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OpenTrials
Completed

NCT Number: NCT00910637

Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

This study is examining a birth control patch for 13 cycles (1 year).

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Requiring contraception
  • Normal cervical smear
  • Maximum age for smokers is 35
  • History of regular cyclic menstrual periods

Exclusion criteria

  • Pregnancy or lactation
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication

Treatment and study plan

Gestodene/EE Patch (BAY86-5016)

Drug

55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles

Primary outcomes

  1. Occurrence of pregnancy (yes/no) while on treatment

    Time frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary outcomes

  1. Vital signs

    Time frame: 13 treatment cycles each consisting of 28 days

  2. Physical and gynecological examinations

    Time frame: 13 treatment cycles each consisting of 28 days

  3. Laboratory assessments

    Time frame: 13 treatment cycles each consisting of 28 days

  4. Adverse events (AE monitoring)

    Time frame: 13 treatment cycles each consisting of 28 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 1, 2009
Registry last updated
Apr 8, 2021

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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