Phase 3
Completed N=251
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
Source: ClinicalTrials.gov NCT01577537 ↗Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Women With Clinical Cure at the End of Treatment Visit (EOT) — 68; 25 Participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 | — |
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. Informational only — not medical advice.