Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
NCT ID: NCT01201057
Last Updated: 2019-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2010-08-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.5% SPL7013 Gel
0.5% SPL7013 Gel
Vaginal gel
1.0% SPL7013 Gel
1.0% SPL7013 Gel
Vaginal gel
3.0% SPL7013 Gel
3.0% SPL7013 Gel
Vaginal gel
Placebo Gel
Placebo Gel
Vaginal gel
Interventions
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0.5% SPL7013 Gel
Vaginal gel
1.0% SPL7013 Gel
Vaginal gel
3.0% SPL7013 Gel
Vaginal gel
Placebo Gel
Vaginal gel
Eligibility Criteria
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Inclusion Criteria
* Otherwise healthy
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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Starpharma Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Anne Macek, MD
Role: PRINCIPAL_INVESTIGATOR
contracted to Starpharma Pty Ltd
Locations
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Precision Trials
Phoenix, Arizona, United States
Downtown Women's Health Care
Denver, Colorado, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Bexar Clinical Trials, LLC
Irving, Texas, United States
Tidewater Clinical Research Inc
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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SPL7013-013
Identifier Type: -
Identifier Source: org_study_id
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