Birth Control Patch Study

Contraception Clinical Trial

Official title:

Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984789
• Other study ID #: 13082
• Secondary ID: 2008-007308-27
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2009
• Last updated: April 1, 2014
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteeNetherlands: Ethics CommitteeAustria:Medical Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)
0.55mg ethinylestradiol and 2.1mg gestodene
• Norelgestromin/Ethinylestradiol (EVRA)
0.6mg ethinylestradiol and 6mg norelgestromin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Parexel

Countries where clinical trial is conducted

Austria,  Czech Republic,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding Patterns and cycle control		7 cycles (each consisting of 28 days)	No
Secondary	Contraceptive efficacy		7 cycles (each consisting of 28 days) + follow up period of 14 days	No
Secondary	Adverse Event Collection		7 cycles (each consisting of 28 days)	Yes
Secondary	Population pharmacokinetics		7 cycles (each consisting of 28 days)	No
Secondary	Compliance to treatment		7 cycles (each consisting of 28 days)	No
Secondary	Subjective assessment of treatment		7 cycles (each consisting of 28 days)	No

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