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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083264
• Other study ID #: 91608
• Secondary ID: 2009-011151-52
• Status: Completed
• Phase: Phase 1
• First received: March 8, 2010
• Last updated: June 20, 2014
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Contraception

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-168) for EE and Gestodene during week 4 of each treatment period		Week 4 of each treatment period ( 3 periods)	No
Secondary	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	No
Secondary	Adverse Events		Week 1-5 of each treatment period	Yes

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