NCT05263102

Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: HAN Biomedical Inc · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause Syndrome

Interventions

Type	Name	Description
DEVICE	Vaginal Moisturizing Gel	All eligible subjects will received the Vaginal Moisturizing Gel twice per week, total in 8 weeks

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-08-13
• Completion: 2022-08-13
• First posted: 2022-03-02
• Last updated: 2023-01-03

Locations

4 sites across 1 country: Taiwan