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 gel in the treatment of vaginal infections

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Arizona
    • Chandler, Arizona, United States, 85224
      • New Horizons Clinical Trials
    • Scottsdale, Arizona, United States, 85251
      • MomDoc Womens Health 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
    • 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
  • 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
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Praetorian Pharmaceutical Research, LLC
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates
  • Michigan
    • 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
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center
  • 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
    • 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
    • Houston, Texas, United States, 77054
      • TMC Life Research, Inc.
  • Washington
    • Covington, Washington, United States, 98042
      • Multicare Women's Center Covington
    • 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Terconazole vaginal gel; One applicator full at bedtime	Drug: Terconazole
Placebo Comparator: Gel vehicle; One applicator full at bedtime	Drug: Placebo

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	The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the 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
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)
Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection	Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement.	7-14 days after beginning treatment
Mycologic Cure	Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure.	7-14 days after beginning treatment and at 21-30 days after beginning treatment

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 (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: Infections; Anti-Infective Agents; Antifungal Agents; Terconazole
• Other Study ID Numbers: MTC-001 (Trial 1)

Plan for Individual participant data (IPD)

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