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| Name | Class |
|---|---|
| JDS Therapeutics, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revaree | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lila Nachtigall, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39042017 | Derived | Agrawal S, LaPier Z, Nagpal S, Oot A, Friedman S, Hade EM, Nachtigall L, Brucker BM, Escobar C. A randomized, pilot trial comparing vaginal hyaluronic acid to vaginal estrogen for the treatment of genitourinary syndrome of menopause. Menopause. 2024 Sep 1;31(9):750-755. doi: 10.1097/GME.0000000000002390. Epub 2024 Jul 20. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
The data will be become available beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data upon reasonable request. Requests should be directed to Surbhi.agrawal@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2022 |
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| Estrace | Drug | Vaginal estrogen cream, estradiol: 100mcg |
|
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| Change in Vaginal pH | Pelvic samples will be collected to test vaginal pH. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| Standard of Care |
Estrace: Vaginal estrogen cream, estradiol: 100mcg |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard of Care | Estrace: Vaginal estrogen cream, estradiol: 100mcg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 12 |
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| 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. | Posted | Mean | 95% Confidence Interval | Percentage of squamous cells | Baseline, Week 12 |
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| Secondary | Change in Vaginal pH | Pelvic samples will be collected to test vaginal pH. | Posted | Mean | 95% Confidence Interval | pH units | Baseline, Week 12 |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 12 |
|
|
12 Weeks
Self-reporting by participants at any point during study or at follow up visit when asked
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 22 | 0 | 22 | 8 | 22 |
| EG001 | Standard of Care | Estrace: Vaginal estrogen cream, estradiol: 100mcg | 0 | 23 | 1 | 23 | 8 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure/syncope | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Vulvovaginal candidasis | Infections and infestations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Abdominal cramping | Gastrointestinal disorders | Non-systematic Assessment |
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| Tingling in finger | Nervous system disorders | Non-systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vaginal odor | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vaginal discomfort | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vaginal burning sensation | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vaginal irritation | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vulvar itching | Reproductive system and breast disorders | Non-systematic Assessment |
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| Worsening of preexisting condition | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pelvic heaviness | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lila Nachtigall | NYU Langone Health | 2122636361 | Lila.Nachtigall@nyulangone.org |
| Sep 19, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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