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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Arizona
      • 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
      • 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
    • 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
    • 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
      • Houston, Texas, United States, 77054
        • TMC Life Research, Inc.
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98105
        • Women's Clinical Research Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Metronidazole vaginal gel
One applicator full at bedtime
Drug: Metronidazole
Placebo Comparator: Gel vehicle
One applicator full at bedtime
Drug: Gel vehicle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Time Frame: Any time during study participation (up to 30 days)
Adverse events were collected at study visits, from subject diaries and from spontaneous reports
Any time during study participation (up to 30 days)
Improvement of BV Clue Cells
Time Frame: 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%).
7-14 days after beginning treatment
Microbiologic Improvement/Cure
Time Frame: 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.
7-14 days after beginning treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Curatek Pharmaceuticals, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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