Birth Control Patch Study
This study has been completed.
Sponsor:
Bayer
Collaborator:
Parexel
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00984789
First received: September 4, 2009
Last updated: April 1, 2013
Last verified: April 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Contraception |
Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) Drug: Norelgestromin/Ethinylestradiol (EVRA) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Bleeding Patterns and cycle control [ Time Frame: 7 cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Contraceptive efficacy [ Time Frame: 7 cycles (each consisting of 28 days) + follow up period of 14 days ] [ Designated as safety issue: No ]
- Adverse Event Collection [ Time Frame: 7 cycles (each consisting of 28 days) ] [ Designated as safety issue: Yes ]
- Population pharmacokinetics [ Time Frame: 7 cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
- Compliance to treatment [ Time Frame: 7 cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
- Subjective assessment of treatment [ Time Frame: 7 cycles (each consisting of 28 days) ] [ Designated as safety issue: No ]
| Enrollment: | 393 |
| Study Start Date: | May 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)
0.55mg ethinylestradiol and 2.1mg gestodene
|
| Active Comparator: Arm 2 |
Drug: Norelgestromin/Ethinylestradiol (EVRA)
0.6mg ethinylestradiol and 6mg norelgestromin
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984789
Locations
| Austria | |
| Mödling, Niederösterreich, Austria, 2340 | |
| Wiener Neustadt, Niederösterreich, Austria, 2700 | |
| Graz, Steiermark, Austria, 8036 | |
| Wörgl, Tirol, Austria, 6300 | |
| Bregenz, Vorarlberg, Austria, 6900 | |
| Graz, Austria, 8010 | |
| Innsbruck, Austria, 6020 | |
| Wien, Austria, 1090 | |
| Wien, Austria, 1050 | |
| Zeltweg, Austria, 8740 | |
| Czech Republic | |
| Brno, Czech Republic, 602 00 | |
| Ceske Budejovice, Czech Republic, 37001 | |
| Hradec Kralove, Czech Republic, 500 02 | |
| Olomouc, Czech Republic, 77900 | |
| Pisek, Czech Republic, 39701 | |
| Praha, Czech Republic, 13000 | |
| Praha 10, Czech Republic, 109 00 | |
| Praha 2, Czech Republic, 120 00 | |
| Praha 7, Czech Republic, 170 00 | |
| Netherlands | |
| De Bilt, Netherlands, 3731 DN | |
| Den Helder, Netherlands, 1782 GZ | |
| Heerlen, Netherlands, 6401 MB | |
| Nijmegen, Netherlands, 6525 EC | |
Sponsors and Collaborators
Bayer
Parexel
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00984789 History of Changes |
| Other Study ID Numbers: | 13082, 2008-007308-27 |
| Study First Received: | September 4, 2009 |
| Last Updated: | April 1, 2013 |
| Health Authority: | Czech Republic: Ethics Committee Netherlands: Ethics Committee Austria:Medical Ethics Review Committee |
Keywords provided by Bayer:
|
Transdermal Patch Bleeding Pregnancy |
Additional relevant MeSH terms:
|
Ethinyl Estradiol Gestodene Femovan Norelgestromin Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptives, Oral, Combined Progestins |
ClinicalTrials.gov processed this record on May 19, 2013