Multi-Center Study of New Medications to Treat Vaginal Infections
- Registration Number
- NCT02308033
- Lead Sponsor
- Curatek Pharmaceuticals, LLC
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 204
- 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 Gel vehicle Gel vehicle One applicator full at bedtime
- Primary Outcome Measures
Name Time Method Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit 7-14 days after beginning treatment The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is 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
- Secondary Outcome Measures
Name Time Method Improvement of BV Clue Cells 7-14 days after beginning treatment Clue cells on wet mount were assessed and categorized as absent (\<20%) or present (\>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (\<20%).
Microbiologic Improvement/Cure 7-14 days after beginning treatment For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.
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
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.
Trial Locations
- Locations (35)
Women's Health CT Ob/Gyn
🇺🇸Bridgeport, Connecticut, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Women's Clinical Research Center
🇺🇸Seattle, Washington, United States
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Legacy Women's Health
🇺🇸Las Vegas, Nevada, United States
R. Garn Mabey Jr., MD Gynecology
🇺🇸Las Vegas, Nevada, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Atlanta North Gynecology
🇺🇸Roswell, Georgia, United States
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Red Rocks Ob/Gyn
🇺🇸Lakewood, Colorado, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Discovery Clinical Research
🇺🇸Plantation, Florida, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Rosemark Womens Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Mount Vernon CLinical Research
🇺🇸Sandy Springs, Georgia, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Women's Clinic of Lincoln
🇺🇸Lincoln, Nebraska, United States
Women's Health Research Center
🇺🇸Plainsboro, New Jersey, United States
Suffolk OB/GYN
🇺🇸Port Jefferson, New York, United States
Philapelphia Clinical Research, LLC
🇺🇸Philadelphia, Pennsylvania, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Gossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Women's Health Practice
🇺🇸Champaign, Illinois, United States
James T. Martin, MD
🇺🇸North Charleston, South Carolina, United States
TMC Life Research, Inc.
🇺🇸Houston, Texas, United States
Women's Healthcare Specialists, PC
🇺🇸Kalamazoo, Michigan, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Lawrence Ob/Gyn Clinical Research LLC
🇺🇸Lawrenceville, New Jersey, United States
East Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
MomDoc Womens Health Research
🇺🇸Scottsdale, Arizona, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Radiant Research
🇺🇸Columbus, Ohio, United States