US Cycle Control and Blood Pressure Study

Phase 3CompletedNCT00920985

Bayer346 enrolled

Overview

Birth Control Patch Study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

346

Conditions

Contraception

Interventions

Gestodene/EE (FC Patch Low, BAY86-5016)DRUG

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

Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593ADRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (28)

Unnamed facility

Chandler, Arizona, United States

Outcomes

Primary Outcomes

Cycle control parameters and bleeding pattern indices

Time frame: Treatment cycles 2-7

Secondary Outcomes

Number of pregnancies while on treatment up to 14 days after removal of the last patch

Time frame: 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

Time frame: 7 treatment cycles each consisting of 28 days

Data from ClinicalTrials.gov

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