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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT01083264

Purpose

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

Condition	Intervention	Phase
Contraception	Drug: Gestodene/EE Patch (BAY86-5016)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control Infertility

Drug Information available for: Ethinyl estradiol Gestodene

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	43
Study Start Date:	October 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	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
Arm 2: Experimental	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
Arm 3: Experimental	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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083264

Locations

Germany

Berlin, Germany, 13342

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Head Clinical Pharmacology )
ClinicalTrials.gov Identifier:	NCT01083264 History of Changes
Other Study ID Numbers:	91608, EudraCT:2009-011151-52
Study First Received:	March 8, 2010
Last Updated:	July 12, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Pharmacokinetics

Additional relevant MeSH terms:

Ethinyl Estradiol
Gestodene
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Progestins

ClinicalTrials.gov processed this record on September 01, 2010