Clinical trial NCT01621399: Safety and Efficacy Study to Treat Bacterial Vaginosis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Product 55394 in the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Lead sponsor: Medicis Global Service Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-18
Enrollment: 651
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Cure
timeFrame: Day 21
Secondary outcomes:
measure: Therapeutic Cure
timeFrame: Day 21
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: La Mesa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Groton
country: United States
state: Connecticut
city: Boyton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Marrero
country: United States
state: Louisiana
city: Falls River
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Lincoln
country: United States
state: Nebraska
city: Lawrenceville
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Plainsboro
country: United States
state: New Jersey
city: Columbus
country: United States
state: Ohio
city: Jenkintown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Schertz
country: United States
state: Texas
city: Williston
country: United States
state: Vermont
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Medicis Pharmaceutical
name: Ron Staugaard
role: STUDY_DIRECTOR
References: