Overview

This trial is active, not recruiting.

Condition bacterial vaginosis
Treatments metronidazole oral tablets 500mg, 1% spl7013 gel, placebo gel
Phase phase 3
Sponsor Starpharma Pty Ltd
Start date September 2014
End date January 2017
Trial size 620 participants
Trial identifier NCT02236156, SPL7013-018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
1% spl7013 gel VivaGel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
(Placebo Comparator)
Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks
metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Primary Outcomes

Measure
Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings
time frame: At or by the Week 16 visit

Secondary Outcomes

Measure
Time to recurrence of BV according to the primary efficacy endpoint definition
time frame: At or by the Week 28 visit
Presence of patient-reported BV symptoms
time frame: At or by the Week 16 visit
Recurrence of individual Amsel criteria
time frame: At or by the Week 16 visit
Recurrence of BV as determined by presence of a Nugent score of 7-10
time frame: At or by the Week 16 visit
Recurrence of BV according to the primary efficacy endpoint definition
time frame: 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
time frame: At or by the Week 16 visit
Adverse events (AEs)
time frame: Study duration
Responses to Quality of Life (QoL) Questionnaires
time frame: Screening to Week 16

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title 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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Starpharma Pty Ltd.