Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Phase 3

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Metronidazole oral tablets 500mg; Drug: 1% SPL7013 Gel; Drug: Placebo gel

• Registration Number: NCT02236156
• Lead Sponsor: Starpharma Pty Ltd

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.

Detailed Description

Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.

The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.

Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.

Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.

Study Timeline

• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-10
• Study Start: 2014-10-03
• Primary Completion: 2016-07-04
• Study Completion: 2016-10-04
• Disposition First Submitted: 2017-12-04
• Disposition First Submitted QC: 2017-12-04
• Disposition First Posted: 2017-12-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 637

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% SPL7013 Gel	Metronidazole oral tablets 500mg	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
1% SPL7013 Gel	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Placebo Gel	Metronidazole oral tablets 500mg	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
Placebo Gel	Placebo gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks

Primary Outcome Measures

Name	Time	Method
Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings	At or by the Week 16 visit	Number of participants with a recurrence

Secondary Outcome Measures

Name	Time	Method
Responses to Quality of Life (QoL) Questionnaires	Screening to Week 16
Presence of patient-reported BV symptoms	At or by the Week 16 visit	Number of participants with symptoms
Recurrence of BV as determined by presence of a Nugent score of 7-10	At or by the Week 16 visit	Number of participants with a recurrence
Recurrence of BV according to the primary efficacy endpoint definition	At or by the Week 20, 24 and 28 visits	Number of participants with a recurrence
Time to recurrence of BV according to the primary efficacy endpoint definition	At or by the Week 28 visit	Time (days)
Recurrence of individual Amsel criteria	At or by the Week 16 visit	Individual Amsel criteria are: i) Presence of homogenous vaginal discharge characteristic of BV; ii) Positive whiff test; iii) Clue cells representing at least 20% of total epithelial cells; iv) vaginal fluid pH greater than 4.5
Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4	At or by the Week 16 visit	Number of participants with a recurrence
Adverse events (AEs)	Study duration	Number of participants

Trial Locations

Locations (5)

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Sites Various; 🇬🇧 Plymouth, United Kingdom

Precision Trials, LLC; 🇺🇸 Phoenix, Arizona, United States

Southern Clinical Research Associates; 🇺🇸 Metairie, Louisiana, United States

Lyndhurst Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States