Clinical trial NCT02709005: Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Assess the Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Vaginosis
Keywords: Bacterial Vaginosis
Monolaurin Vaginal Gel
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2016-03-15
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Participants With Clinical Cure in Each Study Arm
timeFrame: Visit 2 (Day 8-15)
measure: Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product
timeFrame: Days 1 through 5
measure: Number of Participants Reporting Serious Adverse Events (SAEs) Considered Product-related
timeFrame: Visit 1 (Day 1) through Visit 3 (Day 22-31)
Secondary outcomes:
measure: Number of Participants With Therapeutic Cure in Each Study Arm
timeFrame: Visit 2 (Day 8-15)
measure: Number of Participants With Therapeutic Cure in Each Study Arm
timeFrame: Visit 3 (Day 22-31)
measure: Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm
timeFrame: Visit 2 (Day 8-15)
measure: Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm
timeFrame: Visit 3 (Day 22-31)
measure: Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm
timeFrame: Visit 2 (Day 8-15)
measure: Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm
timeFrame: Visit 3 (Day 22-31)
measure: Number of Participants With Clinical Cure in Each Study Arm
timeFrame: Visit 3 (Day 22-31)
measure: Number of Participants Experiencing Non-laboratory Non-solicited AEs Following the First Dose of the Study Product
timeFrame: Visit 1 (Day 1) through Visit 3 (Day 22-31)
measure: Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product
timeFrame: Visit 2 (Day 8-15)
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa - Vaccine Research and Education Unit
state: Iowa
city: Durham
country: United States
facility: Duke Human Vaccine Institute - Duke Clinical Vaccine Unit
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center - Infectious Diseases
state: Ohio
Study officials:
References: