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Vaginal Hyaluronic Acid, Arginine and Liposome Gel Versus Vaginal Lubricant in Postmenopausal Women With Genitourinary Syndrome of Menopause

NCT06176820 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-12-28

No results posted yet for this study

Summary

The goal of this interventional study is to compare the efficacy and safety of vaginal hyaluronic acid, arginine and liposome gel versus vaginal lubricant in the treatment of genitourinary syndrome of menopause in postmenopausal women. The main question it aims to answer is:

Is vaginal hyaluronic acid, arginine and liposome gel more effective than vaginal lubricant in the treatment of genitourinary syndrome of menopause in postmenopausal women

Participants will be randomized into 2 treatment groups: vaginal hyaluronic acid, arginine and liposome group and vaginal lubricant group.

Researchers will compare whether vaginal hyaluronic acid, arginine and liposome group has better improvement than vaginal lubricant group.

Conditions

  • Menopause Related Conditions
  • Atrophic Vaginitis
  • Genitourinary Syndrome of Menopause
  • Sexual Dysfunction

Interventions

DRUG

Vaginal Gel

Arm 1 will apply 2.5 gram of VHAL gel intravaginally using vaginal applicator 2 times per week for 3 months

DRUG

Vaginal lubricant

Arm 2 will apply 2.5 gram of vaginal lubricant intravaginally using vaginal applicator 2 times per week for 3 months

Sponsors & Collaborators

  • Sarawak General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-07-01
Completion
2024-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06176820 on ClinicalTrials.gov