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

Phase 2

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: 3.0% SPL7013 Gel; Drug: 0.5% SPL7013 Gel; Drug: 1.0% SPL7013 Gel; Other: Placebo Gel

• Registration Number: NCT01201057
• Lead Sponsor: Starpharma Pty Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-09-12
• Study First Posted: 2010-09-14
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Disposition First Submitted: 2012-04-18
• Disposition First Submitted QC: 2012-04-18
• Disposition First Posted: 2012-04-19
• Results First Submitted: 2019-04-29
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Results First Posted: 2019-06-06
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3.0% SPL7013 Gel	3.0% SPL7013 Gel	-
0.5% SPL7013 Gel	0.5% SPL7013 Gel	-
1.0% SPL7013 Gel	1.0% SPL7013 Gel	-
Placebo Gel	Placebo Gel	-

Primary Outcome Measures

Name	Time	Method
Number of Women With Clinical Cure as a Measure of Efficacy	Day 21-30	Number of women with clinical cure as determined by absence of BV by the Amsel's criteria

Secondary Outcome Measures

Name	Time	Method
Number of Women With Nugent Cure as a Measure of Efficacy	Day 9-30	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.
Number of Women With Clinical Cure as a Measure of Efficacy	Day 9-12	Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)	Day 9-30	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.
Incidence of Genital Adverse Events Potentially Related to Treatment	For the duration of the study (up to Visit Day 21-30)	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.

Trial Locations

Locations (5)

Precision Trials; 🇺🇸 Phoenix, Arizona, United States

Tidewater Clinical Research Inc; 🇺🇸 Virginia Beach, Virginia, United States

Clinical Research Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Bexar Clinical Trials, LLC; 🇺🇸 Irving, Texas, United States

Downtown Women's Health Care; 🇺🇸 Denver, Colorado, United States