Duration of Effect of Acidform Gel on Vaginal pH

• Sponsor: Evofem Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02693418
• Collaborator: Clinical Research Management, Inc. (Industry), Johns Hopkins University (Other), MetroHealth Medical Center (Other)
• Enrollment: 105
• Locations: 2
• Arms: 5
• Actual Duration (Months): 3.6
• Patients Per Site: 52.5
• Patients Per Site Per Month: 14.5

Study Details

Study Description

Brief Summary

The objective of this study was to determine the magnitude and duration of the reduction in pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH was measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Acidform 5 g; Drug: Placebo 4 g; Drug: Acidform 4 g; Drug: Acidform 3 g	Phase 1

Detailed Description

One hundred healthy volunteer women, 20 per each treatment arm, were treated with either Intravaginal Acidform Gel(IVAG), 5 g dose (GROUP A), Acidform gel, 4 g dose (GROUP B), Acidform gel, 3 g dose (GROUP C), Universal Placebo Gel (UPG), 4 g (GROUP D) or no treatment (GROUP E). For GROUPS A, B, C and D, treatment is defined as speculum exam plus instillation of Investigational Product (IP) or placebo gel. For GROUP E (control), no treatment is defined as speculum exam and no gel instillation.

At least 15 women in each group were of either African American or Hispanic ethnicity. Routine screening tests were performed on admission; and subjects assessed for BV via vaginal swabs obtained for grading by Amsel criteria.

A direct vaginal pH reading by research staff- was obtained before the speculum exam, as well as one hour, and six hours post-treatment (Day 0). At the one hour and six hour post treatment time points, the direct vaginal pH readings were taken on specimens collected from two different positions in the vagina, in case of incomplete distribution of the IP soon after administration. Both readings are included as data points. At the six hour timepoint, subjects were trained on self-collecting vaginal swabs and performing the vaginal pH test. At 12 hours post-treatment, subjects performed the vaginal pH test themselves using self-obtained swabs, and record their results for clinician review.

Subjects stayed overnight in the domiciliary unit, and vaginal pH and Amsel criteria was measured again by research staff at 24 (+/- 2) hours post-treatment before discharge on Day

1. The subjects were discharged with the appropriate pH testing supplies and diary. All women agreed to abstain from sexual intercourse, douching and use of any intravaginally applied products or devices until after their final study visit on Day 7.

Subjects measured their vaginal pH at 24 (+/-2) hour intervals for 5 days (Days 2-6) as outpatients and recorded the pH test results, and any change in vaginal comfort, in a provided diary. Subjects also recorded any activities engaged in from the abstinence criteria in the study exclusion list, if applicable, each day. On Day 7, subjects returned to the clinic with their diaries, had their vaginal pH and Amsel criteria determined by the clinic staff, and queried as to any vaginal discomfort (vaginal comfort assessment) over the course of the study, as self-recorded in their diaries.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH
• Actual Study Start Date: Aug 24, 2016
• Actual Primary Completion Date: Dec 12, 2016
• Actual Study Completion Date: Dec 12, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acidform Gel, Group A Administration of a single vaginal dose of Acidform gel (5 g)	Drug: Acidform 5 g; Effect of 5 g vaginally administered Acidform on pH over 7 days
Experimental: Acidform Gel, Group B Administration of a single vaginal dose of Acidform gel (4 g)	Drug: Acidform 4 g; Effect of 4 g vaginally administered Acidform on pH over 7 days
Experimental: Acidform Gel, Group C Administration of a single vaginal dose of Acidform gel (3 g)	Drug: Acidform 3 g; Effect of 3 g vaginally administered Acidform on pH over 7 days
Placebo Comparator: Placebo Gel, Group D Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g)	Drug: Placebo 4 g; Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days; Other Names: Natrasol 250 HX Pharm
No Intervention: No intervention, Group E No vaginal product administered

Outcome Measures

Primary Outcome Measures

1. Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. [Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.]

   Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples was measured at pre-determined time points over the course of 7 days.

Other Outcome Measures

1. The Effect of a Single Dose of Acidform Gel (3, 4 or 5 g), Placebo Gel (4 g), or no Treatment on Asymptomatic Bacterial Vaginosis (BV) Based on Amsel Criteria. [Baseline (Day 0), Day 1 and Day 7]

   Amsel Criteria was used at baseline (day 0), compared to Day1 and Day 7 following the single dose of Acidform or placebo. Amsel criteria assessments consisted of Yes/No indications for the presence of each of the following: Vaginal pH> 4.5; Presence of thin, grayish white vaginal discharge; Positive wet prep; Positive whiff amine test. Based on the individual criteria, a derived overall result (positive/negative) was reported. Amsel Result was automatically calculated based whether or not subject is positive in three of the four criteria listed above.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy female subjects between 18 and 45 years, inclusive

2. Ability to understand the consent process and procedures

3. Subjects agree to be available for all study visits

4. Written informed consent in accordance with institutional guidelines

5. Negative pregnancy test

6. Able and willing to comply with all study procedures

7. Have not engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device for 24 hours prior to enrollment.

8. Agree to abstain from sexual intercourse, douching or any form of vaginal suppository or intravaginal device use during course of study

9. Report menstrual cycle regularity (25- to 35- day menstrual cycles)

Exclusion Criteria:

1. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent

2. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol

3. Any other medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment that might interfere with the study

4. Family member of the investigation study staff

5. Pregnant or breast-feeding

6. Inability to provide informed consent

7. A subject with a history or expectation of noncompliance with medications or treatment protocol

8. Women with symptoms of Urinary Tract Infection (UTI) or Sexually Transmitted Infection (STI) reported or observed during examination, at screening*.

9. Women who regularly use douches, vaginal medications or suppositories, feminine sprays, genital wipes or contraceptive spermicides, or report abnormal vaginal discharge in the past 48 hours prior to screening

10. Women who are menstruating or who would expect to menstruate during the study

11. Women who are currently using contraceptives that are directly delivered to the vaginal mucosa, such as NuvaRing

12. Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224
2	Metro Health Medical Center	Cleveland	Ohio	United States	44109

Sponsors and Collaborators

• Evofem Inc.
• Clinical Research Management, Inc.
• Johns Hopkins University
• MetroHealth Medical Center

Investigators

• Principal Investigator: Ann Avery, MD, Metro Health Medical Center
• Principal Investigator: Seema Nayak, MD, Johns Hopkins University
• Study Director: John M Griffiss, MD, Clinical Research Management, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Evofem Inc.
• ClinicalTrials.gov Identifier: NCT02693418
• Other Study ID Numbers: EVO-002
• First Posted: Feb 26, 2016
• Last Update Posted: Nov 20, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided

Study Results

Participant Flow

Arm/Group Title	Acidform Gel, Group A	Acidform Gel, Group B	Acidform Gel, Group C	Placebo Gel, Group D	No Intervention, Group E
Arm/Group Description	Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days	Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days	Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days	Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days	No vaginal product administered
Period Title: Overall Study
STARTED	22	21	21	20	21
COMPLETED	21	19	19	20	21
NOT COMPLETED	1	2	2	0	0

Baseline Characteristics

Arm/Group Title	Acidform Gel, Group A	Acidform Gel, Group B	Acidform Gel, Group C	Placebo Gel, Group D	No Intervention, Group E	Total
Arm/Group Description	Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days	Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days	Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days	Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days	No vaginal product administered	Total of all reporting groups
Overall Participants	22	21	21	20	21	105
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	31.62 (7.11)	28.57 (7.20)	28.12 (5.40)	30.42 (6.47)	30.21 (6.45)	29.8 (6.57)
Sex: Female, Male (Count of Participants)
Female	22 100%	21 100%	21 100%	20 100%	21 100%	105 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 27.3%	6 28.6%	2 9.5%	6 30%	3 14.3%	23 21.9%
Not Hispanic or Latino	16 72.7%	15 71.4%	19 90.5%	14 70%	18 85.7%	82 78.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 4.5%	0 0%	1 4.8%	0 0%	1 4.8%	3 2.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	10 45.5%	11 52.4%	8 38.1%	6 30%	12 57.1%	47 44.8%
White	10 45.5%	6 28.6%	11 52.4%	11 55%	7 33.3%	45 42.9%
More than one race	1 4.5%	4 19%	1 4.8%	3 15%	1 4.8%	10 9.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	169.54 (49.56)	169.85 (41.48)	183.81 (52.97)	171.40 (42.27)	177.09 (48.91)	174.23 (46.65)
Height (Inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Inches]	65.19 (2.55)	64.62 (2.27)	63.74 (2.89)	63.91 (2.47)	64.77 (2.62)	64.46 (2.57)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.02 (7.55)	28.59 (6.69)	31.87 (9.30)	29.84 (8.51)	29.55 (7.13)	29.53 (7.82)

Outcome Measures

1. Primary Outcome

Title	Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention.
Description	Vaginal swabs were used to collect samples from the vagina of women dosed with Acidform, HEC placebo, or no treatment. The pH of the samples was measured at pre-determined time points over the course of 7 days.
Time Frame	Baseline (Day 0), 1, 6 & 12 hours post treatment, and Days 1, 2, 3, 4, 5, 6 & 7.

Outcome Measure Data

Analysis Population Description

Summary of Changes from Baseline (baseline value for vaginal pH is the Pre-Dose measurement on Day 0). Vaginal pH was obtained by the subject on Day 0 (12 hours post treatment only), Day 2, Day 3, Day 4, Day 5 and Day 6. All other vaginal pH values were obtained by the Research staff.

Arm/Group Title	Acidform Gel, Group A	Acidform Gel, Group B	Acidform Gel, Group C	Placebo Gel, Group D	No Intervention, Group E
Arm/Group Description	Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days	Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days	Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days	Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days	No vaginal product administered
Measure Participants	22	21	21	20	21
Baseline measure (Day 0)	4.85 (0.55)	4.81 (0.62)	4.91 (0.57)	5.00 (.069)	4.77 (0.60)
1 hour Post-Tx Summary of Changes from Baseline	-0.44 (0.50)	-0.19 (0.54)	-0.30 (0.66)	-.031 (0.55)	-0.16 (0.45)
6 hour Post-Tx Summary of Changes from Baseline	-0.59 (0.50)	-0.51 (0.57)	-0.49 (0.47)	-0.16 (0.53)	-0.02 (0.50)
12 hour Post-tx Summary Changes from baseline	-0.76 (0.57)	-0.72 (0.57)	-0.58 (0.70)	-0.02 (0.55)	0.01 (0.34)
Day 1 Summary of Changes from Baseline	-0.72 (0.55)	-0.50 (0.54)	-0.29 (0.65)	-0.13 (0.35)	0.19 (0.64)
Day 2 Summary of Changes from Baseline	-0.33 (0.42)	-0.43 (0.42)	-0.25 (0.39)	0.23 (0.65)	-0.01 (0.43)
Day 3 Summary of Changes from Baseline	-0.40 (0.43)	-0.34 (0.56)	-0.10 (0.50)	0.05 (0.64)	0.04 (0.47)
Day 4 Summary of Changes from Baseline	-0.38 (0.46)	-0.34 (0.39)	-0.22 (0.47)	0.11 (0.68)	0.06 (0.37)
Day 5 Summary of Changes from Baseline	-0.36 (0.44)	-0.24 (0.52)	-0.25 (0.36)	-0.25 (0.43)	0.09 (0.58)
Day 6 Summary of Changes from Baseline	-0.46 (0.51)	-0.18 (0.77)	-0.24 (0.49)	-0.19 (0.47)	-0.01 (0.62)
Day 7 Summary of Changes from Baseline	-0.14 (0.50)	-0.16 (0.48)	-0.19 (0.48)	-0.16 (0.64)	-0.06 (0.52)

2. Other Pre-specified Outcome

Title	The Effect of a Single Dose of Acidform Gel (3, 4 or 5 g), Placebo Gel (4 g), or no Treatment on Asymptomatic Bacterial Vaginosis (BV) Based on Amsel Criteria.
Description	Amsel Criteria was used at baseline (day 0), compared to Day1 and Day 7 following the single dose of Acidform or placebo. Amsel criteria assessments consisted of Yes/No indications for the presence of each of the following: Vaginal pH> 4.5; Presence of thin, grayish white vaginal discharge; Positive wet prep; Positive whiff amine test. Based on the individual criteria, a derived overall result (positive/negative) was reported. Amsel Result was automatically calculated based whether or not subject is positive in three of the four criteria listed above.
Time Frame	Baseline (Day 0), Day 1 and Day 7

Outcome Measure Data

Analysis Population Description

Day 0 (Baseline), Day 1 and Day 7, Amsel Tests Overall results

Arm/Group Title	Acidform Gel, Group A	Acidform Gel, Group B	Acidform Gel, Group C	Placebo Gel, Group D	No Intervention, Group E
Arm/Group Description	Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days	Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days	Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days	Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days	No vaginal product administered
Measure Participants	22	21	21	20	21
Baseline Day 0 Positive	4 18.2%	2 9.5%	1 4.8%	4 20%	1 4.8%
Baseline Day 0 Negative	18 81.8%	19 90.5%	20 95.2%	16 80%	20 95.2%
Day 1 Positive	0 0%	2 9.5%	1 4.8%	1 5%	3 14.3%
Day 1 Negative	20 90.9%	18 85.7%	19 90.5%	18 90%	17 81%
Day 7 Positive	1 4.5%	2 9.5%	1 4.8%	2 10%	1 4.8%
Day 7 Negative	18 81.8%	16 76.2%	16 76.2%	18 90%	20 95.2%

Adverse Events

Time Frame	7 days
Arm/Group Title	Acidform Gel, Group A		Acidform Gel, Group B		Acidform Gel, Group C		Placebo Gel, Group D		No Intervention, Group E
Arm/Group Description	Administration of a single vaginal dose of Acidform gel (5 g) Acidform 5 g: Effect of 5 g vaginally administered Acidform on pH over 7 days		Administration of a single vaginal dose of Acidform gel (4 g) Acidform 4 g: Effect of 4 g vaginally administered Acidform on pH over 7 days		Administration of a single vaginal dose of Acidform gel (3 g) Acidform 3 g: Effect of 3 g vaginally administered Acidform on pH over 7 days		Administration of a single dose of hydroxyethylcellulose (HEC) placebo gel (4 g) Placebo 4 g: Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days		No vaginal product administered
All Cause Mortality
	Acidform Gel, Group A		Acidform Gel, Group B		Acidform Gel, Group C		Placebo Gel, Group D		No Intervention, Group E
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/21 (0%)		0/21 (0%)		0/20 (0%)		0/21 (0%)
Serious Adverse Events
	Acidform Gel, Group A		Acidform Gel, Group B		Acidform Gel, Group C		Placebo Gel, Group D		No Intervention, Group E
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/21 (0%)		0/21 (0%)		0/20 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Acidform Gel, Group A		Acidform Gel, Group B		Acidform Gel, Group C		Placebo Gel, Group D		No Intervention, Group E
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/22 (72.7%)		13/21 (61.9%)		16/21 (76.2%)		13/20 (65%)		10/21 (47.6%)
Infections and infestations
Nasopharyngitis	0/22 (0%)	0	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	1/21 (4.8%)	1
Urinary Tract Infection	1/22 (4.5%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0
Musculoskeletal and connective tissue disorders
Muscle Spasms	1/22 (4.5%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0
Nervous system disorders
Headache	1/22 (4.5%)	1	0/21 (0%)	0	0/21 (0%)	0	1/20 (5%)	1	1/21 (4.8%)	1
Sciatica	1/22 (4.5%)	1	0/21 (0%)	0	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0
Renal and urinary disorders
Micturition urgency	0/22 (0%)	0	1/21 (4.8%)	1	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0
Pollakiuria	0/22 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0
Reproductive system and breast disorders
Cervical discharge	1/22 (4.5%)	1	1/21 (4.8%)	1	2/21 (9.5%)	2	2/20 (10%)	2	3/21 (14.3%)	3
Cervix disorder	1/22 (4.5%)	1	0/21 (0%)	0	1/21 (4.8%)	1	2/20 (10%)	2	1/21 (4.8%)	1
Cervix inflamation	0/22 (0%)	0	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0
Dysmenorrhoea	0/22 (0%)	0	2/21 (9.5%)	2	0/21 (0%)	0	0/20 (0%)	0	0/21 (0%)	0
Menstruation irregular	1/22 (4.5%)	1	0/21 (0%)	0	1/21 (4.8%)	1	0/20 (0%)	0	0/21 (0%)	0
Vaginal discharge	15/22 (68.2%)	19	13/21 (61.9%)	19	12/21 (57.1%)	18	10/20 (50%)	14	3/21 (14.3%)	4
Vaginal haemorrhage	0/22 (0%)	0	1/21 (4.8%)	1	1/21 (4.8%)	1	3/20 (15%)	3	1/21 (4.8%)	1
Vaginal odour	0/22 (0%)	0	0/21 (0%)	0	2/21 (9.5%)	2	0/20 (0%)	0	0/21 (0%)	0
Vulvovaginal burning sensation	1/22 (4.5%)	2	0/21 (0%)	0	1/21 (4.8%)	2	0/20 (0%)	0	0/21 (0%)	0
Vulvovaginal discomfort	1/22 (4.5%)	1	0/21 (0%)	0	2/21 (9.5%)	2	0/20 (0%)	0	0/21 (0%)	0
Vulvovaginal pain	1/22 (4.5%)	1	1/21 (4.8%)	1	0/21 (0%)	0	1/20 (5%)	1	2/21 (9.5%)	2
Vulvovaginal pruritus	3/22 (13.6%)	3	2/21 (9.5%)	3	1/21 (4.8%)	1	3/20 (15%)	3	0/21 (0%)	0

Limitations/Caveats

Low number of subjects at each time point and lost specimens meant a complete analyses were not conducted on specimens from all subjects at all time points and further studies are required to confirm these findings.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.