NCT01437722 is a Phase 2 clinical trial of 1% SPL7013 Gel in Recurrent Bacterial Vaginosis (BV), sponsored by Starpharma Pty Ltd.

Who is sponsoring NCT01437722?

NCT01437722 is sponsored by Starpharma Pty Ltd.

What drugs are being tested in NCT01437722?

Interventions in NCT01437722: 1% SPL7013 Gel, 3% SPL7013 Gel, placebo gel.

What condition does NCT01437722 study?

NCT01437722 studies Recurrent Bacterial Vaginosis (BV).

Is NCT01437722 still recruiting?

NCT01437722 is currently completed. Last updated 27 October 2013.

Last reviewed 2013-10-27 · How we verify

NCT01437722

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis

Completed Phase 2 Last updated 27 October 2013

What this trial tests

Phase 2 trial testing 1% SPL7013 Gel in Recurrent Bacterial Vaginosis (BV) in 205 participants. Completed.

Timeline

1 August 2011

Primary endpoint
1 December 2012

Quick facts

Lead sponsor	Starpharma Pty Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	205
Start date	1 August 2011
Primary completion	1 December 2012

Drugs / interventions tested

1% SPL7013 Gel — full drug profile →
3% SPL7013 Gel — full drug profile →
placebo gel

Conditions studied

Recurrent Bacterial Vaginosis (BV) — all drugs for Recurrent Bacterial Vaginosis (BV) →

Sponsor

Starpharma Pty Ltd — full company profile →

Who can join

Adults 18 to 45, female only, with Recurrent Bacterial Vaginosis (BV). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of women who have experienced a recurrent episode of BV as a measure of efficacy
Time frame: Day 112 +/- 5
Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria

Sponsor's own description

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.

Publications & conference data

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

Dendrimers, an Emerging Opportunity in Personalized Medicine?
Caminade AM. · · 2022 · cited 39× · PMID 36013283 · DOI 10.3390/jpm12081334
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

Verify or expand the search:

Other trials of 1% SPL7013 Gel

Trials testing the same drug.

NCT02237950 — Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) · Phase 3 · completed
NCT02236156 — Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) · Phase 3 · completed
NCT01577537 — A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis · Phase 3 · completed
NCT01577238 — A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis · Phase 3 · completed

Other Starpharma Pty Ltd trials

Trials by the same sponsor.

NCT02237950 — Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) · Phase 3 · completed
NCT02236156 — Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) · Phase 3 · completed
NCT01577537 — A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis · Phase 3 · completed
NCT01577238 — A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01437722 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Starpharma Pty Ltd
Last refreshed: 27 October 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01437722.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing