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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: NCT02308046
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : July 27, 2020
Last Update Posted : July 27, 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 gel in the treatment of vaginal infections

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 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
Actual Study Start Date : June 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Terconazole

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis


Secondary Outcome Measures :
  1. Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection [ Time Frame: 7-14 days after beginning treatment ]
    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.

  2. Mycologic Cure [ Time Frame: 7-14 days after beginning treatment and at 21-30 days after beginning treatment ]
    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.

  3. 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.

  4. 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): NCT02308046


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: NCT02308046    
Other Study ID Numbers: MTC-001 (Trial 1)
First Posted: December 4, 2014    Key Record Dates
Results First Posted: July 27, 2020
Last Update Posted: July 27, 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
Terconazole
Antifungal Agents
Anti-Infective Agents