Clinical trial NCT02236156: Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Lead sponsor: Starpharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 637
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings
timeFrame: At or by the Week 16 visit
Secondary outcomes:
measure: Time to recurrence of BV according to the primary efficacy endpoint definition
timeFrame: At or by the Week 28 visit
measure: Presence of patient-reported BV symptoms
timeFrame: At or by the Week 16 visit
measure: Recurrence of individual Amsel criteria
timeFrame: At or by the Week 16 visit
measure: Recurrence of BV as determined by presence of a Nugent score of 7-10
timeFrame: At or by the Week 16 visit
measure: Recurrence of BV according to the primary efficacy endpoint definition
timeFrame: At or by the Week 20, 24 and 28 visits
measure: Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4
timeFrame: At or by the Week 16 visit
measure: Adverse events (AEs)
timeFrame: Study duration
measure: Responses to Quality of Life (QoL) Questionnaires
timeFrame: Screening to Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Precision Trials, LLC
state: Arizona
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Metairie
country: United States
facility: Southern Clinical Research Associates
state: Louisiana
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Pleven
country: Bulgaria
facility: Sites Various
city: Plovidiv
country: Bulgaria
facility: Sites Various
city: Sofia
country: Bulgaria
facility: Sites Various
city: Stara Zagora
country: Bulgaria
facility: Sites Various
city: Brno
country: Czechia
facility: Sites Various
city: Ceske Budejovice
country: Czechia
facility: Sites Various
city: Olomouc
country: Czechia
facility: Sites Various
city: Pisek
country: Czechia
facility: Sites Various
city: Praha 2
country: Czechia
facility: Sites Various
city: Vsetin
country: Czechia
facility: Sites Various
city: Baja
country: Hungary
facility: Sites Various
city: Balatonfured
country: Hungary
facility: Sites Various
city: Budapest
country: Hungary
facility: Sites Various
city: Debrecen
country: Hungary
facility: Sites Various
city: Gyomro
country: Hungary
facility: Sites Various
city: Komarom
country: Hungary
facility: Sites Various
city: Letavertes
country: Hungary
facility: Sites Various
city: Zalaegerszeg
country: Hungary
facility: Sites Various
city: Ivano-Frankivsk
country: Ukraine
facility: Sites Various
city: Kyiv
country: Ukraine
facility: Sites Various
city: Zaporizhzhia
country: Ukraine
facility: Sites Various
city: Birmingham
country: United Kingdom
facility: Sites Various
city: Coventry
country: United Kingdom
facility: Sites Various
city: Leeds
country: United Kingdom
facility: Sites Various
city: London
country: United Kingdom
facility: Sites Various
city: Plymouth
country: United Kingdom
facility: Sites Various
Study officials:
affiliation: Starpharma Pty Ltd
name: Jeremy Paull, PhD.
role: STUDY_CHAIR
References: