US Cycle Control and Blood Pressure Study

Study Overview
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Brief Summary
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Birth Control Patch Study

Official Title
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Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women

Conditions
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Contraception

Intervention / Treatment
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* Drug: Gestodene/EE (FC Patch Low, BAY86-5016)
* Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subject requesting contraception Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gestodene/EE (FC Patch Low, BAY86-5016)<br>* 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2<br>|
| Active Comparator: Arm 2<br> | Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A<br>* 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle control parameters and bleeding pattern indices |  | Treatment cycles 2-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pregnancies while on treatment up to 14 days after removal of the last patch |  | 7 treatment cycles each consisting of 28 days and follow-up period of 14 days | 
| Evaluation of blood pressure changes during the dosing-free interval |  | 7 treatment cycles each consisting of 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy prevention, Patch, Female contraception