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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01083264
First received: March 8, 2010
Last updated: June 20, 2014
Last verified: June 2014
  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
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:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01083264     History of Changes
Other Study ID Numbers: 91608, 2009-011151-52
Study First Received: March 8, 2010
Last Updated: June 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Pharmacokinetics

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

ClinicalTrials.gov processed this record on October 22, 2014