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.

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: Metronidazole oral tablets 500mg; Drug: 1% SPL7013 Gel; Drug: Placebo gel

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 Type: Interventional
• Enrollment (Actual): 637
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria
    • Sites Various
  • Plovidiv, Bulgaria
    • Sites Various
  • Sofia, Bulgaria
    • Sites Various
  • Stara Zagora, Bulgaria
    • Sites Various
• Czechia
  • Brno, Czechia
    • Sites Various
  • Ceske Budejovice, Czechia
    • Sites Various
  • Olomouc, Czechia
    • Sites Various
  • Pisek, Czechia
    • Sites Various
  • Praha 2, Czechia
    • Sites Various
  • Vsetin, Czechia
    • Sites Various
• Hungary
  • Baja, Hungary
    • Sites Various
  • Balatonfured, Hungary
    • Sites Various
  • Budapest, Hungary
    • Sites Various
  • Debrecen, Hungary
    • Sites Various
  • Gyomro, Hungary
    • Sites Various
  • Komarom, Hungary
    • Sites Various
  • Letavertes, Hungary
    • Sites Various
  • Zalaegerszeg, Hungary
    • Sites Various
• Ukraine
  • Ivano-Frankivsk, Ukraine
    • Sites Various
  • Kyiv, Ukraine
    • Sites Various
  • Zaporizhzhia, Ukraine
    • Sites Various
• United Kingdom
  • Birmingham, United Kingdom
    • Sites Various
  • Coventry, United Kingdom
    • Sites Various
  • Leeds, United Kingdom
    • Sites Various
  • London, United Kingdom
    • Sites Various
  • Plymouth, United Kingdom
    • Sites Various
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials, LLC
  • California
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1% SPL7013 Gel; Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks	Drug: Metronidazole oral tablets 500mg; One tablet taken orally twice daily for seven consecutive days; Drug: 1% SPL7013 Gel; 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.; Other Names: VivaGel; astodimer sodium
Placebo Comparator: Placebo Gel; Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks	Drug: Metronidazole oral tablets 500mg; One tablet taken orally twice daily for seven consecutive days; Drug: Placebo gel; 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recurrence of BV according to the primary efficacy endpoint definition	Time (days)	At or by the Week 28 visit
Presence of patient-reported BV symptoms	Number of participants with symptoms	At or by the Week 16 visit
Recurrence of individual Amsel criteria	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	At or by the Week 16 visit
Recurrence of BV as determined by presence of a Nugent score of 7-10	Number of participants with a recurrence	At or by the Week 16 visit
Recurrence of BV according to the primary efficacy endpoint definition	Number of participants with a recurrence	At or by the Week 20, 24 and 28 visits
Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4	Number of participants with a recurrence	At or by the Week 16 visit
Adverse events (AEs)	Number of participants	Study duration
Responses to Quality of Life (QoL) Questionnaires		Screening to Week 16

Collaborators and Investigators

• Sponsor: Starpharma Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2014
• Primary Completion (Actual): July 4, 2016
• Study Completion (Actual): October 4, 2016

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Recurrence; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: SPL7013-018