Trial Outcomes & Findings for LACTIN-V Study for Recurrent Bacterial Vaginosis (NCT NCT02766023)
NCT ID: NCT02766023
Last Updated: 2020-03-04
Results Overview
Adverse events and serious adverse events were collected during the entire study period. Relatedness to study product was assessed by the site investigator according to the protocol definition of related as "There is a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE."
COMPLETED
PHASE2
228 participants
Day 1 to Day 168
2020-03-04
Participant Flow
Participants were non-pregnant females with untreated bacterial vaginosis recruited from the clinics conducting the study and from other clinical providers coordinating referrals of eligible women to the study centers. Participants were enrolled between 03JUN2016 and 27AUG2018.
Participant milestones
| Measure |
LACTIN-V
Participants receive 5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally. Participants then receive LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks. N=152
Lactobacillus crispatus CTV-05: LACTIN-V is an intravaginal live biotherapeutic product composed of Lactobacillus crispatus CTV-05 (LACTIN-V, Osel Inc) in a vaginal applicator. Participants receive 2x10\^9 cfu/dose applied vaginally daily x 5 days then twice weekly x 10 weeks.
Metronidazole: Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days
|
Placebo
Participants receive 5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally. Participants then receive placebo applied vaginally for 5 days then twice weekly for 10 weeks. N=76
Metronidazole: Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days
Placebo: Placebo formulation applied vaginally, daily x 5 days then twice weekly x 10 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
76
|
|
Overall Study
COMPLETED
|
122
|
59
|
|
Overall Study
NOT COMPLETED
|
30
|
17
|
Reasons for withdrawal
| Measure |
LACTIN-V
Participants receive 5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally. Participants then receive LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks. N=152
Lactobacillus crispatus CTV-05: LACTIN-V is an intravaginal live biotherapeutic product composed of Lactobacillus crispatus CTV-05 (LACTIN-V, Osel Inc) in a vaginal applicator. Participants receive 2x10\^9 cfu/dose applied vaginally daily x 5 days then twice weekly x 10 weeks.
Metronidazole: Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days
|
Placebo
Participants receive 5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally. Participants then receive placebo applied vaginally for 5 days then twice weekly for 10 weeks. N=76
Metronidazole: Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days
Placebo: Placebo formulation applied vaginally, daily x 5 days then twice weekly x 10 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
11
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Not Eligible at Enrollment
|
0
|
1
|
Baseline Characteristics
LACTIN-V Study for Recurrent Bacterial Vaginosis
Baseline characteristics by cohort
| Measure |
LACTIN-V
n=152 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
152 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=5 Participants
|
76 participants
n=7 Participants
|
228 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 168Population: The safety population included all participants receiving study product. One participant randomized to LACTIN-V was not treated.
Adverse events and serious adverse events were collected during the entire study period. Relatedness to study product was assessed by the site investigator according to the protocol definition of related as "There is a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE."
Outcome measures
| Measure |
LACTIN-V
n=151 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm.
|
0.11 proportion of participants
Interval 0.06 to 0.16
|
0.07 proportion of participants
Interval 0.03 to 0.15
|
PRIMARY outcome
Timeframe: Day 1 to Day 84Population: The analysis population was the intent-to-treat population (all randomized participants). Missing BV recurrence data was imputed using Last Observation Carried Forward
A positive BV diagnosis was defined by meeting at least 3 of the 4 Amsel criteria and a Nugent score of 4-10. Amsel criteria are: homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; vaginal pH \>4.5; positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide is added to a sample of vaginal discharge; and presence of clue cells (\>20%) on microscopy. The Amsel score ranges from 0-4, where higher scores mean a worse outcome. The Nugent score is calculated by assessing for the presence of large Gram-positive rods scored as 0 to 4, small Gram-variable rods scored as 0 to 4, and curved Gram-variable rods scored as 0 to 2, and adding all component scores. The Nugent score ranges from 0-10, where higher scores mean a worse outcome. All BV diagnoses following 15 days after enrollment (22 days after commencement of MetroGel treatment) were considered a recurrent episode.
Outcome measures
| Measure |
LACTIN-V
n=152 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm.
|
0.30 proportion of participants
Interval 0.24 to 0.38
|
0.45 proportion of participants
Interval 0.34 to 0.56
|
SECONDARY outcome
Timeframe: Day 1 to Day 84Population: The analysis population was the intent-to-treat population (all randomized participants).
A subject was considered compliant with the assigned study product if she took 4 of the first 5 daily doses and at least 75% of the scheduled doses overall prior to the first diagnosis of BV or through Week 12, whichever occurred first. Compliance was assessed by subject report via the memory aid and, separately, applicator staining of the returned kit. Compliance was assessed on a weekly basis and the time (week) at which the subject became non-compliant was determined by blinded PI review.
Outcome measures
| Measure |
LACTIN-V
n=152 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining.
Self-report
|
0.80 proportion of participants
Interval 0.73 to 0.86
|
0.78 proportion of participants
Interval 0.67 to 0.86
|
|
The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining.
Staining
|
0.77 proportion of participants
Interval 0.7 to 0.83
|
0.72 proportion of participants
Interval 0.61 to 0.81
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes all treated participants who completed the questionnaire.
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by Likert-scale responses of strongly agree, agree, neutral, disagree and strongly disagree.
Outcome measures
| Measure |
LACTIN-V
n=130 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=63 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with ease of use of vaginal applicator · Disagree
|
1 Participants
|
2 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important I use product without partner knowing · Disagree
|
15 Participants
|
8 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I was satisfied overall with vaginal applicator · Strongly agree
|
59 Participants
|
22 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I was satisfied overall with vaginal applicator · Agree
|
55 Participants
|
30 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I was satisfied overall with vaginal applicator · Neutral
|
12 Participants
|
7 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I was satisfied overall with vaginal applicator · Disagree
|
3 Participants
|
4 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I was satisfied overall with vaginal applicator · Strongly disagree
|
1 Participants
|
0 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with comfort of vaginal applicator · Strongly agree
|
55 Participants
|
23 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with comfort of vaginal applicator · Agree
|
56 Participants
|
32 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with comfort of vaginal applicator · Neutral
|
17 Participants
|
5 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with comfort of vaginal applicator · Disagree
|
1 Participants
|
2 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with comfort of vaginal applicator · Strongly disagree
|
1 Participants
|
1 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with ease of use of vaginal applicator · Strongly agree
|
63 Participants
|
31 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with ease of use of vaginal applicator · Agree
|
58 Participants
|
28 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with ease of use of vaginal applicator · Neutral
|
8 Participants
|
2 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Satisfied with ease of use of vaginal applicator · Strongly disagree
|
0 Participants
|
0 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Vaginal health improved with study participation · Strongly agree
|
46 Participants
|
18 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Vaginal health improved with study participation · Agree
|
45 Participants
|
18 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Vaginal health improved with study participation · Neutral
|
25 Participants
|
21 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Vaginal health improved with study participation · Disagree
|
10 Participants
|
5 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Vaginal health improved with study participation · Strongly disagree
|
4 Participants
|
1 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important I use product without partner knowing · Strongly agree
|
32 Participants
|
12 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important I use product without partner knowing · Agree
|
29 Participants
|
15 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important I use product without partner knowing · Neutral
|
45 Participants
|
22 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important I use product without partner knowing · Strongly disagree
|
9 Participants
|
6 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important for me that partner approved of product · Strongly agree
|
10 Participants
|
6 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important for me that partner approved of product · Agree
|
22 Participants
|
10 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important for me that partner approved of product · Neutral
|
34 Participants
|
23 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important for me that partner approved of product · Disagree
|
34 Participants
|
13 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Important for me that partner approved of product · Strongly disagree
|
30 Participants
|
11 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I would use the product again · Strongly agree
|
72 Participants
|
28 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I would use the product again · Agree
|
39 Participants
|
24 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I would use the product again · Neutral
|
11 Participants
|
7 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I would use the product again · Disagree
|
4 Participants
|
3 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
I would use the product again · Strongly disagree
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes all treated participants who completed the questionnaire.
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including the question, "If a non-antibiotic, clinically proven lactobacillus product were available for treatment and prevention of BV, what are the chances that you would use it?"
Outcome measures
| Measure |
LACTIN-V
n=130 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=63 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use
Good possibility
|
14 Participants
|
7 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use
Certain; almost certain
|
83 Participants
|
37 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use
Very probable
|
25 Participants
|
16 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use
Slight possibility
|
8 Participants
|
2 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use
No chance; almost no chance
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes all treated participants who completed the questionnaire.
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including "My current partner's reaction to the product was..." with the options as listed below.
Outcome measures
| Measure |
LACTIN-V
n=130 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=63 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product
Currently does not have a partner
|
21 Participants
|
10 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product
Positive
|
39 Participants
|
23 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product
Neutral
|
31 Participants
|
16 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product
Negative
|
9 Participants
|
2 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product
Partner was unaware of product use
|
20 Participants
|
9 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product
Unknown
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes all treated participants who completed the questionnaire and had a current partner.
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including if their current partner's reaction to the product influenced their use of the product.
Outcome measures
| Measure |
LACTIN-V
n=109 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=53 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence
Yes, and was more likely to use it
|
19 Participants
|
9 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence
Yes, and was less likely to use it
|
2 Participants
|
0 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence
Unknown
|
15 Participants
|
8 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence
No
|
73 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes all treated participants who completed the questionnaire.
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including a Yes/No question about experiencing side effects.
Outcome measures
| Measure |
LACTIN-V
n=130 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=63 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects
No
|
81 Participants
|
44 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects
Yes
|
49 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population is limited to those participants who answered "Yes" to the question "Did you experience any side effects using the product?"
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including a Yes/No question about experiencing side effects. For those participants who answered Yes to experiencing side effects, a follow-up question asked "would these side effects make you less likely to use the product again?"
Outcome measures
| Measure |
LACTIN-V
n=49 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=19 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use
Strongly agree
|
2 Participants
|
1 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use
Agree
|
6 Participants
|
3 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use
Neutral
|
7 Participants
|
7 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use
Disagree
|
20 Participants
|
4 Participants
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use
Strongly disagree
|
14 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes all treated participants who completed the questionnaire.
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including by rating factors on a 0-10 scale, with 0 being "not at all" and 10 being "extremely".
Outcome measures
| Measure |
LACTIN-V
n=130 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=63 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product
Effectiveness
|
7.53 units on a scale
Standard Deviation 2.81
|
6.72 units on a scale
Standard Deviation 2.97
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product
Comfort
|
8.16 units on a scale
Standard Deviation 2.22
|
8.07 units on a scale
Standard Deviation 2.10
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product
Ease of use
|
8.99 units on a scale
Standard Deviation 1.57
|
8.75 units on a scale
Standard Deviation 1.75
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product
Vaginal health
|
7.37 units on a scale
Standard Deviation 2.83
|
7.01 units on a scale
Standard Deviation 2.88
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product
Other Finding
|
8.21 units on a scale
Standard Deviation 2.58
|
9.27 units on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes all treated participants who completed the questionnaire.
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including by rating factors on use of the product on a 0-10 scale, with 0 being "not at all" and 10 being "extremely so".
Outcome measures
| Measure |
LACTIN-V
n=130 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=63 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use
Other issue
|
7.08 units on a scale
Standard Deviation 1.69
|
7.62 units on a scale
Standard Deviation 1.68
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use
High frequency
|
2.97 units on a scale
Standard Deviation 3.20
|
2.63 units on a scale
Standard Deviation 3.09
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use
Vaginal Dryness
|
1.71 units on a scale
Standard Deviation 2.66
|
1.37 units on a scale
Standard Deviation 2.43
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use
Discomfort
|
1.53 units on a scale
Standard Deviation 2.43
|
1.01 units on a scale
Standard Deviation 1.80
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use
Messiness
|
2.10 units on a scale
Standard Deviation 2.82
|
1.68 units on a scale
Standard Deviation 2.65
|
|
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use
Disapproval
|
0.98 units on a scale
Standard Deviation 2.07
|
0.79 units on a scale
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: Day 1 to Day 84Population: The analysis population is intent to treat.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=152 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product in the LACTIN-V Arm Overall.
|
0.85 percentage of participants
Interval 0.78 to 0.9
|
0.07 percentage of participants
Interval 0.03 to 0.14
|
SECONDARY outcome
Timeframe: Day 1Population: The analysis population includes participants with results at the visit.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=149 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=75 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
Condom-less sex acts since last visit
|
0 Participants
|
0 Participants
|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
No condom-less sex acts since last visit
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: The analysis population includes participants with results at the visit.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=134 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=64 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
Condom-less sex acts since last visit
|
37 Participants
|
1 Participants
|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
No condom-less sex acts since last visit
|
76 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 56Population: The analysis population includes participants with results at the visit.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=127 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=58 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
Condom-less sex acts since last visit
|
28 Participants
|
0 Participants
|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
No condom-less sex acts since last visit
|
78 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes participants with results at the visit.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=131 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=63 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
Condom-less sex acts since last visit
|
38 Participants
|
0 Participants
|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
No condom-less sex acts since last visit
|
64 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: The analysis population includes participants with results at the visit.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=134 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=64 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
Menses since last visit
|
93 Participants
|
3 Participants
|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
No menses since last visit
|
20 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 56Population: The analysis population includes participants with results at the visit.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=127 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=58 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
Menses since last visit
|
76 Participants
|
1 Participants
|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
No menses since last visit
|
30 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: The analysis population includes participants with results at the visit.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=131 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=63 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
Menses since last visit
|
74 Participants
|
2 Participants
|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
No menses since last visit
|
28 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 168Population: The analysis population was the intent-to-treat population (all randomized participants).
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Outcome measures
| Measure |
LACTIN-V
n=152 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product Overall.
|
0.86 percentage of participants
Interval 0.8 to 0.91
|
0.08 percentage of participants
Interval 0.04 to 0.16
|
SECONDARY outcome
Timeframe: Day 1 to Day 168Population: The analysis population was the intent-to-treat population (all randomized participants).
A positive BV diagnosis was defined by at least 3 of the 4 Amsel criteria and a Nugent score of 4-10. Amsel criteria are: homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; vaginal pH \>4.5; positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide is added to a sample of vaginal discharge; and presence of clue cells (\>20%) on microscopy. The Nugent score is calculated by assessing for the presence of large Gram-positive rods scored as 0 to 4, small Gram-variable rods scored as 0 to 4, and curved Gram-variable rods scored as 0 to 2. All BV diagnoses following 15 days after enrollment (22 days after commencement of MetroGel treatment) were considered a recurrent episode.
Outcome measures
| Measure |
LACTIN-V
n=152 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm.
|
0.39 percentage of participants
Interval 0.31 to 0.47
|
0.54 percentage of participants
Interval 0.43 to 0.65
|
SECONDARY outcome
Timeframe: Day 1 to Day 84Population: The analysis population included all treated participants. One participant randomized to LACTIN-V was not treated.
Tolerability of LACTIN-V and the applicator was measured by the proportion of participants who discontinued the study product prior to completing the dose schedule due to an adverse event.
Outcome measures
| Measure |
LACTIN-V
n=151 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 Participants
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
The Number of Participants Who Discontinued Study Product Early in Each Study Arm Due to Adverse Events.
|
1 Participants
|
0 Participants
|
Adverse Events
LACTIN-V
Placebo
Serious adverse events
| Measure |
LACTIN-V
n=151 participants at risk
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 participants at risk
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.66%
1/151 • Number of events 1 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
0.00%
0/76 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
Other adverse events
| Measure |
LACTIN-V
n=151 participants at risk
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks.
|
Placebo
n=76 participants at risk
5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks.
|
|---|---|---|
|
Infections and infestations
Vulvovaginal candidiasis
|
9.3%
14/151 • Number of events 16 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
3.9%
3/76 • Number of events 3 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
7.3%
11/151 • Number of events 15 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
6.6%
5/76 • Number of events 5 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Vascular disorders
Hypertension
|
7.3%
11/151 • Number of events 12 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
5.3%
4/76 • Number of events 4 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
25.2%
38/151 • Number of events 38 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
28.9%
22/76 • Number of events 22 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
62.9%
95/151 • Number of events 95 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
60.5%
46/76 • Number of events 46 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Reproductive system and breast disorders
Vaginal odour
|
53.0%
80/151 • Number of events 80 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
44.7%
34/76 • Number of events 34 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Reproductive system and breast disorders
Pruritus genital
|
57.6%
87/151 • Number of events 87 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
44.7%
34/76 • Number of events 34 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Reproductive system and breast disorders
Genital discomfort
|
41.1%
62/151 • Number of events 62 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
26.3%
20/76 • Number of events 20 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Reproductive system and breast disorders
Genital swelling
|
19.9%
30/151 • Number of events 30 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
13.2%
10/76 • Number of events 10 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Reproductive system and breast disorders
Genital rash
|
13.9%
21/151 • Number of events 21 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
9.2%
7/76 • Number of events 7 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Gastrointestinal disorders
Nausea
|
17.2%
26/151 • Number of events 26 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
10.5%
8/76 • Number of events 8 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
15/151 • Number of events 15 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
9.2%
7/76 • Number of events 7 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Gastrointestinal disorders
Abdominal pain
|
39.1%
59/151 • Number of events 59 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
35.5%
27/76 • Number of events 27 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Gastrointestinal disorders
Diarrhea
|
20.5%
31/151 • Number of events 31 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
15.8%
12/76 • Number of events 12 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Gastrointestinal disorders
Constipation
|
22.5%
34/151 • Number of events 34 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
7.9%
6/76 • Number of events 6 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Renal and urinary disorders
Dysuria
|
19.2%
29/151 • Number of events 29 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
10.5%
8/76 • Number of events 8 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Renal and urinary disorders
Pollakiuria
|
23.8%
36/151 • Number of events 36 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
17.1%
13/76 • Number of events 13 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
|
Nervous system disorders
Headache
|
31.8%
48/151 • Number of events 48 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
21.1%
16/76 • Number of events 16 • All AEs and SAEs were collected through Study Week 24.
For events solicited on a Memory Aid, a participant was considered to have an event if it was reported as experienced at any time during the memory aid period.
|
Additional Information
Craig Cohen, MD, MPH
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60