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Birth Control Patch Study

NCT00984789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2014-04-02

No results posted yet for this study

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.

Conditions

  • Contraception

Interventions

DRUG

Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)

0.55mg ethinylestradiol and 2.1mg gestodene

DRUG

Norelgestromin/Ethinylestradiol (EVRA)

0.6mg ethinylestradiol and 6mg norelgestromin

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Austria
  • Czechia
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00984789 on ClinicalTrials.gov