Safety and Efficacy Study to Treat Bacterial Vaginosis

NCT ID: NCT01621399

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

651 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.

Detailed Description

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Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vehicle

Treatment with the vehicle (placebo)

Group Type PLACEBO_COMPARATOR

Placebo Vehicle (non-treatment)

Intervention Type DRUG

The vehicle vaginal gel in an applicator (placebo).

Product 55394

Treatment with product 55394

Group Type EXPERIMENTAL

Product 55394

Intervention Type DRUG

Product 55394 vaginal gel in a prefilled applicator.

Interventions

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Product 55394

Product 55394 vaginal gel in a prefilled applicator.

Intervention Type DRUG

Placebo Vehicle (non-treatment)

The vehicle vaginal gel in an applicator (placebo).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
* Other items as identified in the protocol.

Exclusion Criteria

* Have a known or suspected other infectious cause of vulvovaginitis.
* Other items as identified in the protocol.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medicis Global Service Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Staugaard

Role: STUDY_DIRECTOR

Medicis Pharmaceutical

Locations

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Birmingham, Alabama, United States

Site Status

Phoenix, Arizona, United States

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La Mesa, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Groton, Connecticut, United States

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Boyton Beach, Florida, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Sunrise, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Roswell, Georgia, United States

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Chicago, Illinois, United States

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Marrero, Louisiana, United States

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Falls River, Massachusetts, United States

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Detroit, Michigan, United States

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Saginaw, Michigan, United States

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Lincoln, Nebraska, United States

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Lawrenceville, New Jersey, United States

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Neptune City, New Jersey, United States

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Plainsboro, New Jersey, United States

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Columbus, Ohio, United States

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Jenkintown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Jackson, Tennessee, United States

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Corpus Christi, Texas, United States

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Houston, Texas, United States

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Schertz, Texas, United States

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Williston, Vermont, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Countries

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United States

Other Identifiers

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MP-1601-01

Identifier Type: -

Identifier Source: org_study_id