EU/LA Pearl Index Study - Transdermal Contraceptive Patch

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Ethinylestradiol/Gestodene (BAY86-5016)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914693

2008-004214-27 (EudraCT Number)

91554

310801 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,694 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,694 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Ethinylestradiol/Gestodene (BAY86-5016)