Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT01437722
First received: September 20, 2011
Last updated: October 27, 2013
Last verified: October 2013

September 20, 2011
October 27, 2013
August 2011
December 2012   (final data collection date for primary outcome measure)
Number of women who have experienced a recurrent episode of BV as a measure of efficacy [ Time Frame: Day 112 +/- 5 ] [ Designated as safety issue: No ]
Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
Same as current
Complete list of historical versions of study NCT01437722 on ClinicalTrials.gov Archive Site
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Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Recurrent Bacterial Vaginosis (BV)
  • Drug: 1% SPL7013 Gel
    vaginal gel
  • Drug: 3% SPL7013 Gel
    vaginal gel
  • Drug: placebo gel
    vaginal gel
  • Experimental: 1% SPL7013 Gel
    Intervention: Drug: 1% SPL7013 Gel
  • Experimental: 3% SPL7013 Gel
    Intervention: Drug: 3% SPL7013 Gel
  • Placebo Comparator: placebo gel
    Intervention: Drug: placebo gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
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December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
  • Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
  • Otherwise healthy

Exclusion Criteria:

  • No active STIs and/or current UTI
  • Previous exposure to SPL7013 Gel
  • A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01437722
SPL7013-014
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Starpharma Pty Ltd
Starpharma Pty Ltd
Not Provided
Study Director: 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