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 |
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials