Bacterial Vaginosis
Conditions
Keywords
SPL7013, VivaGel, bacterial vaginosis, BV
Brief summary
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV). After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).
Interventions
DRUG1% SPL7013 Gel
Vaginal gel, daily for 7 days
DRUGPlacebo
Vaginal gel, daily for 7 days
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
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key eligibility criteria: * Post-menarchal females, aged 12 years or more * Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells * Nugent score of at least 4 * Otherwise healthy, as determined by medical history, physical examination * normal Pap smear at or documented within 24 months of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women With Clinical Cure at the End of Treatment Visit (EOT) | Day 9-12 | Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women With Nugent Cure at the EOT Visit | Day 9-12 | Nugent Cure is defined as a Nugent score of 0-3 (normal) |
| Number of Women With Clinical Cure at the Test of Cure Visit (TOC) | Day 21-30 | Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1) |
| Number of Women With Nugent Cure at the TOC Visit | Day 21-30 | Nugent Cure is defined as a Nugent score of 0-3 (normal) |
| Adverse Events Potentially Related to Treatment | Screening/baseline through TOC visit, Day 1-30 | Number of participants with adverse events considered potentially related to study treatment |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VivaGel 1% SPL7013 Gel: Vaginal gel, daily for 7 days | 117 |
| HEC Placebo Placebo: Vaginal gel, daily for 7 days | 115 |
| Total | 232 |
Baseline characteristics
| Characteristic | VivaGel | HEC Placebo | Total |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 10 | 32.9 years STANDARD_DEVIATION 9.7 | 32.6 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 117 participants | 115 participants | 232 participants |
| Sex: Female, Male Female | 117 Participants | 115 Participants | 232 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 126 | 0 / 121 |
| serious Total, serious adverse events | 1 / 126 | 0 / 121 |
Outcome results
Primary
Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
Time frame: Day 9-12
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VivaGel | Number of Women With Clinical Cure at the End of Treatment Visit (EOT) | 59 Participants |
| HEC Placebo | Number of Women With Clinical Cure at the End of Treatment Visit (EOT) | 19 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Adverse Events Potentially Related to Treatment
Number of participants with adverse events considered potentially related to study treatment
Time frame: Screening/baseline through TOC visit, Day 1-30
Population: Safety population. One participant of those randomized to the 1% SPL7013 Gel was lost to follow-up, and two participants of those randomized to Placebo did not use study medication, and therefore were not included in the Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VivaGel | Adverse Events Potentially Related to Treatment | 20 Participants |
| HEC Placebo | Adverse Events Potentially Related to Treatment | 14 Participants |
Secondary
Number of Women With Clinical Cure at the Test of Cure Visit (TOC)
Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
Time frame: Day 21-30
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VivaGel | Number of Women With Clinical Cure at the Test of Cure Visit (TOC) | 31 Participants |
| HEC Placebo | Number of Women With Clinical Cure at the Test of Cure Visit (TOC) | 24 Participants |
Secondary
Number of Women With Nugent Cure at the EOT Visit
Nugent Cure is defined as a Nugent score of 0-3 (normal)
Time frame: Day 9-12
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VivaGel | Number of Women With Nugent Cure at the EOT Visit | 15 Participants |
| HEC Placebo | Number of Women With Nugent Cure at the EOT Visit | 3 Participants |
Secondary
Number of Women With Nugent Cure at the TOC Visit
Nugent Cure is defined as a Nugent score of 0-3 (normal)
Time frame: Day 21-30
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VivaGel | Number of Women With Nugent Cure at the TOC Visit | 11 Participants |
| HEC Placebo | Number of Women With Nugent Cure at the TOC Visit | 5 Participants |