Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis.
1 other identifier
interventional
637
6 countries
30
Brief Summary
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedStudy Start
First participant enrolled
October 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2016
CompletedJune 25, 2018
June 1, 2018
1.8 years
September 5, 2014
June 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings
Number of participants with a recurrence
At or by the Week 16 visit
Secondary Outcomes (8)
Time to recurrence of BV according to the primary efficacy endpoint definition
At or by the Week 28 visit
Presence of patient-reported BV symptoms
At or by the Week 16 visit
Recurrence of individual Amsel criteria
At or by the Week 16 visit
Recurrence of BV as determined by presence of a Nugent score of 7-10
At or by the Week 16 visit
Recurrence of BV according to the primary efficacy endpoint definition
At or by the Week 20, 24 and 28 visits
- +3 more secondary outcomes
Study Arms (2)
1% SPL7013 Gel
EXPERIMENTALInserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Placebo Gel
PLACEBO COMPARATORInserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Interventions
One tablet taken orally twice daily for seven consecutive days
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Eligibility Criteria
You may qualify if:
- Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)
- History of recurrent BV (at least 3 episodes in previous year including current episode)
- Using an effective method of contraception
You may not qualify if:
- Test positive for a sexually transmitted infection
- Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
- Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Precision Trials, LLC
Phoenix, Arizona, 85032, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Southern Clinical Research Associates
Metairie, Louisiana, 70001, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Sites Various
Pleven, Bulgaria
Sites Various
Plovidiv, Bulgaria
Sites Various
Sofia, Bulgaria
Sites Various
Stara Zagora, Bulgaria
Sites Various
Brno, Czechia
Sites Various
České Budějovice, Czechia
Sites Various
Olomouc, Czechia
Sites Various
Písek, Czechia
Sites Various
Prague, Czechia
Sites Various
Vsetín, Czechia
Sites Various
Baja, Hungary
Sites Various
Balatonfüred, Hungary
Sites Various
Budapest, Hungary
Sites Various
Debrecen, Hungary
Sites Various
Gyömrő, Hungary
Sites Various
Komárom, Hungary
Sites Various
Létavértes, Hungary
Sites Various
Zalaegerszeg, Hungary
Sites Various
Ivano-Frankivsk, Ukraine
Sites Various
Kyiv, Ukraine
Sites Various
Zaporizhzhia, Ukraine
Sites Various
Birmingham, United Kingdom
Sites Various
Coventry, United Kingdom
Sites Various
Leeds, United Kingdom
Sites Various
London, United Kingdom
Sites Various
Plymouth, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeremy Paull, PhD.
Starpharma Pty Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2014
First Posted
September 10, 2014
Study Start
October 3, 2014
Primary Completion
July 4, 2016
Study Completion
October 4, 2016
Last Updated
June 25, 2018
Record last verified: 2018-06