US Cycle Control and Blood Pressure Study

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Gestodene/EE (FC Patch Low, BAY86-5016); Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A

• Registration Number: NCT00920985
• Lead Sponsor: Bayer

Brief Summary

Birth Control Patch Study

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2014-01
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-09
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 346

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Gestodene/EE (FC Patch Low, BAY86-5016)	-
Arm 2	Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A	-

Primary Outcome Measures

Name	Time	Method
Cycle control parameters and bleeding pattern indices	Treatment cycles 2-7

Secondary Outcome Measures

Name	Time	Method
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