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The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5% SPL7013 Gel | Experimental |
| |
| 1.0% SPL7013 Gel | Experimental |
| |
| 3.0% SPL7013 Gel | Experimental |
| |
| Placebo Gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% SPL7013 Gel | Drug | Vaginal gel |
| |
| 1.0% SPL7013 Gel |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 21-30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 9-12 |
| Number of Women With Nugent Cure as a Measure of Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Macek, MD | contracted to Starpharma Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Precision Trials | Phoenix | Arizona | 85032 | United States | ||
| Downtown Women's Health Care |
No relevant events.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5% SPL7013 Gel | 0.5% SPL7013 Gel: Vaginal gel |
| FG001 | 1.0% SPL7013 Gel | 1.0% SPL7013 Gel: Vaginal gel |
| FG002 | 3.0% SPL7013 Gel | 3.0% SPL7013 Gel: Vaginal gel |
| FG003 | Placebo Gel | Placebo Gel: Vaginal gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
modified intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5% SPL7013 Gel | 0.5% SPL7013 Gel: Vaginal gel |
| BG001 | 1.0% SPL7013 Gel | 1.0% SPL7013 Gel: Vaginal gel |
| 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 as a Measure of Efficacy | Number of women with clinical cure as determined by absence of BV by the Amsel's criteria | The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed. | Posted | Count of Participants | Participants | Day 21-30 |
|
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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 | 0.5% SPL7013 Gel | 0.5% SPL7013 Gel: Vaginal gel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginal pruritus | Reproductive system and breast disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jeremy Paull | Starpharma | jeremy.paull@starpharma.com |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| Drug |
Vaginal gel |
|
| 3.0% SPL7013 Gel | Drug | Vaginal gel |
|
| Placebo Gel | Other | Vaginal gel |
|
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.
| Day 9-30 |
| 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. | Day 9-30 |
| 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. | For the duration of the study (up to Visit Day 21-30) |
| Denver |
| Colorado |
| 80218 |
| United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Bexar Clinical Trials, LLC | Irving | Texas | 75061 | United States |
| Tidewater Clinical Research Inc | Virginia Beach | Virginia | 23456 | United States |
| BG002 |
| 3.0% SPL7013 Gel |
3.0% SPL7013 Gel: Vaginal gel |
| BG003 | Placebo Gel | Placebo Gel: Vaginal gel |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
3.0% SPL7013 Gel: Vaginal gel |
| OG003 | Placebo Gel | Placebo Gel: Vaginal gel |
|
|
|
| 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 | The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed. | Posted | Count of Participants | Participants | Day 9-12 |
|
|
|
|
| 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. | The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed. | Posted | Count of Participants | Participants | Day 9-30 |
|
|
|
|
| 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. | The analysis population is the mITT. | Posted | Count of Participants | Participants | Day 9-30 |
|
|
|
| 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. | This outcome measure is adverse events, which are required to be reported separately under Adverse Events section. | Posted | Count of Participants | Participants | For the duration of the study (up to Visit Day 21-30) |
|
|
|
| 0 |
| 32 |
| 6 |
| 32 |
| EG001 | 1.0% SPL7013 Gel | 1.0% SPL7013 Gel: Vaginal gel | 0 | 32 | 4 | 32 |
| EG002 | 3.0% SPL7013 Gel | 3.0% SPL7013 Gel: Vaginal gel | 0 | 29 | 5 | 29 |
| EG003 | Placebo Gel | Placebo Gel: Vaginal gel | 0 | 32 | 4 | 32 |
| Vulvovaginal burning sensation | Reproductive system and breast disorders |
|
| Vulvovaginal candidiasis | Infections and infestations |
|
| Metrorrhagia | Reproductive system and breast disorders |
|
For a multicenter study, the PIs can only publish after the results of the trial have been 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 |