NCT05263102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2022

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

2.5 years

First QC Date

February 21, 2022

Last Update Submit

December 30, 2022

Conditions

Menopause Syndrome

Outcome Measures

Primary Outcomes (1)

  • pH value change

    The change of the vaginal pH value

    from baseline to week 8

Secondary Outcomes (2)

  • The Questionnaire of Genitourinary Syndromes of Menopause

    from baseline to week 8

  • Vaginal maturation index (VMI)

    from baseline to week 8

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Treatment duration: 8 weeks Twice treatments per week

Device: Vaginal Moisturizing Gel

Interventions

Vaginal Moisturizing GelDEVICE

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

Treatment Arm

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who suffer genitourinary syndrome of Menopause
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Changhua Christian Hospital

Changhua, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Chi Mei Medical Center

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: before and after treatment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

March 1, 2020

Primary Completion

August 13, 2022

Study Completion

August 13, 2022

Last Updated

January 3, 2023

Record last verified: 2022-12

Locations

TW(4)