check_circleStudy Completed
Contraception
Bayer Identifier:
91608
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Relative bioavailability, transdermally administered EE and GSD, 3 applications sites
Trial purpose
Influence of different application sites on the blood levels after administration of a fertility control patch
Key Participants Requirements
Sex
FemaleAge
18 - 45 YearsTrial summary
Enrollment Goal
43Trial Dates
October 2009 - May 2010Phase
Phase 1Could I Receive a placebo
NoProducts
Gestodene/EE Patch (BAY86-5016)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bayer Pharma AG | Berlin, 13353, Germany |
Primary Outcome
- AUC(0-168) for EE and Gestodene during week 4 of each treatment perioddate_rangeTime Frame:Week 4 of each treatment period ( 3 periods)enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each weekdate_rangeTime Frame:Week 1-5 of each treatment periodenhanced_encryptionnoSafety Issue:
- Adverse Eventsdate_rangeTime Frame:Week 1-5 of each treatment periodenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
3