NCT06964646

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Malaya · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary outcome: The primary outcome was the subjective performance evaluation in terms of the Visual Analogic Scale (VAS) for vaginal dryness was used as the primary criteria for determining the results of the trial. VAS was assessed at baseline (Day 0), during a telephone contact after the fifth administration, and at the final visit (week 8) after 19 administrations. VAS assessed are vaginal dryness, vaginal itching, vaginal irritation, and painful urination (0-10, 0 = absent, 10 = intolerable). Between-group differences in the proportion of patients with a reduction in VAS score at week 8, at p-value \< 0.05 significant. Secondary outcome: Criteria to be used as secondary outcomes are as follows: * High vaginal swab (HVS) to measure vagina lactobacillus flora, vaginal thrush, bacterial vaginosis and trichomonas vaginalis was done by taking a High Vaginal Swab (HVS) from the posterior fornix and observing the intensity and variety of microflora. * pH measurements were taken using pH strips. * Adverse events include any form of vaginal bleeding, bothersome vaginal irritations, bacterial vaginosis, vaginal yeast infection and hypersensitivity reactions. * Vaginal Health Index (VHI) (cut-off \< 15 index of atrophic vagina) and between-group difference in mean change from baseline to end of study (week 8) Female Sexual Function Index Scoring (FSFI) * Day-to-day Impact of Vaginal Aging Questionnaire (DIVA)

Conditions

• Vaginal Dryness

Interventions

Type	Name	Description
DRUG	Vaginal Hyal gel 2.5g	vaginal gel 2.5g

Timeline

• Start date: 2024-01-08
• Primary completion: 2024-06-27
• Completion: 2024-06-27
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: Malaysia