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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VivaGel | Experimental |
| |
| HEC Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% SPL7013 Gel | Drug | Vaginal gel, daily for 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 9-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Women With Nugent Cure at the EOT Visit | Nugent Cure is defined as a Nugent score of 0-3 (normal) | Day 9-12 |
| 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) |
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Key eligibility criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Paull, PhD | Starpharma Pty Ltd | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | VivaGel | 1% SPL7013 Gel: Vaginal gel, daily for 7 days |
| FG001 | HEC Placebo | Placebo: Vaginal gel, daily for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
modified intent-to-treat (mITT) population, which included all participants in the Safety population who had a Nugent score of 4-10 at Baseline, but excluded those with a Nugent score of 0-3.
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| ID | Title | Description |
|---|---|---|
| BG000 | VivaGel | 1% SPL7013 Gel: Vaginal gel, daily for 7 days |
| BG001 | HEC Placebo | Placebo: Vaginal gel, daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | mITT | Posted | Count of Participants | Participants | Day 9-12 |
|
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Analysis of all participants who received (were dispensed) the study medication, excluding any participants who returned all the study medication unused (Safety population). This population is broader than the modified intent-to-treat population, which included all participants in the Safety population who had a Nugent score of 4-10 at Baseline, but excluded those with a Nugent score of 0-3.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VivaGel | 1% SPL7013 Gel: Vaginal gel, daily for 7 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jeremy Paull | Starpharma | jeremy.paull@starpharma.com |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| C480351 | astodrimer |
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| Placebo | Drug | Vaginal gel, daily for 7 days |
|
| Day 21-30 |
| Number of Women With Nugent Cure at the TOC Visit | Nugent Cure is defined as a Nugent score of 0-3 (normal) | Day 21-30 |
| Adverse Events Potentially Related to Treatment | Number of participants with adverse events considered potentially related to study treatment | Screening/baseline through TOC visit, Day 1-30 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Women With Nugent Cure at the EOT Visit | Nugent Cure is defined as a Nugent score of 0-3 (normal) | mITT | Posted | Count of Participants | Participants | Day 9-12 |
|
|
|
| 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) | mITT | Posted | Count of Participants | Participants | Day 21-30 |
|
|
|
| Secondary | Number of Women With Nugent Cure at the TOC Visit | Nugent Cure is defined as a Nugent score of 0-3 (normal) | mITT | Posted | Count of Participants | Participants | Day 21-30 |
|
|
|
| Secondary | Adverse Events Potentially Related to Treatment | Number of participants with adverse events considered potentially related to study treatment | 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. | Posted | Count of Participants | Participants | Screening/baseline through TOC visit, Day 1-30 |
|
|
|
| 1 |
| 126 |
| 0 |
| 126 |
| EG001 | HEC Placebo | Placebo: Vaginal gel, daily for 7 days | 0 | 121 | 0 | 121 |
For multicenter trials, PIs can publish only after the data from all sites are published collectively.
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |