EU/LA Pearl Index Study - Transdermal Contraceptive Patch

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00914693
• Date of registration: 05/05/2009
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: EU/LA Pearl Index Study - Transdermal Contraceptive Patch
• Scientific 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
• Date of first enrolment: April 2009
• Target sample size: 1694
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00914693
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Chile, France, Germany, Italy, Mexico, Spain

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

Intervention(s)

Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Primary Outcome(s)

Occurrence of pregnancy [Time Frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days]

Secondary Outcome(s)

Bleeding pattern and cycle control [Time Frame: 13 treatment cycles each consisting of 28 days]

Adverse events [Time Frame: 13 treatment cycles each consisting of 28 days]

Cervical smear [Time Frame: 13 treatment cycles each consisting of 28 days]

Secondary ID(s)

310801

91554

2008-004214-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors