Birth Control Patch Study

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00984789
First received: September 4, 2009
Last updated: April 1, 2014
Last verified: April 2014
  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
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, see Learn About Clinical Studies.

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: Bayer
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, 2014
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, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Progestins

ClinicalTrials.gov processed this record on August 01, 2014