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

December 6, 2018 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242-2600
        • University of Iowa - Vaccine Research and Education Unit
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Duke Human Vaccine Institute - Duke Clinical Vaccine Unit
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center - Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 5% Monolaurin Vaginal Gel
80 subjects will receive 5% Monolaurin Gel twice daily for three successive days for a total of 6 doses
Drug: 5% Monolaurin Vaginal Gel
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.
Placebo Comparator: Vehicle Placebo
40 subjects will receive placebo Gel twice daily for three successive days for a total of 6 doses
Other: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Cure in Each Study Arm
Time Frame: Visit 2 (Day 8-15)
A clinical cure was defined by normal Amsel criteria, including: normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. All four criteria had to be normal with none of the clinical failure criteria met to be considered a clinical cure. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis.
Visit 2 (Day 8-15)
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product
Time Frame: Days 1 through 5
Solicited event assessments were captured on a memory aid starting on Day 1, the first day of therapy and continuing for 5 days. The participant recorded the presence and intensity of vulvovaginal solicited events on the memory aid. Any symptom that was present at the time that the participant was screened was considered as baseline and not reported as a solicited urogenital AE. However, if the symptom deteriorated during the reporting period, it was considered an AE. If a symptom was reported that was not present at baseline, it too was considered an AE. Any symptoms still present on Day 5 were followed by participant memory aid notations until symptom resolution. Solicited events collected include vaginal odor, vaginal pain, vaginal tenderness, vaginal itching, vaginal dryness, vaginal discharge, and vaginal inflammation. Severity of solicited events symptoms were graded as mild, moderate, or severe according to the grading table in the protocol.
Days 1 through 5
Number of Participants Reporting Serious Adverse Events (SAEs) Considered Product-related
Time Frame: Visit 1 (Day 1) through Visit 3 (Day 22-31)
The number of participants in each treatment group with product-related SAEs was assessed. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, or a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalizations could be considered serious when, based upon appropriate medical judgment, they could jeopardize the participant and require medical or surgical intervention to prevent one of the outcomes listed. An AE was considered related if there was a reasonable possibility that the study product caused the AE, meaning that there is evidence to suggest a causal relationship between the study product and the AE.
Visit 1 (Day 1) through Visit 3 (Day 22-31)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Therapeutic Cure in Each Study Arm
Time Frame: Visit 2 (Day 8-15)
Therapeutic cure was defined as both a clinical cure and a bacteriological cure. All four Amsel criteria had to be normal with none of the clinical failure criteria listed met to be considered a clinical cure, including normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis. A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures.
Visit 2 (Day 8-15)
Number of Participants With Therapeutic Cure in Each Study Arm
Time Frame: Visit 3 (Day 22-31)
Therapeutic cure was defined as both a clinical cure and a bacteriological cure. All four Amsel criteria had to be normal with none of the clinical failure criteria listed met to be considered a clinical cure, including normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis. A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures.
Visit 3 (Day 22-31)
Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm
Time Frame: Visit 2 (Day 8-15)
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.
Visit 2 (Day 8-15)
Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm
Time Frame: Visit 3 (Day 22-31)
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.
Visit 3 (Day 22-31)
Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm
Time Frame: Visit 2 (Day 8-15)
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.
Visit 2 (Day 8-15)
Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm
Time Frame: Visit 3 (Day 22-31)
A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.
Visit 3 (Day 22-31)
Number of Participants With Clinical Cure in Each Study Arm
Time Frame: Visit 3 (Day 22-31)
A clinical cure was defined by normal Amsel criteria, including: normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. All four criteria had to be normal with none of the clinical failure criteria met to be considered a clinical cure. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, requires additional treatment for vaginosis. Participants who did not have enough information to determine a clinical cure or clinical failure status were not evaluable for clinical cure.
Visit 3 (Day 22-31)
Number of Participants Experiencing Non-laboratory Non-solicited AEs Following the First Dose of the Study Product
Time Frame: Visit 1 (Day 1) through Visit 3 (Day 22-31)
The number of participants who experienced non-laboratory, non-solicited AEs following the first dose of the study product through Visit 3 (Day 22-31) was assessed. Events involving laboratory parameters that were not collected as part of the protocol were counted as non-laboratory, non-solicited adverse events.
Visit 1 (Day 1) through Visit 3 (Day 22-31)
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product
Time Frame: Visit 2 (Day 8-15)
The number of participants experiencing laboratory AEs following the first dose of the study product was assessed at Visit 2 (Day 8-15). A laboratory abnormality was considered an adverse event if there was a worsening of the laboratory value at Visit 2 from the baseline value and it increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined hematology parameters assessed were white blood cells, hemoglobin, platelets, and neutrophils. Protocol-defined clinical chemistry parameters assessed were creatinine, AST, ALT, total bilirubin, and glucose (random).
Visit 2 (Day 8-15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 19, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12-0021
  • HHSN272201300017I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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