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

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.

Study Overview

• Status: Completed
• Conditions: Menopause Syndrome
• Intervention / Treatment: Device: Vaginal Moisturizing Gel

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua city, Taiwan
    • Changhua Christian Hospital
  • Taichung, Taiwan
    • China Medical University Hospital
  • Tainan, Taiwan
    • Chi Mei Medical Center
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

1. Subjects who have the relevant syndromes of vulvovaginal atrophy, and who are

   1. In the status of menopause (≥12 months after the last menstrual cycle); or
   2. FSH > 40 mIU/ml and estradiol level < 20 pg/ml; or
   3. bilateral ovary resection; or
   4. the patients, i.e. breast cancer patients, who completed cancer therapy

2. Subjects have self-identified at least one of mild to moderate or severe symptoms listed below that are the most bothersome to her.

   1. Vaginal dryness
   2. Vaginal and/or vulvar irritation/itching
   3. Dysuria
   4. Vaginal pain associated with sexual activity
   5. Vaginal bleeding associated with sexual activity
3. Subjects are willing to comply with all aspects of the study and have signed informed consent form.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Treatment duration: 8 weeks Twice treatments per week	Device: Vaginal Moisturizing Gel; All eligible subjects will received the Vaginal Moisturizing Gel twice per week, total in 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH value change	The change of the vaginal pH value	from baseline to week 8

Secondary Outcome Measures

Outcome Measure	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)	The change of its value is used to evaluate the maturation of the vaginal epithelial cells	from baseline to week 8

Collaborators and Investigators

• Sponsor: HAN Biomedical Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): August 13, 2022
• Study Completion (Actual): August 13, 2022

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: HAN2014005-CT02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No