Trial Condition(s):

Contraception

Birth Control Patch Study

Bayer Identifier:

13082

ClinicalTrials.gov Identifier:

NCT00984789

EudraCT Number:

2008-007308-27

Study Completed

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.

Inclusion Criteria
- Healthy women requesting contraception aged 18-35 years old
 - Smokers must not be older than 30 at time of informed consent
 - History of regular cyclic menstrual periods, normal cervical smear
Exclusion Criteria
- Pregnancy or lactation
 - Obesity (BMI>30), hypersensitivity to any ingredients of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/accumulation/ metabolism/excretion of the study drug), any diseases / conditions that may worsen under hormonal treatment

Trial Summary

Enrollment Goal
393
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

HEERLEN, Netherlands, 6401 MB

Status
Completed
 
Locations

Investigative Site

DEN HELDER, Netherlands, 1782 GZ

Status
Completed
 
Locations

Investigative Site

NIJMEGEN, Netherlands, 6525 EC

Status
Completed
 
Locations

Investigative Site

Brno, Czech Republic, 602 00

Status
Completed
 
Locations

Investigative Site

Ceske Budejovice, Czech Republic, 37001

Status
Completed
 
Locations

Investigative Site

Praha 7, Czech Republic, 170 00

Status
Completed
 
Locations

Investigative Site

Hradec Kralove, Czech Republic, 500 02

Status
Completed
 
Locations

Investigative Site

Praha, Czech Republic, 13000

Status
Completed
 
Locations

Investigative Site

Praha 10, Czech Republic, 109 00

Status
Completed
 
Locations

Investigative Site

Bregenz, Austria, 6900

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1050

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8010

Status
Completed
 
Locations

Investigative Site

Mödling, Austria, 2340

Status
Completed
 
Locations

Investigative Site

De Bilt, Netherlands, 3731 DN

Status
Completed
 
Locations

Investigative Site

Pisek, Czech Republic, 39701

Status
Completed
 
Locations

Investigative Site

Olomouc, Czech Republic, 772 00

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 120 00

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Zeltweg, Austria, 8740

Status
Completed
 
Locations

Investigative Site

Wörgl, Austria, 6300

Status
Completed
 
Locations

Investigative Site

Wiener Neustadt, Austria, 2700

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 

Trial Design