Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:August 2011
Contact:Stephanie Edmondson, PhD
Email:stephanie.edmondson@starpharma.com
Phone:+ 61 3 8532 2716

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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


The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the
prevention of recurrence of bacterial vaginosis.


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.
We found this trial at
10
sites
Boynton Beach, Florida 33472
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5920 Saratoga Blvd
Corpus Christi, Texas 78414
361-906-9178
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Corpus Christi, TX
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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San Antonio, TX
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Columbus, Ohio 43231
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Columbus, OH
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Fall River, Massachusetts 02720
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Fall River, MA
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Irving, Texas 75062
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Irving, TX
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Nashville, Tennessee 37203
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Nashville, TN
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Saginaw, MI
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San Luis Obispo, CA
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West Hartford, Connecticut 06117
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West Hartford, CT
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