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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02308007
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Curatek Pharmaceuticals, LLC

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

Condition or disease Intervention/treatment Phase
Vaginal Infection Drug: Terconazole Drug: Metronidazole Drug: Terconazole/metronidazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
Study Start Date : June 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Cure of Mixed Infection (BV and VVC) 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 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


Secondary Outcome Measures :
  1. Cure of the BV Component of Mixed Infection [ Time Frame: 7-14 days after beginning treatment ]
    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

  2. Cure of the VVC Component of Mixed Infection [ Time Frame: 7-14 days after beginning treatment ]
    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

  3. Microbiologic and Mycologic Cure [ Time Frame: 7-14 days after beginning treatment ]
    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.

  4. 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.

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308007


Locations
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Sponsors and Collaborators
Curatek Pharmaceuticals, LLC
Investigators
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Study Director: Robert J Borgman, Ph.D. Curatek Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Curatek Pharmaceuticals, LLC:
Study Protocol  [PDF] March 12, 2015
Statistical Analysis Plan  [PDF] May 1, 2018

More Information
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Responsible Party: Curatek Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT02308007    
Other Study ID Numbers: MTC-001 (Trial 3)
First Posted: December 4, 2014    Key Record Dates
Results First Posted: August 4, 2020
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infections
Metronidazole
Terconazole
Anti-Infective Agents
 Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents