Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis

Bacterial vaginosis (BV) is a disease of the vagina caused by bacteria. The most common
symptom of BV is an abnormal homogeneous off-white vaginal discharge (especially after sex)
with an unpleasant smell. This is a Phase II, Double-Blind, Randomized, Placebo-Controlled,
Multi-center Trial enrolling 120 women, 18-50 years old, with clinical evidence of bacterial
vaginosis. Subjects will be randomized at a ratio of 2:1 to receive active test article (5%
Monolaurin Vaginal Gel) or placebo (vehicle) as outpatient therapy. Subjects will be
stratified by first time episode of bacterial vaginosis or recurrent bacterial vaginosis. The
primary objectives of this study are: 1) To assess the safety and tolerability of 5%
Monolaurin Vaginal Gel compared to Vehicle Placebo Gel (excipients only) and 2) To assess the
efficacy by clinical cure rate of 5% Monolaurin Vaginal Gel compared to Vehicle Placebo Gel
at Visit 2. The secondary objectives are : 1) To evaluate the therapeutic cure rate of 5%
Monolaurin Vaginal Gel compared to Vehicle Placebo Gel at Visits 2 and 3, 2) To evaluate the
clinical cure rate of 5% Monolaurin Vaginal Gel compared to Vehicle Placebo Gel at Visit 3,
3) To evaluate the changes in Nugent's criteria of vaginal bacterial flora at Visits 2 and 3.
This study is expected to last for 13 months, with subject participation duration being 4
weeks.

Inclusion Criteria:

- Non-pregnant, non-breastfeeding females between the ages of 18 and 50 years, inclusive

- Women of childbearing potential* must agree to practice reliable contraception** for
the 28-day period before enrollment through 30 days following treatment.

*(not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy,
or who have not been postmenopausal for >/=1 year)

** Acceptable birth control methods for the purposes of this study may include, but
are not limited to, abstinence from intercourse with a male partner, monogamous
relationship with vasectomized partner, barrier methods to include condoms and
diaphragms, intrauterine devices, and licensed hormonal methods. NuvaRing®
contraceptive use will be prohibited from this study since the device can alter
vaginal secretions

- Presenting with signs of BV (as per Amsel Criteria). Subjects must meet any three of
the four criteria for enrollment*

*Presence of discharge, greater than or equal to 20% clue cells on wet prep, positive
"whiff test" on KOH prep, vaginal pH of greater than 4.5

- Not currently menstruating or expected to in the next 4 days

- Able to understand and comply with planned study procedures

- Willing to abstain from sexual intercourse, insertion of tampons, douches, or other
intravaginal medications or objects between Visit 1 and Visit 2 and 48 hours prior to
Visit 3

- Provide written informed consent before initiation of any study procedures and be
available for all study visits

- No known history of HIV

Exclusion Criteria:

-Signs or symptoms of vaginal/cervical/pelvic infection on screening or clinical diagnosis
of vaginal/cervical/pelvic infection in the past 14 days.

- (including but not limited to yeast vulvovaginitis, chlamydia, gonorrhea, trichomonas,
genital ulcer disease, pelvic inflammatory disease). Self-treatment for presumed yeast
vaginitis is not an exclusion if treatment was discontinued 7 days or greater prior to
enrollment

- Treatment for BV within the past 14 days

- Cervical or vaginal high grade squamous intraepithelial dysplasia (HSIL),
atypical glandular cells of uncertain significance (AGUS) or cervical
intraepithelial neoplasia grade 2 (CIN2) or higher*

- Atypical squamous cells of undetermined significance (ASCUS), low grade squamous
intraepithelial lesion (LSIL) or cervical intraepithelial neoplasia grade 1 (CIN1) are
acceptable. Individuals with a history of atypical glandular cells of uncertain
significance (AGUS), HSIL or CIN2 and who have received subsequent evaluation and/or
treatment with follow up normal PAP smear are eligible. Patient report will be
accepted

- History of undiagnosed vaginal bleeding

- Use of a systemic, vaginal, or perineal antibiotic within 7 days prior to
enrollment in this study

- Use of an immunosuppressive or immunomodulatory drug* for two or more consecutive
weeks within 6 months prior to enrollment

- such as >0.5 mg/kg/day or >/=20 mg total dose/day of prednisone orally or >800 µg of
inhaled beclomethasone (nasal and non-genital topical steroids are allowed)

- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to Monolaurin Vaginal Gel

- Uncontrolled concurrent illness*. Subjects with a history of organ or marrow
transplant are excluded.

- Including, but not limited to, ongoing or active infection, active liver, kidney or
autoimmune diseases (a history of thyroid disease will be permitted as long as the
thyroid disease is now stable), symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

- Acute illness within 3 days before receipt of study product (per investigator's
discretion)

- Pregnant women and women who are planning to become pregnant within 30 days after
the final study dose, or women who are breastfeeding

- Immunosuppression as a result of an underlying illness or treatment or use of
anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36
months

- Active neoplastic disease* or a history of any hematologic malignancy. Active
neoplastic disease is defined as neoplastic disease or treatment for neoplastic
disease within the past 5 years

- (excluding non-melanoma skin cancer)

-Received an experimental agent* within 30 days before receipt of study product or
expect to receive an experimental agent during the 1 month study period.

- (vaccine, drug, biologic, device, blood product, or medication)

- Any condition that would place the subject at an unacceptable risk of injury,
render her unable to meet the requirements of the protocol, or that may interfere
with successful completion of the study

- A history of alcohol or drug abuse* during the previous 1 year that in the
opinion of the site investigator would interfere with study procedures

- For example, daily excessive alcohol use or frequent binge drinking as determined by
the investigator, or daily marijuana use