Multi-Center Study of New Medications to Treat Vaginal Infections
- Conditions
- Vaginal Infection
- Interventions
- Registration Number
- NCT02308007
- Lead Sponsor
- Curatek Pharmaceuticals, LLC
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 475
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metronidazole vaginal gel Metronidazole One applicator full at bedtime Terconazole/metronidazole vaginal gel Terconazole/metronidazole One applicator full at bedtime Terconazole vaginal gel Terconazole One applicator full at bedtime
- Primary Outcome Measures
Name Time Method Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit 7-14 days after beginning treatment The percentage of participants with clinical cure of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is \<20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis
- Secondary Outcome Measures
Name Time Method Cure of the VVC Component of Mixed Infection 7-14 days after beginning treatment The percentage of participants with both BV and VVC who had clinical cure of VVC was compared between the combination therapy and the two single entity treatments.Clinical cure of VVC was defined as complete resolution of all signs and symptoms attributable to VVC
Microbiologic and Mycologic Cure 7-14 days after beginning treatment The percentage of participants with both microbiologic and mycologic cure was compared between the combination therapy and the two single entity treatments. Yeast cultures were performed and Gram stains of vaginal fluid were graded according to Nugent's criteria. Microbiologic cure requires normal Nugent gram stain score and mycologic cure requires negative yeast culture.
Cure of the BV Component of Mixed Infection 7-14 days after beginning treatment The percentage of participants with both BV and VVC who had clinical cure of bacterial vaginosis (BV) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV was defined as: 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is \<20% clue cells
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit 7-14 days after beginning treatment Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.
Number of Participants With Treatment Emergent Adverse Events Any time during study participation (up to 30 days) Adverse events were collected at study visits, from subject diaries and from spontaneous reports
Trial Locations
- Locations (51)
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Mount Vernon CLinical Research
🇺🇸Sandy Springs, Georgia, United States
Women's Health Practice
🇺🇸Champaign, Illinois, United States
Atlanta North Gynecology
🇺🇸Roswell, Georgia, United States
Suffolk OB/GYN
🇺🇸Port Jefferson, New York, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Discovery Clinical Trials
🇺🇸Dallas, Texas, United States
Signature Gyn Services
🇺🇸Fort Worth, Texas, United States
Complete Healthcare for Women
🇺🇸Columbus, Ohio, United States
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Children's Hospital for Women
🇺🇸Houston, Texas, United States
TMC Life Research, Inc.
🇺🇸Houston, Texas, United States
Women's Clinical Research Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
MomDoc Womens Health Research
🇺🇸Scottsdale, Arizona, United States
Rosemark Womens Care Specialists
🇺🇸Idaho Falls, Idaho, United States
DelSol Research
🇺🇸Tucson, Arizona, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Precision Clinical Research
🇺🇸Coral Springs, Florida, United States
Women's Health CT Ob/Gyn
🇺🇸Bridgeport, Connecticut, United States
Southern Clinical Research Associates
🇺🇸Metairie, Louisiana, United States
KO Clinical Research, LLC
🇺🇸Fort Lauderdale, Florida, United States
Discovery Clinical Research
🇺🇸Plantation, Florida, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Praetorian Pharmaceutical Research, LLC
🇺🇸Marrero, Louisiana, United States
Women's Health Research Center
🇺🇸Plainsboro, New Jersey, United States
Women Under Study
🇺🇸New Orleans, Louisiana, United States
Lawrence Ob/Gyn Clinical Research LLC
🇺🇸Lawrenceville, New Jersey, United States
Women's Healthcare Specialists, PC
🇺🇸Kalamazoo, Michigan, United States
Women's Clinic of Lincoln
🇺🇸Lincoln, Nebraska, United States
Magnolia Ob/Gyn Research Center
🇺🇸Myrtle Beach, South Carolina, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
James T. Martin, MD
🇺🇸North Charleston, South Carolina, United States
Gossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Philapelphia Clinical Research, LLC
🇺🇸Philadelphia, Pennsylvania, United States
East Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Red Rocks Ob/Gyn
🇺🇸Lakewood, Colorado, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Legacy Women's Health
🇺🇸Las Vegas, Nevada, United States
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Precision Trials, AZ
🇺🇸Phoenix, Arizona, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
R. Garn Mabey Jr., MD Gynecology
🇺🇸Las Vegas, Nevada, United States
Radiant Research
🇺🇸Columbus, Ohio, United States