Recurrent Bacterial Vaginosis (BV)
Conditions
Keywords
BV, Bacterial vaginosis, recurrent, SPL7013 Gel, VivaGel
Brief summary
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
Interventions
Sponsors
Starpharma Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of women who have experienced a recurrent episode of BV as a measure of efficacy | Day 112 +/- 5 | Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria |
Outcome results
None listed