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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT01577238
First received: April 12, 2012
Last updated: October 27, 2013
Last verified: October 2013

April 12, 2012
October 27, 2013
March 2012
December 2012   (final data collection date for primary outcome measure)
Number of women with Clinical Cure at the Test of Cure visit (TOC) [ Time Frame: Day 21-30 ] [ Designated as safety issue: No ]
Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
Same as current
Complete list of historical versions of study NCT01577238 on ClinicalTrials.gov Archive Site
  • Number of women with Clinical Cure at the End of Treatment visit (EOT) [ Time Frame: Day 9-12 ] [ Designated as safety issue: No ]
  • Number of women with Nugent Cure at the TOC visit [ Time Frame: Day 21-30 ] [ Designated as safety issue: No ]
    Nugent Cure is defined as a score of 0-3
  • Number of women with Nugent Cure at the EOT visit [ Time Frame: Day 9-12 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Screening - TOC ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Vaginosis
  • Drug: 1% SPL7013 Gel
    Vaginal gel, daily for 7 days
    Other Name: VivaGel
  • Drug: Placebo
    Vaginal gel, daily for 7 days
  • Experimental: VivaGel
    Intervention: Drug: 1% SPL7013 Gel
  • Placebo Comparator: HEC Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Female
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01577238
SPL7013-015
Yes
Starpharma Pty Ltd
Starpharma Pty Ltd
Not Provided
Study Chair: Jeremy Paull, PhD Starpharma Pty Ltd
Starpharma Pty Ltd
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP