A Phase 4 interventional study of Vaginal Hyal gel 2.5g in Vaginal Dryness, sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by University of Malaya · Phase 4, Interventional, and Treatment
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 :
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.
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:
University of Malaya is the lead sponsor of 282 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Given 2.5g of Vaginal Hyal gel
Drug: Vaginal Hyal gel 2.5g
No intervention control group
vaginal gel 2.5g
Visual Analogic Scale (VAS)
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 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.
Time frame: . VAS was assessed at baseline (Day 0), during a telephone contact after the fifth administration (Week 4), and at the final visit (week 8) after 19 administrations.
High Vaginal Swab
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
Time frame: 8 weeks
Vaginal pH
pH measurements were taken using pH strips before and after using the investigational product
Time frame: 8 weeks
Vaginal Health Index
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)
Time frame: 8 weeks
Female Sexual Function Index Scoring (FSFI)
Female Sexual Function Index Scoring (FSFI) between-group difference in mean change from baseline to end of study (week 8) The Female Sexual Function Index (FSFI) is a standardized, 19-item questionnaire used to assess sexual function in women across six key domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain includes a specific number of questions with responses scored on a Likert scale, typically ranging from 0 or 1 to 5. Domain scores are calculated by summing the scores of the relevant questions and multiplying by a domain-specific factor: desire (×0.6), arousal (×0.3), lubrication (×0.3), orgasm (×0.4), satisfaction (×0.4), and pain (×0.4). The total FSFI score is the sum of these six domain scores, with a maximum possible score of 36. A total score of 26.55 or lower is generally considered indicative of female sexual dysfunction.
Time frame: 8 weeks
Day-to-day Impact of Vaginal Aging (DIVA)
The DIVA questionnaire includes 23 items distributed across four domains: daily activities (5 items), emotional well-being (4 items), sexual functioning (9 items), and self-concept/body image (5 items). Each item is rated on a 5-point Likert scale from 1 (no impact) to 5 (very severe impact), with higher scores indicating greater negative impact. For each domain, the scores of individual items are averaged to produce a mean domain score, rather than summed, ensuring comparability across domains with different numbers of items.
Time frame: 8 weeks
Plan to share: No
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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