Phase 3
N=251
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT01577537 ↗Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) — 68; 25 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 1% SPL7013 Gel (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Starpharma Pty Ltd
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Women With Clinical Cure at the End of Treatment Visit (EOT) |
68; 25 | <0.001 sig |
| SECONDARY Number of Women With Nugent Cure at the EOT Visit |
16; 6 | — |
| SECONDARY Number of Women With Clinical Cure at the Test of Cure Visit (TOC) |
34; 33 | — |
| SECONDARY Number of Women With Nugent Cure at the TOC Visit |
16; 13 | — |
| SECONDARY Adverse Events Potentially Related to Treatment |
17; 9 | — |
Summary
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).
After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).
Eligibility Criteria
Key eligibility criteria:
- Post-menarchal females, aged 12 years or more
- Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
- Nugent score of at least 4
- Otherwise healthy, as determined by medical history, physical examination
- normal Pap smear at or documented within 24 months of screening
Data sourced from ClinicalTrials.gov (NCT01577537). 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.