Trial Outcomes & Findings for Duration of Effect of Acidform Gel on Vaginal pH (NCT NCT02693418)

Last Updated: 2020-11-20

Results Overview

Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples was measured at pre-determined time points over the course of 7 days.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

105 participants

Primary outcome timeframe

Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Acidform Gel, Group A Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days	Acidform Gel, Group B Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days	Acidform Gel, Group C Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days	Placebo Gel, Group D Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days	No Intervention, Group E No vaginal product administered
Overall Study STARTED	22	21	21	20	21
Overall Study COMPLETED	21	19	19	20	21
Overall Study NOT COMPLETED	1	2	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Acidform Gel, Group A Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days	Acidform Gel, Group B Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days	Acidform Gel, Group C Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days	Placebo Gel, Group D Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days	No Intervention, Group E No vaginal product administered
Overall Study Lost to Follow-up	1	2	0	0	0
Overall Study Menses during study period	0	0	2	0	0

Baseline Characteristics

One subject in the IVAG acid form 3g group had missing weight data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acidform Gel, Group A n=22 Participants Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days	Acidform Gel, Group B n=21 Participants Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days	Acidform Gel, Group C n=21 Participants Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days	Placebo Gel, Group D n=20 Participants Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days	No Intervention, Group E n=21 Participants No vaginal product administered	Total n=105 Participants Total of all reporting groups
Age, Continuous	31.62 Years STANDARD_DEVIATION 7.11 • n=22 Participants	28.57 Years STANDARD_DEVIATION 7.20 • n=21 Participants	28.12 Years STANDARD_DEVIATION 5.40 • n=21 Participants	30.42 Years STANDARD_DEVIATION 6.47 • n=20 Participants	30.21 Years STANDARD_DEVIATION 6.45 • n=21 Participants	29.8 Years STANDARD_DEVIATION 6.57 • n=105 Participants
Sex: Female, Male Female	22 Participants n=22 Participants	21 Participants n=21 Participants	21 Participants n=21 Participants	20 Participants n=20 Participants	21 Participants n=21 Participants	105 Participants n=105 Participants
Sex: Female, Male Male	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=20 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=22 Participants	6 Participants n=21 Participants	2 Participants n=21 Participants	6 Participants n=20 Participants	3 Participants n=21 Participants	23 Participants n=105 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=22 Participants	15 Participants n=21 Participants	19 Participants n=21 Participants	14 Participants n=20 Participants	18 Participants n=21 Participants	82 Participants n=105 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=20 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=20 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants
Race (NIH/OMB) Asian	1 Participants n=22 Participants	0 Participants n=21 Participants	1 Participants n=21 Participants	0 Participants n=20 Participants	1 Participants n=21 Participants	3 Participants n=105 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=20 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants
Race (NIH/OMB) Black or African American	10 Participants n=22 Participants	11 Participants n=21 Participants	8 Participants n=21 Participants	6 Participants n=20 Participants	12 Participants n=21 Participants	47 Participants n=105 Participants
Race (NIH/OMB) White	10 Participants n=22 Participants	6 Participants n=21 Participants	11 Participants n=21 Participants	11 Participants n=20 Participants	7 Participants n=21 Participants	45 Participants n=105 Participants
Race (NIH/OMB) More than one race	1 Participants n=22 Participants	4 Participants n=21 Participants	1 Participants n=21 Participants	3 Participants n=20 Participants	1 Participants n=21 Participants	10 Participants n=105 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=20 Participants	0 Participants n=21 Participants	0 Participants n=105 Participants
Weight	169.54 pounds STANDARD_DEVIATION 49.56 • n=22 Participants • One subject in the IVAG acid form 3g group had missing weight data.	169.85 pounds STANDARD_DEVIATION 41.48 • n=21 Participants • One subject in the IVAG acid form 3g group had missing weight data.	183.81 pounds STANDARD_DEVIATION 52.97 • n=20 Participants • One subject in the IVAG acid form 3g group had missing weight data.	171.40 pounds STANDARD_DEVIATION 42.27 • n=20 Participants • One subject in the IVAG acid form 3g group had missing weight data.	177.09 pounds STANDARD_DEVIATION 48.91 • n=21 Participants • One subject in the IVAG acid form 3g group had missing weight data.	174.23 pounds STANDARD_DEVIATION 46.65 • n=104 Participants • One subject in the IVAG acid form 3g group had missing weight data.
Height	65.19 Inches STANDARD_DEVIATION 2.55 • n=22 Participants • One subject in the IVAG acid form 3g group had missing height data	64.62 Inches STANDARD_DEVIATION 2.27 • n=21 Participants • One subject in the IVAG acid form 3g group had missing height data	63.74 Inches STANDARD_DEVIATION 2.89 • n=20 Participants • One subject in the IVAG acid form 3g group had missing height data	63.91 Inches STANDARD_DEVIATION 2.47 • n=20 Participants • One subject in the IVAG acid form 3g group had missing height data	64.77 Inches STANDARD_DEVIATION 2.62 • n=21 Participants • One subject in the IVAG acid form 3g group had missing height data	64.46 Inches STANDARD_DEVIATION 2.57 • n=104 Participants • One subject in the IVAG acid form 3g group had missing height data
BMI	28.02 kg/m^2 STANDARD_DEVIATION 7.55 • n=22 Participants • One subject in the IVAG acid form 3g group did not have BMI data	28.59 kg/m^2 STANDARD_DEVIATION 6.69 • n=21 Participants • One subject in the IVAG acid form 3g group did not have BMI data	31.87 kg/m^2 STANDARD_DEVIATION 9.30 • n=20 Participants • One subject in the IVAG acid form 3g group did not have BMI data	29.84 kg/m^2 STANDARD_DEVIATION 8.51 • n=20 Participants • One subject in the IVAG acid form 3g group did not have BMI data	29.55 kg/m^2 STANDARD_DEVIATION 7.13 • n=21 Participants • One subject in the IVAG acid form 3g group did not have BMI data	29.53 kg/m^2 STANDARD_DEVIATION 7.82 • n=104 Participants • One subject in the IVAG acid form 3g group did not have BMI data

PRIMARY outcome

Timeframe: Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.

Population: Summary of Changes from Baseline (baseline value for vaginal pH is the Pre-Dose measurement on Day 0). Vaginal pH was obtained by the subject on Day 0 (12 hours post treatment only), Day 2, Day 3, Day 4, Day 5 and Day 6. All other vaginal pH values were obtained by the Research staff.

Outcome measures

Outcome measures
Measure	Acidform Gel, Group A n=22 Participants Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days	Acidform Gel, Group B n=21 Participants Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days	Acidform Gel, Group C n=21 Participants Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days	Placebo Gel, Group D n=20 Participants Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days	No Intervention, Group E n=21 Participants No vaginal product administered
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. Baseline measure (Day 0)	4.85 pH Standard Deviation 0.55	4.81 pH Standard Deviation 0.62	4.91 pH Standard Deviation 0.57	5.00 pH Standard Deviation .069	4.77 pH Standard Deviation 0.60
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. 1 hour Post-Tx Summary of Changes from Baseline	-0.44 pH Standard Deviation 0.50	-0.19 pH Standard Deviation 0.54	-0.30 pH Standard Deviation 0.66	-.031 pH Standard Deviation 0.55	-0.16 pH Standard Deviation 0.45
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. 6 hour Post-Tx Summary of Changes from Baseline	-0.59 pH Standard Deviation 0.50	-0.51 pH Standard Deviation 0.57	-0.49 pH Standard Deviation 0.47	-0.16 pH Standard Deviation 0.53	-0.02 pH Standard Deviation 0.50
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. 12 hour Post-tx Summary Changes from baseline	-0.76 pH Standard Deviation 0.57	-0.72 pH Standard Deviation 0.57	-0.58 pH Standard Deviation 0.70	-0.02 pH Standard Deviation 0.55	0.01 pH Standard Deviation 0.34
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. Day 1 Summary of Changes from Baseline	-0.72 pH Standard Deviation 0.55	-0.50 pH Standard Deviation 0.54	-0.29 pH Standard Deviation 0.65	-0.13 pH Standard Deviation 0.35	0.19 pH Standard Deviation 0.64
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. Day 2 Summary of Changes from Baseline	-0.33 pH Standard Deviation 0.42	-0.43 pH Standard Deviation 0.42	-0.25 pH Standard Deviation 0.39	0.23 pH Standard Deviation 0.65	-0.01 pH Standard Deviation 0.43
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. Day 3 Summary of Changes from Baseline	-0.40 pH Standard Deviation 0.43	-0.34 pH Standard Deviation 0.56	-0.10 pH Standard Deviation 0.50	0.05 pH Standard Deviation 0.64	0.04 pH Standard Deviation 0.47
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. Day 4 Summary of Changes from Baseline	-0.38 pH Standard Deviation 0.46	-0.34 pH Standard Deviation 0.39	-0.22 pH Standard Deviation 0.47	0.11 pH Standard Deviation 0.68	0.06 pH Standard Deviation 0.37
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. Day 5 Summary of Changes from Baseline	-0.36 pH Standard Deviation 0.44	-0.24 pH Standard Deviation 0.52	-0.25 pH Standard Deviation 0.36	-0.25 pH Standard Deviation 0.43	0.09 pH Standard Deviation 0.58
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. Day 6 Summary of Changes from Baseline	-0.46 pH Standard Deviation 0.51	-0.18 pH Standard Deviation 0.77	-0.24 pH Standard Deviation 0.49	-0.19 pH Standard Deviation 0.47	-0.01 pH Standard Deviation 0.62
Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. Day 7 Summary of Changes from Baseline	-0.14 pH Standard Deviation 0.50	-0.16 pH Standard Deviation 0.48	-0.19 pH Standard Deviation 0.48	-0.16 pH Standard Deviation 0.64	-0.06 pH Standard Deviation 0.52

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0), Day 1 and Day 7

Population: Day 0 (Baseline), Day 1 and Day 7, Amsel Tests Overall results

Amsel Criteria was used at baseline (day 0), compared to Day1 and Day 7 following the single dose of Acidform or placebo. Amsel criteria assessments consisted of Yes/No indications for the presence of each of the following: Vaginal pH\> 4.5; Presence of thin, grayish white vaginal discharge; Positive wet prep; Positive whiff amine test. Based on the individual criteria, a derived overall result (positive/negative) was reported. Amsel Result was automatically calculated based whether or not subject is positive in three of the four criteria listed above.