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

Starpharma

Status and phase: Completed; Phase 3

Conditions: Bacterial Vaginosis

Treatments: Drug: Metronidazole oral tablets 500mg; Drug: Placebo gel; Drug: 1% SPL7013 Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02236156

SPL7013-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 637 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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637 participants in 2 patient groups, including a placebo group

1% SPL7013 Gel

Experimental group

Description:

Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks

Treatment:

Drug: 1% SPL7013 Gel

Drug: Metronidazole oral tablets 500mg

Placebo Gel

Placebo Comparator group

Description:

Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks

Treatment:

Drug: Metronidazole oral tablets 500mg

Drug: Placebo gel