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

Starpharma Pty Ltd637 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

637

Conditions

Bacterial Vaginosis

Interventions

Metronidazole oral tablets 500mgDRUG

One tablet taken orally twice daily for seven consecutive days

1% SPL7013 GelDRUG

5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.

Placebo gelDRUG

5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (30)

Precision Trials, LLC

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: At or by the Week 16 visit

Secondary Outcomes

Time to recurrence of BV according to the primary efficacy endpoint definition

Time (days)

Time frame: At or by the Week 28 visit

Presence of patient-reported BV symptoms

Number of participants with symptoms

Time frame: 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

Time frame: 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

Time frame: At or by the Week 16 visit

Recurrence of BV according to the primary efficacy endpoint definition

Number of participants with a recurrence

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

Number of participants with a recurrence

Time frame: At or by the Week 16 visit

Data from ClinicalTrials.gov

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