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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01201057
Other study ID # SPL7013-013
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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)
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