Assess Efficacy, Safety, and Tolerability of 8 Weeks of Vaginal Hyaluronic (V-HYAL) Gel in Peri- … (NCT06964646) | Clinical Trial Compass
CompletedPhase 4
Assess Efficacy, Safety, and Tolerability of 8 Weeks of Vaginal Hyaluronic (V-HYAL) Gel in Peri- and Post-Menopausal Female
Malaysia70 participantsStarted 2024-01-08
Plain-language 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.
Who can participate
Age range45 Years
SexFEMALE
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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.
What they're measuring
1
Visual Analogic Scale (VAS)
Timeframe: . 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.
✕. 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.