US Cycle Control and Blood Pressure Study

September 23, 2015 updated by: Bayer

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 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women

Birth Control Patch Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

346

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225-2909
      • Glendale, Arizona, United States, 85304
      • Phoenix, Arizona, United States, 85032
      • Tucson, Arizona, United States, 85712
    • California
      • Anaheim, California, United States, 92801
      • San Diego, California, United States, 92121
    • Florida
      • Clearwater, Florida, United States, 33759
      • Daytona Beach, Florida, United States, 32114
      • Lake Worth, Florida, United States, 33461
      • Leesburg, Florida, United States, 34748
      • Miami, Florida, United States, 33169
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Decatur, Georgia, United States, 30034
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
    • Missouri
      • St. Louis, Missouri, United States, 63141
    • Nevada
      • Las Vegas, Nevada, United States, 89104
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45246
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
      • Pittsburgh, Pennsylvania, United States, 15206
      • Wexford, Pennsylvania, United States, 15090
    • South Carolina
      • Columbia, South Carolina, United States, 29201
    • Virginia
      • Richmond, Virginia, United States, 23294
    • Washington
      • Renton, Washington, United States, 98055
      • Seattle, Washington, United States, 98105
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A
21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1
Experimental: Arm 1
Drug: Gestodene/EE (FC Patch Low, BAY86-5016)
21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cycle control parameters and bleeding pattern indices
Time Frame: Treatment cycles 2-7
Treatment cycles 2-7

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of pregnancies while on treatment up to 14 days after removal of the last patch
Time Frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Evaluation of blood pressure changes during the dosing-free interval
Time Frame: 7 treatment cycles each consisting of 28 days
7 treatment cycles each consisting of 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 15, 2009

First Posted (Estimate)

June 16, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91556

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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