Bacterial Vaginosis
Conditions
Keywords
SPL7013, VivaGel, bacterial vaginosis, BV
Brief summary
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
Interventions
DRUG0.5% SPL7013 Gel
Vaginal gel
DRUG1.0% SPL7013 Gel
Vaginal gel
DRUG3.0% SPL7013 Gel
Vaginal gel
OTHERPlacebo Gel
Vaginal gel
Sponsors
Starpharma Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4 * Otherwise healthy
Exclusion criteria
* No active STIs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women With Clinical Cure as a Measure of Efficacy | Day 21-30 | Number of women with clinical cure as determined by absence of BV by the Amsel's criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women With Clinical Cure as a Measure of Efficacy | Day 9-12 | Number of women with clinical cure as determined by absence of BV by the Amsel's criteria |
| Number of Women With Nugent Cure as a Measure of Efficacy | Day 9-30 | Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline. |
| Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor) | Day 9-30 | Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor. |
| Incidence of Genital Adverse Events Potentially Related to Treatment | For the duration of the study (up to Visit Day 21-30) | Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety. |
Countries
United States
Participant flow
Pre-assignment details
No relevant events.
Participants by arm
| Arm | Count |
|---|---|
| 0.5% SPL7013 Gel 0.5% SPL7013 Gel: Vaginal gel | 30 |
| 1.0% SPL7013 Gel 1.0% SPL7013 Gel: Vaginal gel | 27 |
| 3.0% SPL7013 Gel 3.0% SPL7013 Gel: Vaginal gel | 26 |
| Placebo Gel Placebo Gel: Vaginal gel | 28 |
| Total | 111 |
Baseline characteristics
| Characteristic | Placebo Gel | Total | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel |
|---|---|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 7.66 | 29.8 years STANDARD_DEVIATION 7.26 | 29.0 years STANDARD_DEVIATION 7.68 | 30.0 years STANDARD_DEVIATION 6.66 | 29.5 years STANDARD_DEVIATION 7.24 |
| Region of Enrollment United States | 28 participants | 111 participants | 30 participants | 27 participants | 26 participants |
| Sex: Female, Male Female | 28 Participants | 111 Participants | 30 Participants | 27 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 32 | 4 / 32 | 5 / 29 | 4 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 29 | 0 / 32 |
Outcome results
Primary
Number of Women With Clinical Cure as a Measure of Efficacy
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Time frame: Day 21-30
Population: The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5% SPL7013 Gel | Number of Women With Clinical Cure as a Measure of Efficacy | 7 Participants |
| 1.0% SPL7013 Gel | Number of Women With Clinical Cure as a Measure of Efficacy | 12 Participants |
| 3.0% SPL7013 Gel | Number of Women With Clinical Cure as a Measure of Efficacy | 7 Participants |
| Placebo Gel | Number of Women With Clinical Cure as a Measure of Efficacy | 3 Participants |
p-value: 0.006Cochran-Mantel-Haenszel
Secondary
Incidence of Genital Adverse Events Potentially Related to Treatment
Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.
Time frame: For the duration of the study (up to Visit Day 21-30)
Population: This outcome measure is adverse events, which are required to be reported separately under Adverse Events section.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5% SPL7013 Gel | Incidence of Genital Adverse Events Potentially Related to Treatment | 6 Participants |
| 1.0% SPL7013 Gel | Incidence of Genital Adverse Events Potentially Related to Treatment | 5 Participants |
| 3.0% SPL7013 Gel | Incidence of Genital Adverse Events Potentially Related to Treatment | 6 Participants |
| Placebo Gel | Incidence of Genital Adverse Events Potentially Related to Treatment | 6 Participants |
Secondary
Number of Women With Clinical Cure as a Measure of Efficacy
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Time frame: Day 9-12
Population: The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5% SPL7013 Gel | Number of Women With Clinical Cure as a Measure of Efficacy | 16 Participants |
| 1.0% SPL7013 Gel | Number of Women With Clinical Cure as a Measure of Efficacy | 20 Participants |
| 3.0% SPL7013 Gel | Number of Women With Clinical Cure as a Measure of Efficacy | 15 Participants |
| Placebo Gel | Number of Women With Clinical Cure as a Measure of Efficacy | 6 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Number of Women With Nugent Cure as a Measure of Efficacy
Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.
Time frame: Day 9-30
Population: The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5% SPL7013 Gel | Number of Women With Nugent Cure as a Measure of Efficacy | 6 Participants |
| 1.0% SPL7013 Gel | Number of Women With Nugent Cure as a Measure of Efficacy | 5 Participants |
| 3.0% SPL7013 Gel | Number of Women With Nugent Cure as a Measure of Efficacy | 6 Participants |
| Placebo Gel | Number of Women With Nugent Cure as a Measure of Efficacy | 0 Participants |
p-value: 0.025Cochran-Mantel-Haenszel
Secondary
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.
Time frame: Day 9-30
Population: The analysis population is the mITT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5% SPL7013 Gel | Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor) | 20 Participants |
| 1.0% SPL7013 Gel | Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor) | 21 Participants |
| 3.0% SPL7013 Gel | Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor) | 21 Participants |
| Placebo Gel | Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor) | 8 Participants |