Trial Outcomes & Findings for A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause (NCT NCT04544475)

Last Updated: 2023-10-13

Results Overview

The VSQ (Vulvovaginal Symptoms Questionnaire) is a 21-question survey developed in 2012 that specifically asks about GSM symptoms, their emotional impact, sexual impact, and life impact. Each question is scored from 0 (free of discomfort) to 3 (severe discomfort) The total score ranges from 0 (symptom-free in all areas) to 63 (severe discomfort in all areas) - the higher the score, the more severe the discomfort.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2023-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care Estrace: Vaginal estrogen cream, estradiol: 100mcg
Overall Study STARTED	23	26
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care Estrace: Vaginal estrogen cream, estradiol: 100mcg
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational n=23 Participants Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care n=26 Participants Estrace: Vaginal estrogen cream, estradiol: 100mcg	Total n=49 Participants Total of all reporting groups
Age, Continuous	60 years n=93 Participants	59.5 years n=4 Participants	59.75 years n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	26 Participants n=4 Participants	49 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=93 Participants	22 Participants n=4 Participants	41 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants	20 Participants n=4 Participants	33 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment United States	23 participants n=93 Participants	26 participants n=4 Participants	49 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Outcome measures

Outcome measures
Measure	Investigational n=22 Participants Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care n=23 Participants Estrace: Vaginal estrogen cream, estradiol: 100mcg
Change in VSQ Score	-3.3 score on a scale Interval -5.5 to -1.1	-3.7 score on a scale Interval -6.0 to -1.3

SECONDARY outcome

Timeframe: Baseline, Week 12

VMI (Vaginal Maturation Index) is the microscopic analysis of vaginal tissue that assigns the percentage to the amount of squamous cells visualized. Only the % of squamous cells will be reported in this study since that is most closely correlated with hormonal influence on the vaginal tissue. Vaginal tissue sample will be obtained via scraping for VMI.

Outcome measures

Outcome measures
Measure	Investigational n=22 Participants Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care n=23 Participants Estrace: Vaginal estrogen cream, estradiol: 100mcg
Change in VMI	4.4 Percentage of squamous cells Interval -2.7 to 11.5	38.4 Percentage of squamous cells Interval 27.6 to 49.2

SECONDARY outcome

Timeframe: Baseline, Week 12

Pelvic samples will be collected to test vaginal pH.

Outcome measures

Outcome measures
Measure	Investigational n=22 Participants Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care n=23 Participants Estrace: Vaginal estrogen cream, estradiol: 100mcg
Change in Vaginal pH	-0.2 pH units Interval -0.3 to -0.1	-0.3 pH units Interval -0.4 to -0.1

SECONDARY outcome

Timeframe: Baseline, Week 12

VAS (Visual Analog Scale) score will be reported for dyspareunia. VAS is a visual scale attempting to capture the intensity of a symptom. For each symptom, the score ranges from 0-10. The higher the score, the more severe the symptom. Each symptom will be reported separately.

Outcome measures

Outcome measures
Measure	Investigational n=22 Participants Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care n=23 Participants Estrace: Vaginal estrogen cream, estradiol: 100mcg
Change in VAS Score - Dyspareunia	-3 score on a scale Interval -4.4 to -1.5	-3.6 score on a scale Interval -5.1 to -2.1

Adverse Events

Investigational

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Standard of Care

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Investigational n=22 participants at risk Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care n=23 participants at risk Estrace: Vaginal estrogen cream, estradiol: 100mcg
Nervous system disorders Seizure/syncope	0.00% 0/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked

Other adverse events

Other adverse events
Measure	Investigational n=22 participants at risk Revaree: Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.	Standard of Care n=23 participants at risk Estrace: Vaginal estrogen cream, estradiol: 100mcg
Infections and infestations Urinary Tract Infection	0.00% 0/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Infections and infestations Vulvovaginal candidasis	4.5% 1/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	0.00% 0/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Nervous system disorders Headache	0.00% 0/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Gastrointestinal disorders Abdominal cramping	0.00% 0/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Nervous system disorders Tingling in finger	0.00% 0/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Metabolism and nutrition disorders Weight gain	0.00% 0/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Reproductive system and breast disorders Vaginal discharge	4.5% 1/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Reproductive system and breast disorders Vaginal odor	0.00% 0/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Reproductive system and breast disorders Vaginal discomfort	0.00% 0/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	4.3% 1/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Reproductive system and breast disorders Vaginal burning sensation	9.1% 2/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	0.00% 0/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Reproductive system and breast disorders Vaginal irritation	4.5% 1/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	0.00% 0/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Reproductive system and breast disorders Vulvar itching	4.5% 1/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	0.00% 0/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Reproductive system and breast disorders Worsening of preexisting condition	4.5% 1/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	0.00% 0/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked
Reproductive system and breast disorders Pelvic heaviness	4.5% 1/22 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked	0.00% 0/23 • 12 Weeks Self-reporting by participants at any point during study or at follow up visit when asked

Additional Information

Lila Nachtigall

NYU Langone Health

Phone: 2122636361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place