Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: 5% Monolaurin Vaginal Gel; Placebo
Intervention description: Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration , and commonly referred to as glycerol monolaurate (GML). Each subject will receive intravaginal gel twice daily for three successive days for a total of 6 doses. There will be 3 clinic visits over 30 days.; The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Each subject will receive intravaginal gel twice daily for three successive days for a total of 6 doses. There will be 3 clinic visits over 30 days.
Intervention MeSH terms: Monolaurin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Bacterial Vaginosis; Monolaurin Vaginal Gel

Summary:

      This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial
      enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to
      receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary
      objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to
      vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5%
      Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.
    

Eligibility criteria:

        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