Duration of Effect of Acidform Gel on Vaginal pH
|ClinicalTrials.gov Identifier: NCT02693418|
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : November 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Acidform 5 g Drug: Placebo 4 g Drug: Acidform 4 g Drug: Acidform 3 g||Phase 1|
One hundred healthy volunteer women, 20 per each treatment arm, will be treated with either IVAG Acidform gel, 5 g dose (GROUP A), Acidform gel, 4 g dose (GROUP B), Acidform gel, 3 g dose (GROUP C), Universal Placebo Gel (UPG), 4 g (GROUP D) or no treatment (GROUP E). For GROUPS A, B, C and D, treatment is defined as speculum exam plus instillation of Investigational Product (IP) or placebo gel. For GROUP E (control), no treatment is defined as speculum exam and no gel instillation.
At least 15 women in each group will be of either African American or Hispanic ethnicity. Routine screening tests will be performed on admission; and subjects will be assessed for BV via vaginal swabs obtained for grading by Amsel criteria.
A direct vaginal pH reading will be research staff-obtained before the speculum exam, as well as one hour, and six hours post-treatment (Day 0). At the one hour and six hour post treatment time points, the direct vaginal pH readings will be taken on specimens collected from two different positions in the vagina, in case of incomplete distribution of the IP soon after administration. Both readings will be included as data points. At the six hour timepoint, subjects will be trained on self-collecting vaginal swabs and performing the vaginal pH test. At 12 hours post-treatment, subjects will perform the vaginal pH test themselves using self-obtained swabs, and record their results for clinician review.
Subjects will stay overnight in the domiciliary unit, and vaginal pH and Amsel criteria will be measured again by research staff at 24 (+/- 2) hours post-treatment before discharge on Day 1. The subjects will be discharged with the appropriate pH testing supplies and diary. All women must agree to abstain from sexual intercourse, douching and use of any intravaginally applied products or devices until after their final study visit on Day 7.
Subjects will measure their vaginal pH at 24 (+/-2) hour intervals for 5 days (Days 2-6) as outpatients and record the pH test results, and any change in vaginal comfort, in a provided diary. Subjects will also record any activities engaged in from the abstinence criteria in the study exclusion list, if applicable, each day. On Day 7, subjects will return to the clinic with their diaries, have their vaginal pH and Amsel criteria determined by the clinic staff, and queried as to any vaginal discomfort (vaginal comfort assessment) over the course of the study, as self-recorded in their diaries.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH|
|Actual Study Start Date :||August 24, 2016|
|Actual Primary Completion Date :||December 12, 2016|
|Actual Study Completion Date :||December 12, 2016|
Experimental: Acidform Gel, Group A
Administration of a single vaginal dose of Acidform gel (5 g)
Drug: Acidform 5 g
Effect of 5 g vaginally administered Acidform on pH over 7 days
Experimental: Acidform Gel, Group B
Administration of a single vaginal dose of Acidform gel (4 g)
Drug: Acidform 4 g
Effect of 4 g vaginally administered Acidform on pH over 7 days
Experimental: Acidform Gel, Group C
Administration of a single vaginal dose of Acidform gel (3 g)
Drug: Acidform 3 g
Effect of 3 g vaginally administered Acidform on pH over 7 days
Placebo Comparator: Placebo Gel, Group D
Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)
Drug: Placebo 4 g
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
No Intervention: No intervention, Group E
No vaginal product administered
- Vaginal pH following a single of Acidform (3, 4, and 5 g), HEC placebo (4 g), and no intervention [ Time Frame: 7 days ]Vaginal swabs will be used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples will be measured at pre-determined time points over the course of 7 days. pH data will be compared across interventions to determine an appropriate dose and dosing interval for a Phase 2 trial to determine the ability of Acidform to prevent recurrence of bacterial vaginosis.
- The effect of Acidform gel (3, 4 or 5 g), placebo gel (4 g), or no treatment on asymptomatic bacterial vaginosis (BV): Changes in Amsel Criteria between interventions. [ Time Frame: Baseine and 7 days ]Amsel Criteria will be used baseline and 7 days following the single dose. Changes in Amsel Criteria between interventions will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693418
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|United States, Ohio|
|Metro Health Medical Center|
|Cleveland, Ohio, United States, 44109|
|Principal Investigator:||Ann Avery, MD||Metro Health Medical Center|
|Principal Investigator:||Seema Nayak, MD||Johns Hopkins University|
|Study Director:||John M Griffiss, MD||Clinical Research Management, Inc.|