Trial Outcomes & Findings for Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV) (NCT NCT01201057)
NCT ID: NCT01201057
Last Updated: 2019-06-06
Results Overview
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
COMPLETED
PHASE2
132 participants
Day 21-30
2019-06-06
Participant Flow
No relevant events.
Participant milestones
| Measure |
0.5% SPL7013 Gel
0.5% SPL7013 Gel: Vaginal gel
|
1.0% SPL7013 Gel
1.0% SPL7013 Gel: Vaginal gel
|
3.0% SPL7013 Gel
3.0% SPL7013 Gel: Vaginal gel
|
Placebo Gel
Placebo Gel: Vaginal gel
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
32
|
33
|
|
Overall Study
COMPLETED
|
32
|
29
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
Baseline characteristics by cohort
| Measure |
0.5% SPL7013 Gel
n=30 Participants
0.5% SPL7013 Gel: Vaginal gel
|
1.0% SPL7013 Gel
n=27 Participants
1.0% SPL7013 Gel: Vaginal gel
|
3.0% SPL7013 Gel
n=26 Participants
3.0% SPL7013 Gel: Vaginal gel
|
Placebo Gel
n=28 Participants
Placebo Gel: Vaginal gel
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 7.68 • n=99 Participants
|
30.0 years
STANDARD_DEVIATION 6.66 • n=107 Participants
|
29.5 years
STANDARD_DEVIATION 7.24 • n=206 Participants
|
30.6 years
STANDARD_DEVIATION 7.66 • n=7 Participants
|
29.8 years
STANDARD_DEVIATION 7.26 • n=31 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
111 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
27 participants
n=107 Participants
|
26 participants
n=206 Participants
|
28 participants
n=7 Participants
|
111 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 21-30Population: The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Outcome measures
| Measure |
0.5% SPL7013 Gel
n=30 Participants
0.5% SPL7013 Gel: Vaginal gel
|
1.0% SPL7013 Gel
n=26 Participants
1.0% SPL7013 Gel: Vaginal gel
|
3.0% SPL7013 Gel
n=25 Participants
3.0% SPL7013 Gel: Vaginal gel
|
Placebo Gel
n=26 Participants
Placebo Gel: Vaginal gel
|
|---|---|---|---|---|
|
Number of Women With Clinical Cure as a Measure of Efficacy
|
7 Participants
|
12 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 9-12Population: The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Outcome measures
| Measure |
0.5% SPL7013 Gel
n=29 Participants
0.5% SPL7013 Gel: Vaginal gel
|
1.0% SPL7013 Gel
n=27 Participants
1.0% SPL7013 Gel: Vaginal gel
|
3.0% SPL7013 Gel
n=24 Participants
3.0% SPL7013 Gel: Vaginal gel
|
Placebo Gel
n=27 Participants
Placebo Gel: Vaginal gel
|
|---|---|---|---|---|
|
Number of Women With Clinical Cure as a Measure of Efficacy
|
16 Participants
|
20 Participants
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 9-30Population: The analysis population was the mITT. Patients with a missing assessment due to early withdrawal were not analyzed.
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.
Outcome measures
| Measure |
0.5% SPL7013 Gel
n=29 Participants
0.5% SPL7013 Gel: Vaginal gel
|
1.0% SPL7013 Gel
n=26 Participants
1.0% SPL7013 Gel: Vaginal gel
|
3.0% SPL7013 Gel
n=25 Participants
3.0% SPL7013 Gel: Vaginal gel
|
Placebo Gel
n=27 Participants
Placebo Gel: Vaginal gel
|
|---|---|---|---|---|
|
Number of Women With Nugent Cure as a Measure of Efficacy
|
6 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 9-30Population: The analysis population is the mITT.
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.
Outcome measures
| Measure |
0.5% SPL7013 Gel
n=30 Participants
0.5% SPL7013 Gel: Vaginal gel
|
1.0% SPL7013 Gel
n=27 Participants
1.0% SPL7013 Gel: Vaginal gel
|
3.0% SPL7013 Gel
n=26 Participants
3.0% SPL7013 Gel: Vaginal gel
|
Placebo Gel
n=28 Participants
Placebo Gel: Vaginal gel
|
|---|---|---|---|---|
|
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
|
20 Participants
|
21 Participants
|
21 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
0.5% SPL7013 Gel
n=32 Participants
0.5% SPL7013 Gel: Vaginal gel
|
1.0% SPL7013 Gel
n=32 Participants
1.0% SPL7013 Gel: Vaginal gel
|
3.0% SPL7013 Gel
n=29 Participants
3.0% SPL7013 Gel: Vaginal gel
|
Placebo Gel
n=32 Participants
Placebo Gel: Vaginal gel
|
|---|---|---|---|---|
|
Incidence of Genital Adverse Events Potentially Related to Treatment
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
0.5% SPL7013 Gel
1.0% SPL7013 Gel
3.0% SPL7013 Gel
Placebo Gel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5% SPL7013 Gel
n=32 participants at risk
0.5% SPL7013 Gel: Vaginal gel
|
1.0% SPL7013 Gel
n=32 participants at risk
1.0% SPL7013 Gel: Vaginal gel
|
3.0% SPL7013 Gel
n=29 participants at risk
3.0% SPL7013 Gel: Vaginal gel
|
Placebo Gel
n=32 participants at risk
Placebo Gel: Vaginal gel
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
12.5%
4/32
|
6.2%
2/32
|
6.9%
2/29
|
12.5%
4/32
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
3.1%
1/32
|
6.2%
2/32
|
6.9%
2/29
|
0.00%
0/32
|
|
Infections and infestations
Vulvovaginal candidiasis
|
3.1%
1/32
|
3.1%
1/32
|
10.3%
3/29
|
3.1%
1/32
|
|
Reproductive system and breast disorders
Metrorrhagia
|
6.2%
2/32
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For a multicenter study, the PIs can only publish after the results of the trial have been published collectively.
- Publication restrictions are in place
Restriction type: OTHER