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

NCT06964646 | Completed Phase 4

• 2 other identifiers: VDMEN-V4.0-2023NMRR ID-23-02085-IH7
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  . 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.

Secondary Outcomes (5)

• High Vaginal Swab

  8 weeks

• Vaginal pH

  8 weeks

• Vaginal Health Index

  8 weeks

• Female Sexual Function Index Scoring (FSFI)

  8 weeks

• Day-to-day Impact of Vaginal Aging (DIVA)

  8 weeks

Study Arms (2)

Intervention Group (with V-HYAL Gel (formerly Vaginal Hyal Gel))

EXPERIMENTAL

Given 2.5g of Vaginal Hyal gel

Drug: Vaginal Hyal gel 2.5g

Control group

NO INTERVENTION

No intervention control group

Interventions

Vaginal Hyal gel 2.5g DRUG

vaginal gel 2.5g

Intervention Group (with V-HYAL Gel (formerly Vaginal Hyal Gel))

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: The study is specific to the biological female sex as it involves female reproductive organ
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peri or post-menopausal.
• BMI between 18 kg/m2 and 30 kg/m2.
• Able to give written informed consent before starting any study-related procedure.
• Medical history and physical examination normal or abnormal but not clinically relevant on the investigator judgment.
• ECG tracing, blood pressure and laboratory tests within normal range or abnormal but not clinically relevant as per the investigator's judgment.
• Not under any administrative or legal supervision.
• Sexually active in the last three months

You may not qualify if:

• Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
• Inability or unwillingness to provide written consent.
• Pregnancy, breastfeeding, or use of nonreliable methods of contraception.
• Other medical conditions which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
• History or evidence of allergy, idiosyncrasy or hypersensitivity to hyaluronic acid.
• History or clinical evidence of significant or uncontrolled cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal, haematological, neurological or psychiatric pathology which may affect the study outcomes.
• Chronic diseases such as HIV I and II, HBV and HCV surgery within previous 6 months, or blood loss \> 400 mL within previous 3 months.
• History of alcohol or drug abuse.
• Took hormone therapy or tibolone in the 3 months before the first dosing occasion and during the study.
• Took any pharmacological treatment which may affect the vaginal dryness or study outcomes, such as Menopausal Hormone Therapy (except for symptomatic short-term paracetamol use)
• Received concomitant treatment with other investigational drugs or had participated in another clinical trial within the previous 6 months prior to dosing / 4 weeks prior to screening visit.
• Had any surgery or medical treatment which may interfere with study outcomes (i.e. hysterectomy).
• Any subject who cannot be contacted in case of emergency.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, 14000, Malaysia

Location

Related Publications (1)

• Chen J, Geng L, Song X, Li H, Giordan N, Liao Q. Evaluation of the efficacy and safety of hyaluronic acid vaginal gel to ease vaginal dryness: a multicenter, randomized, controlled, open-label, parallel-group, clinical trial. J Sex Med. 2013 Jun;10(6):1575-84. doi: 10.1111/jsm.12125. Epub 2013 Apr 9.

  PMID: 23574713 BACKGROUND

Study Officials

• Hasniza Zaman Huri Prof, Doctor of Philosophy

  University of Malaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group received repeat doses of 2.5g of V-HYAL Gel® (formerly Vaginal Hyal Gel) every three days, while the control group did not receive the gel.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 9, 2025
• Study Start: January 8, 2024
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)