Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites - Tabular View

Tracking Information

First Received Date ^ICMJE

March 8, 2010

Last Updated Date

July 14, 2011

Start Date ^ICMJE

October 2009

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

AUC(0-168) for EE and Gestodene during week 4 of each treatment period [ Time Frame: Week 4 of each treatment period ( 3 periods) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01083264 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week [ Time Frame: Week 1-5 of each treatment period ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: Week 1-5 of each treatment period ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites

Official Title ^ICMJE

Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Transdermally Administered Ethinylestradiol (EE) and Gestodene (GSD) After Repeated Applications of a Fertility Control Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene to 3 Different Application Sites (Buttocks, Arm Versus Abdomen) in Healthy Young Female Subjects

Brief Summary

Influence of different application sites on the blood levels after administration of a fertility control patch

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase I

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Contraception

Intervention ^ICMJE

Drug: Gestodene/EE Patch (BAY86-5016)
Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks
Drug: Gestodene/EE Patch (BAY86-5016)
Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm
Drug: Gestodene/EE Patch (BAY86-5016)
Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen

Study Arms

Experimental: Arm 1
Intervention: Drug: Gestodene/EE Patch (BAY86-5016)
Experimental: Arm 2
Intervention: Drug: Gestodene/EE Patch (BAY86-5016)
Experimental: Arm 3
Intervention: Drug: Gestodene/EE Patch (BAY86-5016)

Publications *

* 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

May 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy female subjects
Age 18-45 years
Body mass index (BMI) 18-30kg/m²
At least 3 months since delivery, abortion, or lactation before the first screening examination
Ability to understand and follow study-related instructions
Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods

Exclusion Criteria:

Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
Regular use of medicines other than contraceptives
Smokers (at the age of 31 to 45 years)
Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01083264

Other Study ID Numbers ^ICMJE

91608, EudraCT:2009-011151-52

Has Data Monitoring Committee

Responsible Party

Head Clinical Pharmacology, Bayer HealthCare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2011

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