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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Treatment duration: 8 weeks Twice treatments per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Moisturizing Gel | Device | All eligible subjects will received the Vaginal Moisturizing Gel twice per week, total in 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| pH value change | The change of the vaginal pH value | from baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to week 8 |
| Vaginal maturation index (VMI) |
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Subjects who have the relevant syndromes of vulvovaginal atrophy, and who are
Subjects have self-identified at least one of mild to moderate or severe symptoms listed below that are the most bothersome to her.
Subjects are willing to comply with all aspects of the study and have signed informed consent form.
Exclusion Criteria:
Women who suffer genitourinary syndrome of Menopause
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Taiwan | ||||
| China Medical University Hospital |
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before and after treatment
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The change of its value is used to evaluate the maturation of the vaginal epithelial cells |
| from baseline to week 8 |
| Taichung |
| Taiwan |
| Chi Mei Medical Center | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |