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

NCT02236156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 637

Last updated 2018-06-25

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis

Interventions

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

Sponsors & Collaborators

  • Starpharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Jeremy Paull, PhD. · Starpharma Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-03
Primary Completion
2016-07-04
Completion
2016-10-04

Countries

  • United States
  • Bulgaria
  • Czechia
  • Hungary
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02236156 on ClinicalTrials.gov