Multi-Center Study of New Medications to Treat Vaginal Infections (SMART GIVES)

Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety

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

Study Overview

• Status: Completed
• Conditions: Vaginal Infection
• Intervention / Treatment: Drug: Metronidazole; Drug: Terconazole; Drug: Terconazole/metronidazole

• Study Type: Interventional
• Enrollment (Actual): 475
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials, AZ
    • Scottsdale, Arizona, United States, 85251
      • MomDoc Womens Health Research
    • Tucson, Arizona, United States, 85710
      • DelSol Research
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
  • California
    • La Mesa, California, United States, 91942
      • Gossmont Center for Clinical Research
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92103
      • Genesis Center for Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80209
      • Downtown Women's Health Care
    • Lakewood, Colorado, United States, 80228
      • Red Rocks OB/Gyn
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Women's Health CT Ob/Gyn
  • Florida
    • Coral Springs, Florida, United States, 33065
      • Precision Clinical Research
    • Fort Lauderdale, Florida, United States, 33316
      • KO Clinical Research, LLC
    • North Miami, Florida, United States, 33161
      • Segal Institute for Clinical Research
    • Plantation, Florida, United States, 33324
      • Discovery Clinical Research
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials, Llc
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
    • Roswell, Georgia, United States, 30075
      • Atlanta North Gynecology
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rosemark Womens Care Specialists
  • Illinois
    • Champaign, Illinois, United States, 61802
      • Women's Health Practice
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Praetorian Pharmaceutical Research, LLC
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates
    • New Orleans, Louisiana, United States, 70125
      • Women Under Study
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
    • Kalamazoo, Michigan, United States, 49009
      • Women's Healthcare Specialists, PC
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Legacy Women's Health
    • Las Vegas, Nevada, United States, 89128
      • R. Garn Mabey Jr., MD Gynecology
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence Ob/Gyn Clinical Research LLC
    • Plainsboro, New Jersey, United States, 08536
      • Women's Health Research Center
  • New York
    • Port Jefferson, New York, United States, 11777
      • Suffolk OB/GYN
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • East Carolina Women's Center
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Radiant Research
    • Columbus, Ohio, United States, 43231
      • Complete Healthcare For Women
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University
    • Philadelphia, Pennsylvania, United States, 19114
      • Philapelphia Clinical Research, LLC
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Magnolia Ob/Gyn Research Center
    • North Charleston, South Carolina, United States, 29406
      • James T. Martin, MD
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
  • Texas
    • Dallas, Texas, United States, 75231
      • Discovery Clinical Trials
    • Fort Worth, Texas, United States, 76104
      • Signature Gyn Services
    • Houston, Texas, United States, 77054
      • TMC Life Research, Inc.
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital for Women
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98105
      • Women's Clinical Research Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Terconazole vaginal gel; One applicator full at bedtime	Drug: Terconazole
Active Comparator: Metronidazole vaginal gel; One applicator full at bedtime	Drug: Metronidazole
Active Comparator: Terconazole/metronidazole vaginal gel; One applicator full at bedtime	Drug: Terconazole/metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit	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	7-14 days after beginning treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure of the BV Component of Mixed Infection	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	7-14 days after beginning treatment
Cure of the VVC Component of Mixed Infection	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	7-14 days after beginning treatment
Microbiologic and Mycologic Cure	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.	7-14 days after beginning treatment
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit	Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.	7-14 days after beginning treatment
Number of Participants With Treatment Emergent Adverse Events	Adverse events were collected at study visits, from subject diaries and from spontaneous reports	Any time during study participation (up to 30 days)

Collaborators and Investigators

• Sponsor: Curatek Pharmaceuticals, LLC
• Investigators: Study Director: Robert J Borgman, Ph.D., Curatek Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

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): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents; Anti-Bacterial Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Terconazole
• Other Study ID Numbers: MTC-001 (Trial 3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No