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Completed

NCT Number: NCT00984789

Birth Control Patch Study

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.

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Key information

Conditions

Contraception Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mödling, Lower Austria, Austria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)

Drug

0.55mg ethinylestradiol and 2.1mg gestodene

Norelgestromin/Ethinylestradiol (EVRA)

Drug

0.6mg ethinylestradiol and 6mg norelgestromin

Primary outcomes

  1. Bleeding Patterns and cycle control

    Time frame: 7 cycles (each consisting of 28 days)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Parexel

Registry information

Official study title

Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 25, 2009
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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