NCT00729404

Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (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

Detailed description

Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

Conditions

• Contraception
• Ovulation Inhibition

Interventions

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

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-08-07
• Last updated: 2014-12-02

Locations

3 sites across 1 country: Germany