Clinical trial NCT02308007: Multi-Center Study of New Medications to Treat Vaginal Infections
Official title: Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginal Infection
Lead sponsor: Curatek Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 475
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
* Capable of providing written informed consent or assent
* Currently not menstruating and not anticipating menses during treatment
* If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
* Negative pregnancy test
* Other criteria as identified in the protocol

Exclusion Criteria:

* Other infectious causes of vulvovaginitis
* Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
* Nursing mother
* Use of any investigational drug within 30 days of enrollment
* History of hypersensitivity to any ingredient/component of the formulations
* Other criteria as identified in the protocol

Primary outcomes:
measure: Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit
timeFrame: 7-14 days after beginning treatment
Secondary outcomes:
measure: Cure of the BV Component of Mixed Infection
timeFrame: 7-14 days after beginning treatment
measure: Cure of the VVC Component of Mixed Infection
timeFrame: 7-14 days after beginning treatment
measure: Microbiologic and Mycologic Cure
timeFrame: 7-14 days after beginning treatment
measure: Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
timeFrame: 7-14 days after beginning treatment
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: Any time during study participation (up to 30 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials, AZ
state: Arizona
city: Scottsdale
country: United States
facility: MomDoc Womens Health Research
state: Arizona
city: Tucson
country: United States
facility: DelSol Research
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: La Mesa
country: United States
facility: Gossmont Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Lakewood
country: United States
facility: Red Rocks Ob/Gyn
state: Colorado
city: Bridgeport
country: United States
facility: Women's Health CT Ob/Gyn
state: Connecticut
city: Coral Springs
country: United States
facility: Precision Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Plantation
country: United States
facility: Discovery Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Roswell
country: United States
facility: Atlanta North Gynecology
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon CLinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark Womens Care Specialists
state: Idaho
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research, LLC
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study
state: Louisiana
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Kalamazoo
country: United States
facility: Women's Healthcare Specialists, PC
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln
state: Nebraska
city: Las Vegas
country: United States
facility: Legacy Women's Health
state: Nevada
city: Las Vegas
country: United States
facility: R. Garn Mabey Jr., MD Gynecology
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence Ob/Gyn Clinical Research LLC
state: New Jersey
city: Plainsboro
country: United States
facility: Women's Health Research Center
state: New Jersey
city: Port Jefferson
country: United States
facility: Suffolk OB/GYN
state: New York
city: New Bern
country: United States
facility: East Carolina Women's Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philapelphia Clinical Research, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Magnolia Ob/Gyn Research Center
state: South Carolina
city: North Charleston
country: United States
facility: James T. Martin, MD
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Dallas
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Fort Worth
country: United States
facility: Signature Gyn Services
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital for Women
state: Texas
city: Houston
country: United States
facility: TMC Life Research, Inc.
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
Study officials:
affiliation: Curatek Pharmaceuticals
name: Robert J Borgman, Ph.D.
role: STUDY_DIRECTOR
References: