Transdermal Contraceptive Patch - Endometrial Effects Study

November 24, 2014 updated by: Bayer

Single-center,Open-label, Uncontrolled Study to Investigate the Effects of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene on the Endometrium in a 21-day Regimen for 13 Cycles in 80 Healthy Women

The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

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

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Requiring contraception
  • Normal cervical smear
  • Smokers not older than 30 years
  • History of regular cyclic menstrual periods

Exclusion Criteria:

  • Pregnancy or lactation
  • Obesity (BMI> 30 kg/m2)
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Ethinylestradiol/Gestogene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on the endometrium at cycle 13
Time Frame: 13 treatment cycles (each consisting of 28 days)
13 treatment cycles (each consisting of 28 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Cervical smear
Time Frame: 13 treatment cycles (each consisting of 28 days)
13 treatment cycles (each consisting of 28 days)
Adverse events
Time Frame: 13 treatment cycles (each consisting of 28 days)
13 treatment cycles (each consisting of 28 days)
Cycle control
Time Frame: 13 treatment cycles (each consisting of 28 days)
13 treatment cycles (each consisting of 28 days)
Safety laboratory
Time Frame: 13 treatment cycles (each consisting of 28 days)
13 treatment cycles (each consisting of 28 days)
Occurence of pregnancy
Time Frame: 13 treatment cycles (each consisting of 28 days)
13 treatment cycles (each consisting of 28 days)

Other Outcome Measures

Outcome Measure
Time Frame
Treatment compliance
Time Frame: 13 treatment cycles (each consisting of 28 days)
13 treatment cycles (each consisting of 28 days)
Subjective assessment of satisfaction with the treatment
Time Frame: 13 treatment cycles (each consisting of 28 days)
13 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.

Helpful Links

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

July 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 8, 2009

First Posted (Estimate)

May 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14287
  • 2009-010599-45 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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Locations

3
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