A Phase 2 interventional study of 0.5% SPL7013 Gel and 1.0% SPL7013 Gel in Bacterial Vaginosis, sponsored by Starpharma Pty Ltd. Completed at 5 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by Starpharma Pty Ltd · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 132 is above the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Starpharma Pty Ltd is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 0.5% SPL7013 Gel
Drug: 1.0% SPL7013 Gel
Drug: 3.0% SPL7013 Gel
Other: Placebo Gel
Vaginal gel
Vaginal gel
Vaginal gel
Vaginal gel
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
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
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
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
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)
| Milestone | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel |
|---|---|---|---|---|
| Started | 34 | 33 | 32 | 33 |
| Completed | 32 | 29 | 27 | 29 |
| Not completed | 2 | 4 | 5 | 4 |
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
| Participants | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel |
|---|---|---|---|---|
| Number of Women With Clinical Cure as a Measure of Efficacy | 7 | 12 | 7 | 3 |
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
| Participants | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel |
|---|---|---|---|---|
| Number of Women With Clinical Cure as a Measure of Efficacy | 16 | 20 | 15 | 6 |
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.
| Participants | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel |
|---|---|---|---|---|
| Number of Women With Nugent Cure as a Measure of Efficacy | 6 | 5 | 6 | 0 |
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.
| Participants | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel |
|---|---|---|---|---|
| Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor) | 20 | 21 | 21 | 8 |
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.
| Participants | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel |
|---|---|---|---|---|
| Incidence of Genital Adverse Events Potentially Related to Treatment | 6 | 5 | 6 | 6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.5% SPL7013 Gel | — | 0/32 (0%) | 6/32 (18.8%) |
| 1.0% SPL7013 Gel | — | 0/32 (0%) | 4/32 (12.5%) |
| 3.0% SPL7013 Gel | — | 0/29 (0%) | 5/29 (17.2%) |
| Placebo Gel | — | 0/32 (0%) | 4/32 (12.5%) |
| Event | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel |
|---|---|---|---|---|
| Vulvovaginal pruritusReproductive system and breast disorders | 4/32 | 2/32 | 2/29 | 4/32 |
| Vulvovaginal candidiasisInfections and infestations | 1/32 | 1/32 | 3/29 | 1/32 |
| Vulvovaginal burning sensationReproductive system and breast disorders | 1/32 | 2/32 | 2/29 | 0/32 |
| MetrorrhagiaReproductive system and breast disorders | 2/32 | 0/32 | 0/29 | 0/32 |
modified intent-to-treat population
| Age, Continuous(years) | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel | Total |
|---|---|---|---|---|---|
| Mean | 29.0 ± 7.68 | 30.0 ± 6.66 | 29.5 ± 7.24 | 30.6 ± 7.66 | 29.8 ± 7.26 |
| Sex: Female, Male(Participants) | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel | Total |
|---|---|---|---|---|---|
| Female | 30 | 27 | 26 | 28 | 111 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | 0.5% SPL7013 Gel | 1.0% SPL7013 Gel | 3.0% SPL7013 Gel | Placebo Gel | Total |
|---|---|---|---|---|---|
| United States | 30 | 27 | 26 | 28 | 111 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Starpharma Pty Ltd