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Assess Efficacy, Safety, and Tolerability of 8 Weeks of Vaginal Hyaluronic (V-HYAL) Gel in Peri- and Post-Menopausal Female

NCT06964646 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-05-09

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the efficacy of repeat doses of V-HYAL Gel on vaginal dryness in Peri- and Post-Menopausal Female. The main questions it aims to answer :

* To evaluate the effect of V-HYAL Gel on subjects' quality life.
* To evaluate the effect of V-HYAL Gel on the vaginal lactobacillus flora, vaginal thrush, bacterial vaginosis and trichomonas vaginalis
* To evaluate the safety and tolerability of repeat doses of V-HYAL Gel. Researchers will compare V-Hyal treated arm to see for its efficacy and safety.

Participants will have screening visit for the evaluation of subject's eligibility and three study days, Day 0 (Baseline), Week 4 (Telephone contact), and Week 8 (End of study visit). Primary criterion: Visual Analogic Scale (VAS) of vaginal dryness Secondary criterion: Vaginal microbiota and immunology HRQoL(SF 8), DIVA, FSFI questionnaires Patient Global Impression of Improvement Vaginal PH VHI scale.

Conditions

  • Vaginal Dryness

Interventions

DRUG

Vaginal Hyal gel 2.5g

vaginal gel 2.5g

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Hasniza Zaman Huri Prof, Doctor of Philosophy · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2024-06-27
Completion
2024-06-27

Countries

  • Malaysia

Study Locations

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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 NCT06964646 on ClinicalTrials.gov