Status:
COMPLETED
Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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 art...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2017
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02709005
Start Date
April 14 2016
End Date
December 11 2017
Last Update
December 28 2018
Active Locations (3)
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1
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, United States, 52242-2600
2
Duke Human Vaccine Institute - Duke Clinical Vaccine Unit
Durham, North Carolina, United States, 27704
3
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, United States, 45229-3039