States, 98055

Status
Completed
Locations

Star_W Research Center

Chandler, United States, 85225-2909

Status
Completed
Locations

Precision Trials

Phoenix, United States, 85032

Status
Completed
Locations

IGO Medical Group, AMC

San Diego, United States, 92121

Status
Completed
Locations

Altanta Women's Research Institute, Inc.

Atlanta, United States, 30342

Status
Completed

Trial Design