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

Bacterial Vaginosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236156
• Other study ID #: SPL7013-018
• Status: Completed
• Phase: Phase 3
• Start date: October 3, 2014
• Est. completion date: October 4, 2016

Study information

• Verified date: June 2018
• Source: Starpharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: October 4, 2016
• Est. primary completion date: July 4, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Recurrence
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
• 1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
• Placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Locations

Country	Name	City	State
Bulgaria	Sites Various	Pleven
Bulgaria	Sites Various	Plovidiv
Bulgaria	Sites Various	Sofia
Bulgaria	Sites Various	Stara Zagora
Czechia	Sites Various	Brno
Czechia	Sites Various	Ceske Budejovice
Czechia	Sites Various	Olomouc
Czechia	Sites Various	Pisek
Czechia	Sites Various	Praha 2
Czechia	Sites Various	Vsetin
Hungary	Sites Various	Baja
Hungary	Sites Various	Balatonfured
Hungary	Sites Various	Budapest
Hungary	Sites Various	Debrecen
Hungary	Sites Various	Gyomro
Hungary	Sites Various	Komarom
Hungary	Sites Various	Letavertes
Hungary	Sites Various	Zalaegerszeg
Ukraine	Sites Various	Ivano-Frankivsk
Ukraine	Sites Various	Kyiv
Ukraine	Sites Various	Zaporizhzhia
United Kingdom	Sites Various	Birmingham
United Kingdom	Sites Various	Coventry
United Kingdom	Sites Various	Leeds
United Kingdom	Sites Various	London
United Kingdom	Sites Various	Plymouth
United States	Southern Clinical Research Associates	Metairie	Louisiana
United States	Precision Trials, LLC	Phoenix	Arizona
United States	Medical Center for Clinical Research	San Diego	California
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Starpharma Pty Ltd

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Hungary,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At or by the Week 16 visit
Secondary	Time to recurrence of BV according to the primary efficacy endpoint definition	Time (days)	At or by the Week 28 visit
Secondary	Presence of patient-reported BV symptoms	Number of participants with symptoms	At or by the Week 16 visit
Secondary	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	At or by the Week 16 visit
Secondary	Recurrence of BV as determined by presence of a Nugent score of 7-10	Number of participants with a recurrence	At or by the Week 16 visit
Secondary	Recurrence of BV according to the primary efficacy endpoint definition	Number of participants with a recurrence	At or by the Week 20, 24 and 28 visits
Secondary	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	At or by the Week 16 visit
Secondary	Adverse events (AEs)	Number of participants	Study duration
Secondary	Responses to Quality of Life (QoL) Questionnaires		Screening to Week 16