Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT01201057
First received: August 30, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Bacterial Vaginosis
Drug: 0.5% SPL7013 Gel
Drug: 1.0% SPL7013 Gel
Drug: 3.0% SPL7013 Gel
Other: Placebo Gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Starpharma Pty Ltd:

Primary Outcome Measures:
  • Number of women with clinical cure as a measure of efficacy [ Time Frame: Day 21-30 ] [ Designated as safety issue: No ]
    Number of women with clinical cure as determined by absence of BV by the Amsel's criteria


Secondary Outcome Measures:
  • Number of women with clinical cure as a measure of efficacy [ Time Frame: Day 9-12 ] [ Designated as safety issue: No ]
    Number of women with clinical cure as determined by absence of BV by the Amsel's criteria

  • Number of women with Nugent cure as a measure of efficacy [ Time Frame: Day 9-30 ] [ Designated as safety issue: No ]
    Number of women with Nugent cure as determined by absence of BV by the Nugent score

  • Patient perceived symptom resolution as a measure of efficacy [ Time Frame: Day 9-30 ] [ Designated as safety issue: No ]
    Number of women with absence of perceived symptoms as determined by a symptom questionnaire

  • Number of women who experience genital and other adverse events as a measure of safety [ Time Frame: For the duration of the study (up to Visit Day 21-30) ] [ Designated as safety issue: Yes ]
    Incidence of signs/symptoms of genital irritation by solicited reporting of specific AEs, and incidence of all other AEs reported by women during the study.


Enrollment: 132
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5% SPL7013 Gel Drug: 0.5% SPL7013 Gel
Vaginal gel
Experimental: 1.0% SPL7013 Gel Drug: 1.0% SPL7013 Gel
Vaginal gel
Experimental: 3.0% SPL7013 Gel Drug: 3.0% SPL7013 Gel
Vaginal gel
Placebo Comparator: Placebo Gel Other: Placebo Gel
Vaginal gel

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
  • Otherwise healthy

Exclusion Criteria:

  • No active STIs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201057

Locations
United States, Arizona
Precision Trials
Phoenix, Arizona, United States, 85032
United States, Colorado
Downtown Women's Health Care
Denver, Colorado, United States, 80218
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, Texas
Bexar Clinical Trials, LLC
Irving, Texas, United States, 75061
United States, Virginia
Tidewater Clinical Research Inc
Virginia Beach, Virginia, United States, 23456
Sponsors and Collaborators
Starpharma Pty Ltd
Investigators
Principal Investigator: Anne Macek, MD contracted to Starpharma Pty Ltd
  More Information

No publications provided

Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov Identifier: NCT01201057     History of Changes
Other Study ID Numbers: SPL7013-013
Study First Received: August 30, 2010
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Starpharma Pty Ltd:
SPL7013
VivaGel
bacterial vaginosis
BV

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

ClinicalTrials.gov processed this record on July 20, 2014