Trial Outcomes & Findings for Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis (NCT NCT02709005)

Last Updated: 2018-12-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

Visit 2 (Day 8-15)

Results posted on

2018-12-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Overall Study STARTED	73	36
Overall Study COMPLETED	69	35
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5% Monolaurin Vaginal Gel n=73 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=36 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Total n=109 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=5 Participants	36 Participants n=7 Participants	109 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.7 years STANDARD_DEVIATION 8.4 • n=5 Participants	31.3 years STANDARD_DEVIATION 8.4 • n=7 Participants	30.2 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	36 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	31 Participants n=7 Participants	99 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	45 Participants n=5 Participants	19 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	11 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	73 participants n=5 Participants	36 participants n=7 Participants	109 participants n=5 Participants
Nugent score <4	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Positive HIV, Chlamydia, or Neisseria gonorrhoeae test	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 2 (Day 8-15)

Population: The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score \<4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=64 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=32 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants With Clinical Cure in Each Study Arm	11 Participants	8 Participants

PRIMARY outcome

Timeframe: Days 1 through 5

Population: The safety population includes all randomized participants who received at least one dose of study treatment. If a subject did not have solicited symptom data she was not included. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.

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.

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=71 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=37 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product Vaginal Odor	10 Participants	6 Participants
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product Any Symptom	50 Participants	21 Participants
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product Vaginal Pain	16 Participants	5 Participants
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product Vaginal Tenderness	10 Participants	2 Participants
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product Vulvar/Vaginal Itching	23 Participants	9 Participants
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product Vaginal Dryness	10 Participants	3 Participants
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product Vaginal Discharge	12 Participants	8 Participants
Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product Vulvar Inflammation	9 Participants	2 Participants

PRIMARY outcome

Timeframe: Visit 1 (Day 1) through Visit 3 (Day 22-31)

Population: The safety population includes all randomized participants who received at least one dose of study treatment. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.

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.

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=72 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=37 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants Reporting Serious Adverse Events (SAEs) Considered Product-related	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=64 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=32 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants With Therapeutic Cure in Each Study Arm	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Visit 3 (Day 22-31)

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=64 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=32 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants With Therapeutic Cure in Each Study Arm	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=61 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=31 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Visit 3 (Day 22-31)

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=60 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=31 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm	5 Participants	8 Participants

SECONDARY outcome

Timeframe: Visit 2 (Day 8-15)

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=61 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=31 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm	8 Participants	3 Participants

SECONDARY outcome

Timeframe: Visit 3 (Day 22-31)

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=60 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=31 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm	9 Participants	3 Participants

SECONDARY outcome

Timeframe: Visit 3 (Day 22-31)

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=64 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=32 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants With Clinical Cure in Each Study Arm	10 Participants	5 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=72 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=37 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants Experiencing Non-laboratory Non-solicited AEs Following the First Dose of the Study Product	52 Participants	20 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	5% Monolaurin Vaginal Gel n=72 Participants Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=37 Participants 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product White blood cells Increase	3 Participants	0 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product Glucose Decrease	1 Participants	0 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product Creatinine Increase	1 Participants	1 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product AST Increase	1 Participants	0 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product Any Laboratory AE	12 Participants	7 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product Hemoglobin decrease	2 Participants	4 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product White blood cells Decrease	1 Participants	0 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product Platelets Decrease	1 Participants	0 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product Neutrophils Decrease	2 Participants	0 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product Glucose Increase	0 Participants	1 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product ALT Increase	1 Participants	2 Participants
Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product Bilirubin Increase	0 Participants	0 Participants

Adverse Events

5% Monolaurin Vaginal Gel

Serious events: 0 serious events

Other events: 59 other events

Deaths: 0 deaths

Vehicle Placebo

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	5% Monolaurin Vaginal Gel n=72 participants at risk Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.	Vehicle Placebo n=37 participants at risk 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. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses.
Reproductive system and breast disorders Vaginal Odour	5.6% 4/72 • Number of events 4 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	0.00% 0/37 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Reproductive system and breast disorders Vulvovaginal Pain	31.0% 22/71 • Number of events 22 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	13.5% 5/37 • Number of events 5 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Reproductive system and breast disorders Vulvovaginal Pruritus	4.2% 3/72 • Number of events 3 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	5.4% 2/37 • Number of events 2 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Reproductive system and breast disorders Vulvovaginal Dryness	14.1% 10/71 • Number of events 10 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	8.1% 3/37 • Number of events 3 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Reproductive system and breast disorders Vaginal Discharge	16.9% 12/71 • Number of events 12 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	21.6% 8/37 • Number of events 8 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Reproductive system and breast disorders Vulvovaginal Inflammation	12.7% 9/71 • Number of events 9 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	5.4% 2/37 • Number of events 2 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Gastrointestinal disorders Abdominal Pain	0.00% 0/72 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	5.4% 2/37 • Number of events 2 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Infections and infestations Gastroenteritis	1.4% 1/72 • Number of events 1 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	5.4% 2/37 • Number of events 2 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Infections and infestations Upper Respiratory Tract Infection	5.6% 4/72 • Number of events 4 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	13.5% 5/37 • Number of events 5 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Infections and infestations Vulvovaginal Mycotic Infection	8.3% 6/72 • Number of events 7 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	8.1% 3/37 • Number of events 3 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Reproductive system and breast disorders Vulvovaginal Burning Sensation	41.7% 30/72 • Number of events 46 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	10.8% 4/37 • Number of events 6 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Investigations Alanine aminotransferase increased	1.4% 1/72 • Number of events 1 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	5.4% 2/37 • Number of events 2 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Investigations Haemoglobin decreased	2.8% 2/72 • Number of events 2 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).	10.8% 4/37 • Number of events 4 • 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). Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).

Additional Information

Patricia Winokur, MD

University of Iowa Hospitals and Clinics

Phone: 319-384-4590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60