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

Not Applicable

Completed

• Conditions: Menopause Syndrome
• Interventions: Device: Vaginal Moisturizing Gel

• Registration Number: NCT05263102
• Lead Sponsor: HAN Biomedical Inc

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Primary Completion: 2022-08-13
• Study Completion: 2022-08-13
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects have been diagnosed with cervical or vaginal malignant neoplasms
2. Subjects with abnormal undiagnostic genital bleeding
3. Subject with active vaginal infection
4. Subjects with vaginal pH value < 4.5
5. Subjects are under hormone replacement therapy within three months
6. Subjects are under phytoestrogen treatment within two month
7. Subjects use of vaginal douche, lubricant or moisturizer in one week
8. Subjects are hypersensitive to sodium hyaluronate, carrageenan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Vaginal Moisturizing Gel	Treatment duration: 8 weeks Twice treatments per week

Primary Outcome Measures

Name	Time	Method
pH value change	from baseline to week 8	The change of the vaginal pH value

Secondary Outcome Measures

Name	Time	Method
Vaginal maturation index (VMI)	from baseline to week 8	The change of its value is used to evaluate the maturation of the vaginal epithelial cells
The Questionnaire of Genitourinary Syndromes of Menopause	from baseline to week 8	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.

Trial Locations

Locations (4)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Changhua Christian Hospital; 🇨🇳 Changhua city, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Chi Mei Medical Center; 🇨🇳 Tainan, Taiwan