A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
NCT ID: NCT01577238
Last Updated: 2019-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2012-03-28
2012-07-20
Brief Summary
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After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).
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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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VivaGel
1% SPL7013 Gel
Vaginal gel, daily for 7 days
HEC Placebo
Placebo
Vaginal gel, daily for 7 days
Interventions
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1% SPL7013 Gel
Vaginal gel, daily for 7 days
Placebo
Vaginal gel, daily for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Post-menarchal females, aged 12 years or more
* Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
* Nugent score of at least 4
* Otherwise healthy, as determined by medical history, physical examination
* normal Pap smear at or documented within 24 months of screening
12 Years
FEMALE
No
Sponsors
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Starpharma Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremy Paull, PhD
Role: STUDY_CHAIR
Starpharma Pty Ltd
Other Identifiers
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SPL7013-015
Identifier Type: -
Identifier Source: org_study_id
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