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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02308033 |
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Date of registration:
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01/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Multi-Center Study of New Medications to Treat Vaginal Infections
SMART GIVES |
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Scientific title:
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Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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204 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02308033 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert J Borgman, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Curatek Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Vaginal Infection
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Intervention(s)
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Drug: Gel vehicle
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Drug: Metronidazole
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Primary Outcome(s)
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Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
[Time Frame: 7-14 days after beginning treatment]
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Secondary Outcome(s)
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Microbiologic Improvement/Cure
[Time Frame: 7-14 days after beginning treatment]
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Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
[Time Frame: 7-14 days after beginning treatment]
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Improvement of BV Clue Cells
[Time Frame: 7-14 days after beginning treatment]
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Number of Participants With Treatment Emergent Adverse Events
[Time Frame: Any time during study participation (up to 30 days)]
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Secondary ID(s)
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MTC-001 (Trial 2)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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