A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Phase 3

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Placebo; Drug: 1% SPL7013 Gel

• Registration Number: NCT01577238
• Lead Sponsor: Starpharma Pty Ltd

Brief Summary

The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-28
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Primary Completion: 2012-07-20
• Study Completion: 2012-07-20
• Disposition First Submitted: 2012-10-17
• Disposition First Submitted QC: 2012-10-19
• Disposition First Posted: 2012-10-25
• Results First Submitted: 2019-04-29
• Results First Submitted QC: 2019-06-17
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Results First Posted: 2019-07-09
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEC Placebo	Placebo	-
VivaGel	1% SPL7013 Gel	-

Primary Outcome Measures

Name	Time	Method
Number of Women With Clinical Cure at the End of Treatment Visit (EOT)	Day 9-12	Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)

Secondary Outcome Measures

Name	Time	Method
Number of Women With Nugent Cure at the EOT Visit	Day 9-12	Nugent Cure is defined as a Nugent score of 0-3 (normal)
Number of Women With Clinical Cure at the Test of Cure Visit (TOC)	Day 21-30	Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
Adverse Events Potentially Related to Treatment	Screening/baseline through TOC visit, Day 1-30	Number of participants with adverse events considered potentially related to study treatment
Number of Women With Nugent Cure at the TOC Visit	Day 21-30	Nugent Cure is defined as a Nugent score of 0-3 (normal)