NCT01201057 is a Phase 2 clinical trial of 0.5% SPL7013 Gel in Bacterial Vaginosis, sponsored by Starpharma Pty Ltd.

Who is sponsoring NCT01201057?

NCT01201057 is sponsored by Starpharma Pty Ltd.

What drugs are being tested in NCT01201057?

Interventions in NCT01201057: 0.5% SPL7013 Gel, 1.0% SPL7013 Gel, 3.0% SPL7013 Gel, Placebo Gel.

What condition does NCT01201057 study?

NCT01201057 studies Bacterial Vaginosis.

Is NCT01201057 still recruiting?

NCT01201057 is currently completed. Last updated 3 June 2019.

Are results published for NCT01201057?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-06-03 · How we verify

NCT01201057

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

A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis

Completed Phase 2 Results posted Last updated 3 June 2019

What this trial tests

Phase 2 trial testing 0.5% SPL7013 Gel in Bacterial Vaginosis in 132 participants. Completed in 1 May 2011.

Timeline

1 August 2010

Primary endpoint
1 March 2011

1 May 2011

Quick facts

Lead sponsor	Starpharma Pty Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	132
Start date	1 August 2010
Primary completion	1 March 2011
Estimated completion	1 May 2011
Sites	5 locations across United States

Drugs / interventions tested

0.5% SPL7013 Gel — full drug profile →
1.0% SPL7013 Gel — full drug profile →
3.0% SPL7013 Gel — full drug profile →
Placebo Gel

Conditions studied

Bacterial Vaginosis — all drugs for Bacterial Vaginosis →

Sponsor

Starpharma Pty Ltd — full company profile →

Who can join

Adults 18 to 45, female only, with Bacterial Vaginosis. 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 With Clinical Cure as a Measure of Efficacy
Time frame: Day 21-30
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria

Sponsor's own description

The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.

Publications & conference data

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

Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004).
McGowan I, Gomez K, Bruder K, Febo I, et al · · 2011 · cited 92× · PMID 21505316 · DOI 10.1097/qad.0b013e328346bd3e
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
A phase 2, double-blind, multicenter, randomized, placebo-controlled, dose‑ranging study of the efficacy and safety of Astodrimer Gel for the treatment of bacterial vaginosis.
Waldbaum AS, Schwebke JR, Paull JRA, Price CF, et al · · 2020 · cited 15× · PMID 32365097 · DOI 10.1371/journal.pone.0232394

Verify or expand the search:

Other recruiting trials for Bacterial Vaginosis

Currently open trials in the same condition.

NCT07234786 — Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections · NA · recruiting
NCT06458543 — Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age · Phase 4 · recruiting
NCT06263465 — Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis · NA · recruiting
NCT05753813 — Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome · EARLY_PHASE1 · recruiting
NCT06616168 — Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens · Phase 1 · active not recruiting

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 NCT01201057 (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: 3 June 2019

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/NCT01201057.

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