check_circleStudy Completed
Contraception
Bayer Identifier:
13082
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Birth Control Patch Study
Trial purpose
400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of menstrual bleeding on these two treatments, plus how effective they are at preventing pregnancy, general safety, and their acceptability to the participants.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
393Trial Dates
May 2009 - September 2010Phase
Phase 3Could I Receive a placebo
NoProducts
Gestodene/EE Patch (BAY86-5016)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | HEERLEN, 6401 MB, Netherlands | |
Completed | DEN HELDER, 1782 GZ, Netherlands | |
Completed | NIJMEGEN, 6525 EC, Netherlands | |
Completed | Brno, 602 00, Czech Republic | |
Completed | Ceske Budejovice, 37001, Czech Republic | |
Completed | Praha 7, 170 00, Czech Republic | |
Completed | Hradec Kralove, 500 02, Czech Republic | |
Completed | Praha, 13000, Czech Republic | |
Completed | Praha 10, 109 00, Czech Republic | |
Completed | Bregenz, 6900, Austria | |
Completed | Wien, 1050, Austria | |
Completed | Graz, 8010, Austria | |
Completed | Mödling, 2340, Austria | |
Completed | De Bilt, 3731 DN, Netherlands | |
Completed | Pisek, 39701, Czech Republic | |
Completed | Olomouc, 772 00, Czech Republic | |
Completed | Praha 2, 120 00, Czech Republic | |
Completed | Wien, 1090, Austria | |
Completed | Graz, 8010, Austria | |
Completed | Zeltweg, 8740, Austria | |
Completed | Wörgl, 6300, Austria | |
Completed | Wiener Neustadt, 2700, Austria | |
Completed | Innsbruck, 6020, Austria | |
Completed | Graz, 8036, Austria |
Primary Outcome
- Bleeding Patterns and cycle controldate_rangeTime Frame:7 cycles (each consisting of 28 days)enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Contraceptive efficacydate_rangeTime Frame:7 cycles (each consisting of 28 days) + follow up period of 14 daysenhanced_encryptionnoSafety Issue:
- Adverse Event Collectiondate_rangeTime Frame:7 cycles (each consisting of 28 days)enhanced_encryptionyesSafety Issue:
- Population pharmacokineticsdate_rangeTime Frame:7 cycles (each consisting of 28 days)enhanced_encryptionnoSafety Issue:
- Compliance to treatmentdate_rangeTime Frame:7 cycles (each consisting of 28 days)enhanced_encryptionnoSafety Issue:
- Subjective assessment of treatmentdate_rangeTime Frame:7 cycles (each consisting of 28 days)enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2