NCT00915915

Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol and Either 1.05 or 2.1 mg Gestodene in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Conditions

• Contraception
• Ovulation Inhibition

Interventions

Type	Name	Description
DRUG	Ethinylestradiol/Gestodene (BAY86-5016)	Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)
DRUG	Ethinylestradiol/Gestodene (BAY86-5016)	Transdermal patch: 0.55mg Ethinylestradiol (EE+1.05mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-06-08
• Last updated: 2014-10-28

Locations

2 sites across 1 country: Germany