NCT02236156

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Starpharma Pty Ltd · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
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.
DRUG	Placebo gel	5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Timeline

• Start date: 2014-10-03
• Primary completion: 2016-07-04
• Completion: 2016-10-04
• First posted: 2014-09-10
• Last updated: 2018-06-25

Locations

30 sites across 6 countries: United States, Bulgaria, Czechia, Hungary, Ukraine, United Kingdom