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

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Gestodene/EE Patch (BAY86-5016)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00910637

310802 (Other Identifier)

91555

Details and patient eligibility

About

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

Enrollment: 1,502 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,502 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Gestodene/EE Patch (BAY86-5016)