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

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ClinicalTrials.gov Identifier: NCT01437722
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : November 20, 2013
Sponsor:
Information provided by (Responsible Party):
Starpharma Pty Ltd

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

Condition or disease Intervention/treatment Phase
Recurrent Bacterial Vaginosis (BV) Drug: 1% SPL7013 Gel Drug: 3% SPL7013 Gel Drug: placebo gel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : August 2011
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: 1% SPL7013 Gel Drug: 1% SPL7013 Gel
vaginal gel

Experimental: 3% SPL7013 Gel Drug: 3% SPL7013 Gel
vaginal gel

Placebo Comparator: placebo gel Drug: placebo gel
vaginal gel




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437722


Sponsors and Collaborators
Starpharma Pty Ltd
Investigators
Study Director: Jeremy Paull, PhD Starpharma Pty Ltd

Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov Identifier: NCT01437722     History of Changes
Other Study ID Numbers: SPL7013-014
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: October 2013

Keywords provided by Starpharma Pty Ltd:
BV
Bacterial vaginosis
recurrent
SPL7013 Gel
VivaGel

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis