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OpenTrials
Completed

NCT Number: NCT01083264

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

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

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, State of Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gestodene/EE Patch (BAY86-5016)

Drug

Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Adverse Events

    Time frame: Week 1-5 of each treatment period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 9, 2010
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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