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Birth Control Patch Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00984789
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) Drug: Norelgestromin/Ethinylestradiol (EVRA) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA
Study Start Date : May 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bleeding Patterns and cycle control [ Time Frame: 7 cycles (each consisting of 28 days) ]

Secondary Outcome Measures :
  1. Contraceptive efficacy [ Time Frame: 7 cycles (each consisting of 28 days) + follow up period of 14 days ]
  2. Adverse Event Collection [ Time Frame: 7 cycles (each consisting of 28 days) ]
  3. Population pharmacokinetics [ Time Frame: 7 cycles (each consisting of 28 days) ]
  4. Compliance to treatment [ Time Frame: 7 cycles (each consisting of 28 days) ]
  5. Subjective assessment of treatment [ Time Frame: 7 cycles (each consisting of 28 days) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00984789

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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, 1050
Wien, Austria, 1090
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 10, Czech Republic, 109 00
Praha 2, Czech Republic, 120 00
Praha 7, Czech Republic, 170 00
Praha, Czech Republic, 13000
De Bilt, Netherlands, 3731 DN
Den Helder, Netherlands, 1782 GZ
Heerlen, Netherlands, 6401 MB
Nijmegen, Netherlands, 6525 EC
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT00984789    
Other Study ID Numbers: 13082
2008-007308-27 ( EudraCT Number )
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014
Keywords provided by Bayer:
Transdermal Patch
Additional relevant MeSH terms:
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Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Combined