Trial Outcomes & Findings for Safety Study of Lactobacillus Administered Vaginally to Healthy Women (NCT NCT00537576)

Results Overview

Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

35 days

Results posted on

2020-09-16

Participant Flow

Between November 2007 and January 2008, 12 participants were recruited through advertising in health centers, educational institutions, community bulletin boards and online forums.

All 12 enrolled participants completed the study.

Participant milestones

Participant milestones
Measure	Low Dose Applicator Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10\^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium Dose Applicator Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10\^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High Dose Applicator High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10\^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo Control Substance Low Dose Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo Control Substance Medium Dose Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo Control Substance High Dose Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
Overall Study STARTED	3	3	3	1	1	1
Overall Study COMPLETED	3	3	3	1	1	1
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Lactobacillus Administered Vaginally to Healthy Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Applicator n=3 Participants Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10\^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium Dose Applicator n=3 Participants Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10\^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High Dose Applicator n=3 Participants High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10\^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo Control Substance Low Dose n=1 Participants Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo Control Substance Medium Dose n=1 Participants Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo Control Substance High Dose n=1 Participants Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.	Total n=12 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	12 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Continuous	29.1 years STANDARD_DEVIATION 7.0 • n=5 Participants	29.1 years STANDARD_DEVIATION 7 • n=7 Participants	29.1 years STANDARD_DEVIATION 7.0 • n=5 Participants	29.1 years STANDARD_DEVIATION 7 • n=4 Participants	29.1 years STANDARD_DEVIATION 7 • n=21 Participants	29.1 years STANDARD_DEVIATION 7 • n=10 Participants	29.1 years STANDARD_DEVIATION 7.0 • n=115 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	12 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	1 participants n=10 Participants	12 participants n=115 Participants

PRIMARY outcome

Timeframe: 35 days

Population: The analysis was per protocol. Number of participants for descriptive analysis only.

Safety was measured by comparing the number of women experiencing adverse events of grade 3 or higher during the study.

Outcome measures

Outcome measures
Measure	Low Dose Applicator n=3 Participants Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10\^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium Dose Applicator n=3 Participants Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10\^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High Dose Applicator n=3 Participants High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10\^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo Control Substance Low Dose n=1 Participants Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo Control Substance Medium Dose n=1 Participants Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo Control Substance High Dose n=1 Participants Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
Safety of LACTIN-V in Healthy Pre-menopausal Women.	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 35 days

Population: Analysis per Protocol. Number of participants for descriptive analysis.

Tolerability was measured as proportion of women remaining in the study, and NOT prematurely exiting the trial due to an adverse event.

Outcome measures

Outcome measures
Measure	Low Dose Applicator n=3 Participants Low dose LACTIN-V applicator (150 mg LACTIN-V, 5.0 x 10\^8 CFU) and Placebo applicator (150 mg Placebo), randomized 3:1	Medium Dose Applicator n=3 Participants Medium dose LACTIN-V applicator (300 mg LACTIN-V, 1.0 x 10\^9 CFU) and Placebo applicator (300 mg), randomized 3:1	High Dose Applicator n=3 Participants High dose LACTIN-V applicator (600 mg LACTIN-V, 2.0 x 10\^9 CFU) and Placebo applicator (600 mg Placebo), randomized 3:1	Placebo Control Substance Low Dose n=1 Participants Placebo control substance Low Dose contained a nutrient matrix of 150 mg per dose.	Placebo Control Substance Medium Dose n=1 Participants Placebo control substance Medium Dose contained a nutrient matrix of 300 mg per dose.	Placebo Control Substance High Dose n=1 Participants Placebo control substance High Dose contained a nutrient matrix of 600 mg per dose.
Tolerability of LACTIN-V in a Pre-filled Applicator.	3 participants	3 participants	3 participants	1 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: 35 days

Acceptability and overall satisfaction with the study product was measured using the response to the following question: "I would use the product again" with the following response options (strongly agree, agree, neutral, disagree, strongly disagree) Acceptability is reported as the number of women in each group who strongly agreed or agreed with the statement that they would use the product again.