Bacterial Vaginosis
Conditions
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.
Interventions
One tablet taken orally twice daily for seven consecutive days
DRUG1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
DRUGPlacebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Sponsors
Starpharma Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings | At or by the Week 16 visit | Number of participants with a recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of patient-reported BV symptoms | At or by the Week 16 visit | Number of participants with symptoms |
| Recurrence of individual Amsel criteria | At or by the Week 16 visit | 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 |
| Recurrence of BV as determined by presence of a Nugent score of 7-10 | At or by the Week 16 visit | Number of participants with a recurrence |
| Time to recurrence of BV according to the primary efficacy endpoint definition | At or by the Week 28 visit | Time (days) |
| Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4 | At or by the Week 16 visit | Number of participants with a recurrence |
| Adverse events (AEs) | Study duration | Number of participants |
| Responses to Quality of Life (QoL) Questionnaires | Screening to Week 16 | — |
| Recurrence of BV according to the primary efficacy endpoint definition | At or by the Week 20, 24 and 28 visits | Number of participants with a recurrence |
Countries
Bulgaria, Czechia, Hungary, Ukraine, United Kingdom, United States
Outcome results
None listed