Genitourinary Syndrome of Menopause (GSM)
Conditions
Brief summary
Non-hormonal alternatives for the treatment of genitourinary syndrome of menopause (GSM) are needed. In this proposed trial, patients who are diagnosed with GSM will be randomized to receive either a hyaluronic acid (HLA) vaginal insert or vaginal estrogen topical cream for 12 weeks. There will be a baseline visit and an 12 week follow up visit, at which points the patient will undergo a detailed history and physical examination including a pelvic exam, vaginal pH sampling, vaginal cell sample for microscopic analysis, and will fill out a vulvovaginal symptom questionnaire (VSQ). These study arms will be analyzed to assess the efficacy of HLA as compared to the gold standard of vaginal estrogen to treat GSM symptoms.
Interventions
DEVICERevaree
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.
DRUGEstrace
Vaginal estrogen cream, estradiol: 100mcg
Sponsors
JDS Therapeutics, LLC
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Postmenopausal status as defined by amenorrhea for \>12 months or history of bilateral salpingo-oophrectomy or if the patient has had a hysterectomy and menopausal symptoms for \>1 year or FSH \> 40 2. Symptoms of GSM 3. Negative Pap smear as per ASCCP guidelines 4. Capable of giving informed consent 5. Ambulatory 6. Capable and willing to follow all study-relation procedures
Exclusion criteria
1. Use of any HRT (systemic or local) or raloxifene within six weeks of proposed start date 2. History of estrogen-sensitive tumor 3. Undiagnosed vaginal bleeding in the past 12 months 4. History of thromboembolic event 5. Currently have or have had liver problem 6. Bleeding disorder 7. Impaired mental status 8. Prior pelvic irradiation 9. Active vaginal infection 10. Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VSQ Score | Baseline, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VMI | 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. |
| Change in Vaginal pH | Baseline, Week 12 | Pelvic samples will be collected to test vaginal pH. |
| Change in VAS Score - Dyspareunia | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| Standard of Care Estrace: Vaginal estrogen cream, estradiol: 100mcg | 26 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Investigational | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 60 years | 59.75 years | 59.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 41 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 13 Participants | 33 Participants | 20 Participants |
| Region of Enrollment United States | 23 participants | 49 participants | 26 participants |
| Sex: Female, Male Female | 23 Participants | 49 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 8 / 22 | 8 / 23 |
| serious Total, serious adverse events | 0 / 22 | 1 / 23 |
Outcome results
Primary
Change in VSQ Score
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.
Time frame: Baseline, Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational | Change in VSQ Score | -3.3 score on a scale |
| Standard of Care | Change in VSQ Score | -3.7 score on a scale |
Secondary
Change in Vaginal pH
Pelvic samples will be collected to test vaginal pH.
Time frame: Baseline, Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational | Change in Vaginal pH | -0.2 pH units |
| Standard of Care | Change in Vaginal pH | -0.3 pH units |
Secondary
Change in VAS Score - Dyspareunia
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.
Time frame: Baseline, Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational | Change in VAS Score - Dyspareunia | -3 score on a scale |
| Standard of Care | Change in VAS Score - Dyspareunia | -3.6 score on a scale |
Secondary
Change in VMI
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.
Time frame: Baseline, Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational | Change in VMI | 4.4 Percentage of squamous cells |
| Standard of Care | Change in VMI | 38.4 Percentage of squamous cells |