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

What this trial studies

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.

Conditions in scope

• Vaginal Dryness

Interventions

• Vaginal Hyal gel 2.5g (Drug) — vaginal gel 2.5g

Who can join

Women only · Ages 45 Years and up

Inclusion criteria

• 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

Exclusion criteria

• 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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE4
• Start date: 2024-01-08
• Primary completion: 2024-06-27
• Last update posted: 2025-05-09
• First posted: 2025-05-09

Sponsor & contact

Lead sponsor: University of Malaya (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Visual Analogic Scale (VAS) (. 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.)
  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…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.