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US Cycle Control and Blood Pressure Study

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Gestodene/EE (FC Patch Low, BAY86-5016) (Drug); Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

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

Summary

Birth Control Patch Study

Clinical Details

Official title: Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 g Ethinylestradiol and 100 g Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Cycle control parameters and bleeding pattern indices

Secondary outcome:

Number of pregnancies while on treatment up to 14 days after removal of the last patch

Evaluation of blood pressure changes during the dosing-free interval

Eligibility

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

Criteria:

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

Locations and Contacts

Chandler, Arizona 85225-2909, United States

Glendale, Arizona 85304, United States

Phoenix, Arizona 85032, United States

Tucson, Arizona 85712, United States

Anaheim, California 92801, United States

San Diego, California 92121, United States

Clearwater, Florida 33759, United States

Daytona Beach, Florida 32114, United States

Lake Worth, Florida 33461, United States

Leesburg, Florida 34748, United States

Miami, Florida 33169, United States

Atlanta, Georgia 30342, United States

Decatur, Georgia 30034, United States

Metairie, Louisiana 70006, United States

Kalamazoo, Michigan 49009, United States

St. Louis, Missouri 63141, United States

Las Vegas, Nevada 89104, United States

New Brunswick, New Jersey 08901, United States

Winston-Salem, North Carolina 27103, United States

Cincinnati, Ohio 45246, United States

Philadelphia, Pennsylvania 19114, United States

Pittsburgh, Pennsylvania 15206, United States

Wexford, Pennsylvania 15090, United States

Columbia, South Carolina 29201, United States

Richmond, Virginia 23294, United States

Renton, Washington 98055, United States

Seattle, Washington 98105, United States

La Crosse, Wisconsin 54691, United States

Additional Information

Click here and search for drug information provided by the FDA.

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Starting date: June 2009
Last updated: January 27, 2014

Page last updated: August 23, 2015

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