Duration of Effect of Acidform Gel on Vaginal pH

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.

Inclusion Criteria:

1. Healthy female subjects between 18 and 45 years, inclusive

2. Ability to understand the consent process and procedures

3. Subjects agree to be available for all study visits

4. Written informed consent in accordance with institutional guidelines

5. Negative pregnancy test

6. Able and willing to comply with all study procedures

7. Have not engaged in sexual intercourse, douching or used of any form of vaginal
suppository or intravaginal device for 24 hours prior to enrollment.

8. Agree to abstain from sexual intercourse, douching or any form of vaginal suppository
or intravaginal device use during course of study

9. Report menstrual cycle regularity (25- to 35- day menstrual cycles)

Exclusion Criteria:

1. Participation in any study with an investigational compound or device within 30 days
prior to signing informed consent

2. Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study protocol

3. Any other medical condition(s) that, in the judgment of the investigator, might
interfere with the study or require treatment that might interfere with the study

4. Family member of the investigation study staff

5. Pregnant or breast-feeding

6. Inability to provide informed consent

7. A subject with a history or expectation of noncompliance with medications or
treatment protocol

8. Women with symptoms of UTI or STI reported or observed during examination, at
screening*.

9. Women who regularly use douches, vaginal medications or suppositories, feminine
sprays, genital wipes or contraceptive spermicides, or report abnormal vaginal
discharge in the past 48 hours prior to screening

10. Women who are menstruating or who would expect to menstruate during the study

11. Women who are currently using contraceptives that are directly delivered to the
vaginal mucosa, such as NuvaRing

12. Any specific condition that, in the judgment of the Investigator, precludes
participation because it could affect subject safety