Trial Condition(s):
Contraception
Birth Control Patch Study
Bayer Identifier:
13082
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site HEERLEN, Netherlands, 6401 MB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DEN HELDER, Netherlands, 1782 GZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 EC | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brno, Czech Republic, 602 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ceske Budejovice, Czech Republic, 37001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 7, Czech Republic, 170 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hradec Kralove, Czech Republic, 500 02 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha, Czech Republic, 13000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 10, Czech Republic, 109 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bregenz, Austria, 6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mödling, Austria, 2340 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site De Bilt, Netherlands, 3731 DN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisek, Czech Republic, 39701 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olomouc, Czech Republic, 772 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 120 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zeltweg, Austria, 8740 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wörgl, Austria, 6300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wiener Neustadt, Austria, 2700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Transdermal contraception patch: EU cycle control study versus EVRA
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Bleeding Patterns and cycle controlTimeframe: 7 cycles (each consisting of 28 days)
Secondary Outcome
- Contraceptive efficacyTimeframe: 7 cycles (each consisting of 28 days) + follow up period of 14 days
- Adverse Event CollectionTimeframe: 7 cycles (each consisting of 28 days)
- Population pharmacokineticsTimeframe: 7 cycles (each consisting of 28 days)
- Compliance to treatmentTimeframe: 7 cycles (each consisting of 28 days)
- Subjective assessment of treatmentTimeframe: 7 cycles (each consisting of 28 days)
Additional Information
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