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Completed

NCT Number: NCT00914693

EU/LA Pearl Index Study - Transdermal Contraceptive Patch

The aim of the present study is to prove efficacy and safety of a new contraceptive patch.

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Lanús Oeste, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Requiring contraception
  • Normal cervical smear
  • Smokers not older than 30 years
  • History of regular cyclic menstrual periods

Exclusion criteria

  • Pregnancy or lactation
  • Obesity (BMI> 30 kg/m2
  • 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

Ethinylestradiol/Gestodene (BAY86-5016)

Drug

7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Primary outcomes

  1. Occurrence of pregnancy

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

Secondary outcomes

  1. Cervical smear

    Time frame: 13 treatment cycles each consisting of 28 days

  2. Adverse events

    Time frame: 13 treatment cycles each consisting of 28 days

  3. Bleeding pattern and cycle control

    Time frame: 13 treatment cycles each consisting of 28 days

Other outcomes

  1. Treatment compliance

    Time frame: 13 treatment cycles each consisting of 28 days

  2. Subjective assessment of satisfaction with the treatment

    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 (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 5, 2009
Registry last updated
Dec 5, 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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