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

Phase 1

Completed

• Conditions: Contraception
• Interventions: Drug: Gestodene/EE Patch (BAY86-5016)

• Registration Number: NCT01083264
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 2	Gestodene/EE Patch (BAY86-5016)	-
Arm 3	Gestodene/EE Patch (BAY86-5016)	-
Arm 1	Gestodene/EE Patch (BAY86-5016)	-

Primary Outcome Measures

Name	Time	Method
AUC(0-168) for EE and Gestodene during week 4 of each treatment period	Week 4 of each treatment period ( 3 periods)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Week 1-5 of each treatment period
Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week	Week 1-5 of each treatment period