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

Primary Purpose

Vaginal Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Terconazole
Placebo
Sponsored by
Curatek Pharmaceuticals, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Infection

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • New Horizons Clinical Trials
  • MomDoc Womens Health Research
  • NEA Baptist Clinic
  • Gossmont Center for Clinical Research
  • Genesis Center for Clinical Research
  • Medical Center for Clinical Research
  • Downtown Women's Health Care
  • Red Rocks Ob/Gyn
  • Women's Health CT Ob/Gyn
  • KO Clinical Research, LLC
  • Segal Institute for Clinical Research
  • Discovery Clinical Research
  • Georgia Regents University
  • Atlanta North Gynecology
  • Mount Vernon CLinical Research
  • Rosemark Womens Care Specialists
  • Women's Health Practice
  • Praetorian Pharmaceutical Research, LLC
  • Southern Clinical Research Associates
  • Women's Healthcare Specialists, PC
  • Washington University School of Medicine
  • Women's Clinic of Lincoln
  • Legacy Women's Health
  • R. Garn Mabey Jr., MD Gynecology
  • Lawrence Ob/Gyn Clinical Research LLC
  • Women's Health Research Center
  • Suffolk OB/GYN
  • East Carolina Women's Center
  • Wake Research Associates
  • Radiant Research
  • HWC Women's Research Center
  • Drexel University
  • Philapelphia Clinical Research, LLC
  • Magee-Womens Hospital of UPMC
  • James T. Martin, MD
  • The Jackson Clinic
  • Discovery Clinical Trials
  • TMC Life Research, Inc.
  • Multicare Women's Center Covington
  • Women's Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Terconazole vaginal gel

Gel vehicle

Arm Description

One applicator full at bedtime

One applicator full at bedtime

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Number of Participants With Treatment Emergent Adverse Events
Adverse events were collected at study visits, from subject diaries and from spontaneous reports

Full Information

First Posted
December 1, 2014
Last Updated
July 9, 2020
Sponsor
Curatek Pharmaceuticals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02308046
Brief Title
Multi-Center Study of New Medications to Treat Vaginal Infections
Acronym
SMART GIVES
Official Title
Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Curatek Pharmaceuticals, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Terconazole vaginal gel
Arm Type
Active Comparator
Arm Description
One applicator full at bedtime
Arm Title
Gel vehicle
Arm Type
Placebo Comparator
Arm Description
One applicator full at bedtime
Intervention Type
Drug
Intervention Name(s)
Terconazole
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
Description
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
Time Frame
7-14 days after beginning treatment
Secondary Outcome Measure Information:
Title
Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection
Description
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.
Time Frame
7-14 days after beginning treatment
Title
Mycologic Cure
Description
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.
Time Frame
7-14 days after beginning treatment and at 21-30 days after beginning treatment
Title
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
Description
Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.
Time Frame
7-14 days after beginning treatment
Title
Number of Participants With Treatment Emergent Adverse Events
Description
Adverse events were collected at study visits, from subject diaries and from spontaneous reports
Time Frame
Any time during study participation (up to 30 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Borgman, Ph.D.
Organizational Affiliation
Curatek Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
New Horizons Clinical Trials
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
MomDoc Womens Health Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Gossmont Center for Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Red Rocks Ob/Gyn
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Women's Health CT Ob/Gyn
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
KO Clinical Research, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Discovery Clinical Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Atlanta North Gynecology
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Mount Vernon CLinical Research
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Rosemark Womens Care Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Women's Health Practice
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61802
Country
United States
Facility Name
Praetorian Pharmaceutical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Southern Clinical Research Associates
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Women's Healthcare Specialists, PC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Women's Clinic of Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Legacy Women's Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
R. Garn Mabey Jr., MD Gynecology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Lawrence Ob/Gyn Clinical Research LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Women's Health Research Center
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
Facility Name
Suffolk OB/GYN
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
East Carolina Women's Center
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
HWC Women's Research Center
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Philapelphia Clinical Research, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
James T. Martin, MD
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
The Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Discovery Clinical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
TMC Life Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Multicare Women's Center Covington
City
Covington
State/Province
Washington
ZIP/Postal Code
98042
Country
United States
Facility Name
Women's Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multi-Center Study of New Medications to Treat Vaginal Infections

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