Transdermal Contraceptive Patch - Endometrial Effects Study

Bayer

Status and phase: Completed; Phase 2

Conditions: Contraception

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00896571

14287

2009-010599-45 (EudraCT Number)

Details and patient eligibility

About

The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Enrollment: 92 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts 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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92 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Ethinylestradiol/Gestogene (BAY86-5016)