Status:
COMPLETED
Assess Efficacy, Safety, and Tolerability of 8 Weeks of Vaginal Hyaluronic (V-HYAL) Gel in Peri- and Post-Menopausal Female
Lead Sponsor:
University of Malaya
Conditions:
Vaginal Dryness
Eligibility:
FEMALE
45+ years
Phase:
PHASE4
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 th...
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 res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06964646
Start Date
January 8 2024
End Date
June 27 2024
Last Update
May 9 2025
Active Locations (1)
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1
Hospital Seberang Jaya
Seberang Jaya, Pulau Pinang, Malaysia, 14000