A Phase 2 interventional study of 5% Monolaurin Vaginal Gel and Placebo in Bacterial Vaginosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 3 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-12-28.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
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.
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.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 109 is close to the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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
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
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)
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
(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)
80 subjects will receive 5% Monolaurin Gel twice daily for three successive days for a total of 6 doses
Drug: 5% Monolaurin Vaginal Gel
40 subjects will receive placebo Gel twice daily for three successive days for a total of 6 doses
Other: Placebo
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.
Number of Participants With Clinical Cure in Each Study Arm
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.
Time frame: Visit 2 (Day 8-15)
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product
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.
Time frame: Days 1 through 5
Number of Participants Reporting Serious Adverse Events (SAEs) Considered Product-related
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.
Time frame: Visit 1 (Day 1) through Visit 3 (Day 22-31)
Number of Participants With Therapeutic Cure in Each Study Arm
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.
Time frame: Visit 2 (Day 8-15)
Number of Participants With Therapeutic Cure in Each Study Arm
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.
Time frame: Visit 3 (Day 22-31)
Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm
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.
Time frame: Visit 2 (Day 8-15)
Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm
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.
Time frame: Visit 3 (Day 22-31)
Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm
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.
Time frame: Visit 2 (Day 8-15)
Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm
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.
Time frame: Visit 3 (Day 22-31)
Number of Participants With Clinical Cure in Each Study Arm
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.
Time frame: Visit 3 (Day 22-31)
Number of Participants Experiencing Non-laboratory Non-solicited AEs Following the First Dose of the Study Product
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.
Time frame: Visit 1 (Day 1) through Visit 3 (Day 22-31)
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product
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).
Time frame: Visit 2 (Day 8-15)
Women, 18-50 years old, with clinical evidence of bacterial vaginosis, were identified during a routine clinic visit, referred by their care provider, or recruited directly to the research clinic between May 11, 2016 and November 16, 2017.
| Milestone | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Started | 73 | 36 |
| Completed | 69 | 35 |
| Not completed | 4 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 0 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants With Clinical Cure in Each Study Arm | 11 | 8 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Any Symptom | 50 | 21 |
| Vaginal Odor | 10 | 6 |
| Vaginal Pain | 16 | 5 |
| Vaginal Tenderness | 10 | 2 |
| Vulvar/Vaginal Itching | 23 | 9 |
| Vaginal Dryness | 10 | 3 |
| Vaginal Discharge | 12 | 8 |
| Vulvar Inflammation | 9 | 2 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants Reporting Serious Adverse Events (SAEs) Considered Product-related | 0 | 0 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants With Therapeutic Cure in Each Study Arm | 2 | 1 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants With Therapeutic Cure in Each Study Arm | 0 | 3 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm | 2 | 1 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm | 5 | 8 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm | 8 | 3 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm | 9 | 3 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants With Clinical Cure in Each Study Arm | 10 | 5 |
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.
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Number of Participants Experiencing Non-laboratory Non-solicited AEs Following the First Dose of the Study Product | 52 | 20 |
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).
| Participants | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Any Laboratory AE | 12 | 7 |
| Hemoglobin decrease | 2 | 4 |
| White blood cells Increase | 3 | 0 |
| White blood cells Decrease | 1 | 0 |
| Platelets Decrease | 1 | 0 |
| Neutrophils Decrease | 2 | 0 |
| Glucose Decrease | 1 | 0 |
| Glucose Increase | 0 | 1 |
| Creatinine Increase | 1 | 1 |
| AST Increase | 1 | 0 |
| ALT Increase | 1 | 2 |
| Bilirubin Increase | 0 | 0 |
Collected over Solicited urogenital AEs were collected following the first dose of the study product (Day 1) through Day 5. Laboratory AEs were collected at Visit 2 (Day 8-15). Serious adverse events and non-laboratory non-solicited AEs were collected following the first dose of the study product (Day 1) through Visit 3 (Day 22-31).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 5% Monolaurin Vaginal Gel | 0/72 (0%) | 0/72 (0%) | 59/72 (81.9%) |
| Vehicle Placebo | 0/37 (0%) | 0/37 (0%) | 28/37 (75.7%) |
| Event | 5% Monolaurin Vaginal Gel | Vehicle Placebo |
|---|---|---|
| Vulvovaginal Burning SensationReproductive system and breast disorders | 30/72 | 4/37 |
| Vulvovaginal PruritusReproductive system and breast disorders | 23/71 | 9/37 |
| Vulvovaginal PainReproductive system and breast disorders | 22/71 | 5/37 |
| Vaginal DischargeReproductive system and breast disorders | 12/71 | 8/37 |
| Vaginal OdourReproductive system and breast disorders | 10/71 | 6/37 |
| Vulvovaginal DrynessReproductive system and breast disorders | 10/71 | 3/37 |
| Upper Respiratory Tract InfectionInfections and infestations | 4/72 | 5/37 |
| Vulvovaginal InflammationReproductive system and breast disorders | 9/71 | 2/37 |
| Haemoglobin decreasedInvestigations | 2/72 | 4/37 |
| Vulvovaginal Mycotic InfectionInfections and infestations | 6/72 | 3/37 |
| Age, Categorical(Participants) | 5% Monolaurin Vaginal Gel | Vehicle Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 73 | 36 | 109 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | 5% Monolaurin Vaginal Gel | Vehicle Placebo | Total |
|---|---|---|---|
| Mean | 29.7 ± 8.4 | 31.3 ± 8.4 | 30.2 ± 8.4 |
| Sex: Female, Male(Participants) | 5% Monolaurin Vaginal Gel | Vehicle Placebo | Total |
|---|---|---|---|
| Female | 73 | 36 | 109 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | 5% Monolaurin Vaginal Gel | Vehicle Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 68 | 31 | 99 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Race (NIH/OMB)(Participants) | 5% Monolaurin Vaginal Gel | Vehicle Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 45 | 19 | 64 |
| White | 26 | 11 | 37 |
| More than one race | 0 | 5 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 5% Monolaurin Vaginal Gel | Vehicle Placebo | Total |
|---|---|---|---|
| United States | 73 | 36 | 109 |
| Nugent score <4(Participants) | 5% Monolaurin Vaginal Gel | Vehicle Placebo | Total |
|---|---|---|---|
| Count of participants | 7 | 2 | 9 |
| Positive HIV, Chlamydia, or Neisseria gonorrhoeae test(Participants) | 5% Monolaurin Vaginal Gel | Vehicle Placebo | Total |
|---|---|---|---|
| Count of participants | 1 | 0 | 1 |
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