Transdermal Contraceptive Patch - Endometrial Effects Study

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00896571

First received: May 8, 2009

Last updated: December 12, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2009

Last Updated Date

December 12, 2012

Start Date ^ICMJE

July 2009

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effect on the endometrium at cycle 13 [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00896571 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cervical smear [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
Cycle control [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
Safety laboratory [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
Occurence of pregnancy [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Treatment compliance [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
Subjective assessment of satisfaction with the treatment [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
Cervical smear [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
Cycle control [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
Safety laboratory [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
Occurence of pregnancy [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Treatment compliance [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
Subjective assessment of satisfaction with the treatment [ Time Frame: 13 treatment cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Transdermal Contraceptive Patch - Endometrial Effects Study

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Contraception

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Arm 1

Intervention: Drug: Ethinylestradiol/Gestogene (BAY86-5016)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00896571

Other Study ID Numbers ^ICMJE

14287, 2009-010599-45

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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