Phase 2
N=132
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT01201057 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Women With Clinical Cure as a Measure of Efficacy — 7; 12; 7; 3 Participants — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.5% SPL7013 Gel (Drug); 1.0% SPL7013 Gel (Drug); 3.0% SPL7013 Gel (Drug); Placebo Gel (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Starpharma Pty Ltd
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Women With Clinical Cure as a Measure of Efficacy |
16; 20; 15; 6 | <0.001 sig |
| SECONDARY Number of Women With Clinical Cure as a Measure of Efficacy |
16; 20; 15; 6 | <0.001 sig |
| SECONDARY Number of Women With Nugent Cure as a Measure of Efficacy |
6; 5; 6; 0 | 0.025 sig |
| SECONDARY Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor) |
20; 21; 21; 8 | — |
| SECONDARY Incidence of Genital Adverse Events Potentially Related to Treatment |
6; 5; 6; 6 | — |
Summary
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
Eligibility Criteria
Inclusion Criteria
- Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
- Otherwise healthy
Exclusion Criteria
- No active STIs
Data sourced from ClinicalTrials.gov (NCT01201057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.