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Trial record 1 of 3 for:    monolaurin
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Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis

This study is currently recruiting participants.
Verified July 19, 2017 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02709005
First Posted: March 15, 2016
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
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.

Condition Intervention Phase
Bacterial Vaginosis Drug: 5% Monolaurin Vaginal Gel Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Number of subjects reporting serious adverse events (SAEs) considered product-related [ Time Frame: Visit 3 (Day 22-31) ]
  • Number of subjects reporting solicited urogenital adverse events (AEs) following the first dose of the study product [ Time Frame: Visit 2 (Day 8-15) ]
  • Proportion of subjects with clinical cure in each study arm [ Time Frame: Visit 2 (Day 8-15) ]

Secondary Outcome Measures:
  • Number of subjects experiencing laboratory AEs following the first dose of the study product [ Time Frame: Visit 2(Day 8-15) ]
  • Number of subjects experiencing non-laboratory non-solicited AEs following the first dose of the study product [ Time Frame: Visit 3(Day 22-31) ]
  • Proportion of subjects with clinical cure in each study arm [ Time Frame: Visit 3(Day 22-31) ]
  • Proportion of subjects with Nugent score of 3 or less (negative for BV) 4-6 (intermediate) in each study arm [ Time Frame: Visit 2 (Day 8-15) and 3 (Day 22-31) ]
  • Proportion of subjects with therapeutic cure in each study arm [ Time Frame: Visit 2 (Day 8-15) and 3 (Day 22-31) ]

Estimated Enrollment: 120
Actual Study Start Date: April 14, 2016
Estimated Study Completion Date: February 23, 2018
Estimated Primary Completion Date: February 23, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709005


Contacts
Contact: Patricia Winokur 13193841735 patricia-winokur@uiowa.edu

Locations
United States, Iowa
University of Iowa - Vaccine Research and Education Unit Recruiting
Iowa City, Iowa, United States, 52242-2600
United States, North Carolina
Duke Human Vaccine Institute - Duke Clinical Vaccine Unit Recruiting
Durham, North Carolina, United States, 27704
United States, Ohio
Cincinnati Children's Hospital Medical Center - Infectious Diseases Recruiting
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02709005     History of Changes
Other Study ID Numbers: 12-0021
HHSN272200800008C
First Submitted: March 10, 2016
First Posted: March 15, 2016
Last Update Posted: September 29, 2017
Last Verified: July 19, 2017

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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Bacterial Vaginosis
Monolaurin Vaginal Gel

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis
Monolaurin
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs