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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201057
• Other study ID #: SPL7013-013
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: June 2019
• Source: Starpharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• 0.5% SPL7013 Gel
Vaginal gel
• 1.0% SPL7013 Gel
Vaginal gel
• 3.0% SPL7013 Gel
Vaginal gel

Other:
• Placebo Gel
Vaginal gel

Locations

Country	Name	City	State
United States	Downtown Women's Health Care	Denver	Colorado
United States	Bexar Clinical Trials, LLC	Irving	Texas
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Precision Trials	Phoenix	Arizona
United States	Tidewater Clinical Research Inc	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Starpharma Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Women With Clinical Cure as a Measure of Efficacy	Number of women with clinical cure as determined by absence of BV by the Amsel's criteria	Day 21-30
Secondary	Number of Women With Clinical Cure as a Measure of Efficacy	Number of women with clinical cure as determined by absence of BV by the Amsel's criteria	Day 9-12
Secondary	Number of Women With Nugent Cure as a Measure of Efficacy	Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.	Day 9-30
Secondary	Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)	Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.	Day 9-30
Secondary	Incidence of Genital Adverse Events Potentially Related to Treatment	Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.	For the duration of the study (up to Visit Day 21-30)