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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083264
First Posted: March 9, 2010
Last Update Posted: June 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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:


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) ]

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 ]
  • Adverse Events [ Time Frame: Week 1-5 of each treatment period ]

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
Experimental: Arm 1 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
Experimental: Arm 2 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
Experimental: Arm 3 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083264


Locations
Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01083264     History of Changes
Other Study ID Numbers: 91608
2009-011151-52 ( EudraCT Number )
First Submitted: March 8, 2010
First Posted: March 9, 2010
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by Bayer:
Pharmacokinetics

Additional relevant MeSH terms:
Ethinyl Estradiol
Gestodene
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Progestins