NCT01577537

A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Completed Phase 3 Results posted Last updated 17 July 2019

What this trial tests

Phase 3 trial testing 1% SPL7013 Gel in Bacterial Vaginosis in 251 participants. Completed in 5 October 2012.

Timeline

17 April 2012

Primary endpoint
5 October 2012

5 October 2012

Quick facts

Lead sponsor	Starpharma Pty Ltd
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	251
Start date	17 April 2012
Primary completion	5 October 2012
Estimated completion	5 October 2012

Drugs / interventions tested

• 1% SPL7013 Gel — full drug profile →
• Placebo

Conditions studied

• Bacterial Vaginosis — all drugs for Bacterial Vaginosis →

Sponsor

Starpharma Pty Ltd — full company profile →

Who can join

12 and older, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Women With Clinical Cure at the End of Treatment Visit (EOT) Primary · Day 9-12

Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

Group	Value	95% CI
VivaGel	68
HEC Placebo	25

Number of Women With Nugent Cure at the EOT Visit Secondary · Day 9-12

Nugent Cure is defined as a Nugent score of 0-3 (normal)

Group	Value	95% CI
VivaGel	16
HEC Placebo	6

Number of Women With Clinical Cure at the Test of Cure Visit (TOC) Secondary · Day 21-30

Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

Group	Value	95% CI
VivaGel	34
HEC Placebo	33

Number of Women With Nugent Cure at the TOC Visit Secondary · Day 21-30

Nugent Cure is defined as a Nugent score of 0-3 (normal)

Group	Value	95% CI
VivaGel	16
HEC Placebo	13

Adverse Events Potentially Related to Treatment Secondary · Screening/baseline through TOC visit, Day 1-30

Number of participants experiencing adverse events considered potentially related to study treatment.

Group	Value	95% CI
VivaGel	17
HEC Placebo	9

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Translation of Nanomedicine.
   Min Y, Caster JM, Eblan MJ, Wang AZ. · · 2015 · cited 495× · PMID 26088284 · DOI 10.1021/acs.chemrev.5b00116
2. Cartilage-penetrating nanocarriers improve delivery and efficacy of growth factor treatment of osteoarthritis.
   Geiger BC, Wang S, Padera RF, Grodzinsky AJ, et al · · 2018 · cited 212× · PMID 30487252 · DOI 10.1126/scitranslmed.aat8800
3. Dendrimers, an Emerging Opportunity in Personalized Medicine?
   Caminade AM. · · 2022 · cited 39× · PMID 36013283 · DOI 10.3390/jpm12081334
4. Recent advances in targeted drug delivery approaches using dendritic polymers.
   Bugno J, Hsu HJ, Hong S. · · 2015 · cited 31× · PMID 26221937 · DOI 10.1039/c4bm00351a
5. Dendrimer-Mediated Delivery of DNA and RNA Vaccines.
   Kisakova LA, Apartsin EK, Nizolenko LF, Karpenko LI. · · 2023 · cited 29× · PMID 37111593 · DOI 10.3390/pharmaceutics15041106
6. Dendrimers and Dendritic Materials: From Laboratory to Medical Practice in Infectious Diseases.
   Ortega MÁ, Guzmán Merino A, Fraile-Martínez O, Recio-Ruiz J, et al · · 2020 · cited 27× · PMID 32937793 · DOI 10.3390/pharmaceutics12090874
7. Peptides to Overcome the Limitations of Current Anticancer and Antimicrobial Nanotherapies.
   Del Genio V, Bellavita R, Falanga A, Hervé-Aubert K, et al · · 2022 · cited 18× · PMID 35745807 · DOI 10.3390/pharmaceutics14061235
8. Polyethylene glycol-based hydrogels for controlled release of the antimicrobial subtilosin for prophylaxis of bacterial vaginosis.
   Sundara Rajan S, Cavera VL, Zhang X, Singh Y, et al · · 2014 · cited 17× · PMID 24566190 · DOI 10.1128/aac.02446-14