- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02308033
Multi-Center Study of New Medications to Treat Vaginal Infections (SMART GIVES)
July 9, 2020 updated by: Curatek Pharmaceuticals, LLC
Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama
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Arizona
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Scottsdale, Arizona, United States, 85251
- MomDoc Womens Health Research
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- NEA Baptist Clinic
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California
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La Mesa, California, United States, 91942
- Gossmont Center for Clinical Research
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San Diego, California, United States, 92108
- Medical Center for Clinical Research
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San Diego, California, United States, 92103
- Genesis Center for Clinical Research
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Colorado
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Denver, Colorado, United States, 80209
- Downtown Women's Health Care
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Lakewood, Colorado, United States, 80228
- Red Rocks OB/Gyn
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- Women's Health CT Ob/Gyn
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Florida
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North Miami, Florida, United States, 33161
- Segal Institute for Clinical Research
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Plantation, Florida, United States, 33324
- Discovery Clinical Research
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Georgia
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Augusta, Georgia, United States, 30912
- Georgia Regents University
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Roswell, Georgia, United States, 30075
- Atlanta North Gynecology
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Sandy Springs, Georgia, United States, 30328
- Mount Vernon Clinical Research
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Rosemark Womens Care Specialists
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Illinois
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Champaign, Illinois, United States, 61802
- Women's Health Practice
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Michigan
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Kalamazoo, Michigan, United States, 49009
- Women's Healthcare Specialists, PC
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Women's Clinic of Lincoln
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Nevada
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Las Vegas, Nevada, United States, 89123
- Legacy Women's Health
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Las Vegas, Nevada, United States, 89128
- R. Garn Mabey Jr., MD Gynecology
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New Jersey
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Lawrenceville, New Jersey, United States, 08648
- Lawrence Ob/Gyn Clinical Research LLC
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Plainsboro, New Jersey, United States, 08536
- Women's Health Research Center
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New York
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Port Jefferson, New York, United States, 11777
- Suffolk OB/GYN
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North Carolina
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New Bern, North Carolina, United States, 28562
- East Carolina Women's Center
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates
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Ohio
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Columbus, Ohio, United States, 43212
- Radiant Research
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- Drexel University
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Philadelphia, Pennsylvania, United States, 19114
- Philapelphia Clinical Research, LLC
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Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital of UPMC
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South Carolina
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North Charleston, South Carolina, United States, 29406
- James T. Martin, MD
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Tennessee
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Jackson, Tennessee, United States, 38305
- The Jackson Clinic
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Texas
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Houston, Texas, United States, 77054
- TMC Life Research, Inc.
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Seattle, Washington, United States, 98105
- Women's Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metronidazole vaginal gel
One applicator full at bedtime
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|
Placebo Comparator: Gel vehicle
One applicator full at bedtime
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
Time Frame: 7-14 days after beginning treatment
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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
|
7-14 days after beginning treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
Time Frame: 7-14 days after beginning treatment
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Subjects reported if symptoms completely resolved and the date of resolution.
The percentage of participants reporting complete resolution of symptoms was compared between arms.
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7-14 days after beginning treatment
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Number of Participants With Treatment Emergent Adverse Events
Time Frame: Any time during study participation (up to 30 days)
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Adverse events were collected at study visits, from subject diaries and from spontaneous reports
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Any time during study participation (up to 30 days)
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Improvement of BV Clue Cells
Time Frame: 7-14 days after beginning treatment
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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%).
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7-14 days after beginning treatment
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Microbiologic Improvement/Cure
Time Frame: 7-14 days after beginning treatment
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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.
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7-14 days after beginning treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert J Borgman, Ph.D., Curatek Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
December 1, 2014
First Submitted That Met QC Criteria
December 2, 2014
First Posted (Estimate)
December 4, 2014
Study Record Updates
Last Update Posted (Actual)
July 27, 2020
Last Update Submitted That Met QC Criteria
July 9, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTC-001 (Trial 2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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