Back to resultsEvaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause
Primary Purpose
Menopause Syndrome
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vaginal Moisturizing Gel
Sponsored by
About this trial
This is an interventional treatment trial for Menopause Syndrome
Eligibility Criteria
Subjects who have the relevant syndromes of vulvovaginal atrophy, and who are
- In the status of menopause (≥12 months after the last menstrual cycle); or
- FSH > 40 mIU/ml and estradiol level < 20 pg/ml; or
- bilateral ovary resection; or
- the patients, i.e. breast cancer patients, who completed cancer therapy
Subjects have self-identified at least one of mild to moderate or severe symptoms listed below that are the most bothersome to her.
- Vaginal dryness
- Vaginal and/or vulvar irritation/itching
- Dysuria
- Vaginal pain associated with sexual activity
- Vaginal bleeding associated with sexual activity
- Subjects are willing to comply with all aspects of the study and have signed informed consent form.
Exclusion Criteria:
- Subjects have been diagnosed with cervical or vaginal malignant neoplasms
- Subjects with abnormal undiagnostic genital bleeding
- Subject with active vaginal infection
- Subjects with vaginal pH value < 4.5
- Subjects are under hormone replacement therapy within three months
- Subjects are under phytoestrogen treatment within two month
- Subjects use of vaginal douche, lubricant or moisturizer in one week
- Subjects are hypersensitive to sodium hyaluronate, carrageenan
Sites / Locations
- Changhua Christian Hospital
- China Medical University Hospital
- Chi Mei Medical Center
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Treatment duration: 8 weeks Twice treatments per week
Outcomes
Primary Outcome Measures
pH value change
The change of the vaginal pH value
Secondary Outcome Measures
The Questionnaire of Genitourinary Syndromes of Menopause
The change of its severity is used to evaluate symptomatic improvement. The minimum value is 0 and maximum value is 3, where higher scores mean a worse outcome.
Vaginal maturation index (VMI)
The change of its value is used to evaluate the maturation of the vaginal epithelial cells
Full Information
NCT ID
NCT05263102
First Posted
February 21, 2022
Last Updated
December 30, 2022
Sponsor
HAN Biomedical Inc
1. Study Identification
Unique Protocol Identification Number
NCT05263102
Brief Title
Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause
Official Title
Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
August 13, 2022 (Actual)
Study Completion Date
August 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HAN Biomedical Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the safety and efficacy of the vaginal gel with HMW HA in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovarian or breast cancer diagnosis and treatment.
Detailed Description
It was recognized that GSM is likely to be underdiagnosed and undertreated9. The North American Menopause Society (NAMS) issued the treatment guideline of GSM in 2014 and encouraged the physicians and nurses to pursue menopausal women to check if they have genitourinary syndrome. GSM is considered a progressive condition in menopausal women, and the primary goal of treatment strategy is symptom relief. Options include lifestyle changes, non-hormonal, and hormonal treatments. Hormonal therapies include both topical and systemic approaches. However, many women reported that substantial concerns about the long-term safety of hormonal products.The patients are aware of the possible relationship between cancer, heart disease, stroke, and estrogen-based treatments10. For considering long-term treatment strategy, estrogen free products of vaginal lubricant or vaginal moisturizer are recommended as first line treatment for those with mild to moderate syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
before and after treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Treatment duration: 8 weeks Twice treatments per week
Intervention Type
Device
Intervention Name(s)
Vaginal Moisturizing Gel
Intervention Description
All eligible subjects will received the Vaginal Moisturizing Gel twice per week, total in 8 weeks
Primary Outcome Measure Information:
Title
pH value change
Description
The change of the vaginal pH value
Time Frame
from baseline to week 8
Secondary Outcome Measure Information:
Title
The Questionnaire of Genitourinary Syndromes of Menopause
Description
The change of its severity is used to evaluate symptomatic improvement. The minimum value is 0 and maximum value is 3, where higher scores mean a worse outcome.
Time Frame
from baseline to week 8
Title
Vaginal maturation index (VMI)
Description
The change of its value is used to evaluate the maturation of the vaginal epithelial cells
Time Frame
from baseline to week 8
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who suffer genitourinary syndrome of Menopause
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects who have the relevant syndromes of vulvovaginal atrophy, and who are
In the status of menopause (≥12 months after the last menstrual cycle); or
FSH > 40 mIU/ml and estradiol level < 20 pg/ml; or
bilateral ovary resection; or
the patients, i.e. breast cancer patients, who completed cancer therapy
Subjects have self-identified at least one of mild to moderate or severe symptoms listed below that are the most bothersome to her.
Vaginal dryness
Vaginal and/or vulvar irritation/itching
Dysuria
Vaginal pain associated with sexual activity
Vaginal bleeding associated with sexual activity
Subjects are willing to comply with all aspects of the study and have signed informed consent form.
Exclusion Criteria:
Subjects have been diagnosed with cervical or vaginal malignant neoplasms
Subjects with abnormal undiagnostic genital bleeding
Subject with active vaginal infection
Subjects with vaginal pH value < 4.5
Subjects are under hormone replacement therapy within three months
Subjects are under phytoestrogen treatment within two month
Subjects use of vaginal douche, lubricant or moisturizer in one week
Subjects are hypersensitive to sodium hyaluronate, carrageenan
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua city
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause
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