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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01437722 |
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Date of registration:
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20/09/2011 |
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Primary sponsor: |
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Public title:
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Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
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Scientific title:
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A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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206 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01437722 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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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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Stephanie Edmondson, PhD |
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Address:
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Telephone:
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+ 61 3 8532 2716 |
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Email:
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stephanie.edmondson@starpharma.com |
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Affiliation:
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Name:
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Stephanie Edmondson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Starpharma Pty Ltd |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women aged 18-45 years with a history of recurrent BV, defined as at least 3
documented episodes in the previous 12 months (including the current episode).
- Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
- Otherwise healthy
Exclusion Criteria:
- No active STIs and/or current UTI
- Previous exposure to SPL7013 Gel
- A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high
grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical
intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous
2 years or in accordance with local treatment guidelines.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Recurrent Bacterial Vaginosis (BV)
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Intervention(s)
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Drug: 1% SPL7013 Gel
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Drug: 3% SPL7013 Gel
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Drug: placebo gel
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Primary Outcome(s)
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Number of women who have experienced a recurrent episode of BV as a measure of efficacy
[Time Frame: Day 112 +/- 5]
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Secondary ID(s)
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SPL7013-014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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