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

Phase 3CompletedNCT00910637

Bayer1,502 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,502

Conditions

Contraception

Interventions

Gestodene/EE Patch (BAY86-5016)DRUG

55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 13 cycles

Eligibility

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

Medical Language ↔ Plain English

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

Locations (63)

Outcomes

Primary Outcomes

Occurrence of pregnancy (yes/no) while on treatment

Time frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcomes

Vital signs

Time frame: 13 treatment cycles each consisting of 28 days

Physical and gynecological examinations

Time frame: 13 treatment cycles each consisting of 28 days

Laboratory assessments

Time frame: 13 treatment cycles each consisting of 28 days

Adverse events (AE monitoring)

Time frame: 13 treatment cycles each consisting of 28 days

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Glendale, Arizona, United States

Precision Trials

Phoenix, Arizona, United States

Visions Clinical Research - Tucson

Tucson, Arizona, United States

Unnamed facility

Carmichael, California, United States

Unnamed facility

Pacific Palisades, California, United States

Unnamed facility

Paramount, California, United States

Genesis Center for Clinical Research

San Diego, California, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

San Diego, California, United States

...and 53 more locations