Vaginal Hyaluronic Acid, Arginine and Liposome Gel Versus Vaginal Lubricant in Postmenopausal Women With Genitourinary Syndrome of Menopause: A Prospective Double-blind Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- The change in VHI Questionnaire score
研究概览
简要总结
The goal of this interventional study is to compare the efficacy and safety of vaginal hyaluronic acid, arginine and liposome gel versus vaginal lubricant in the treatment of genitourinary syndrome of menopause in postmenopausal women. The main question it aims to answer is:
Is vaginal hyaluronic acid, arginine and liposome gel more effective than vaginal lubricant in the treatment of genitourinary syndrome of menopause in postmenopausal women
Participants will be randomized into 2 treatment groups: vaginal hyaluronic acid, arginine and liposome group and vaginal lubricant group.
Researchers will compare whether vaginal hyaluronic acid, arginine and liposome group has better improvement than vaginal lubricant group.
详细描述
Ethical conduct of the study
The study will be conducted in compliance with the protocol and clinical research center (CRC) standard operating procedures. These are designed to ensure adherence to the ethical principles that have their origin in the "World Medical Association Declaration of Helsinki" (see Appendix), "Malaysian Guidelines for Good Clinical Practice" and applicable regulatory Requirements.
Informed consent and subject information
Freely given informed consent will be obtained from every participant prior to participation in this study. The investigator will inform every participant in detail about the nature of the study, its purpose, the treatments and the random assignment to treatment groups, those aspects of the study that are experimental, the procedures involved including the reasonably expected benefits the expected duration and the approximate number of participants involved and the participant's responsibilities. Written consent will be obtained from each participant involved in the study by the investigators in Gynecology clinic, Department of Obstetric and Gynecology, Sarawak General Hospital. If the subject and his/her parent/guardian are unable to read, the investigator or designee must explain to the subject the content of the Patient Information Sheet and Consent Form point by point in the presence of an impartial witness. The witness should personally sign and date the consent form. The participant will be given the opportunity to ask questions and time for consideration. A copy of the Patient Information Sheet and signed Consent Form will be given to the participant . The original will be filed by the principal investigator in the Investigator's Study File.
Patient data protection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with GSM,
- •Postmenopause at least 1 year
- •40 to 80 years old
排除标准
- •Vaginal smear with atypical cell
- •The use of hormonal treatment/vaginal treatment in the previous 6 months
- •History of hormone-dependent tumor
- •Uninvestigated genital bleeding
- •Serious disease/ chronic condition that interferes with study compliance
研究组 & 干预措施
Arm 1
Arm 1 will apply 2.5 gram of VHAL gel intravaginally using vaginal applicator 2 times per week for 3 months
干预措施: Vaginal Gel (Drug)
Arm 2
Arm 2 will apply 2.5 gram of vaginal lubricant intravaginally using vaginal applicator 2 times per week for 3 months
干预措施: Vaginal lubricant (Drug)
结局指标
主要结局
The change in VHI Questionnaire score
时间窗: The change in VHI Questionnaire score is assessed at the baseline visit and at 12 weeks of vaginal gel/ vaginal lubricant application
Postmenopausal women with symptoms of genitourinary syndrome of menopause (GSM) will be asked to complete a questionnaire reporting their symptoms (vaginal pain, dyspareunia, vaginal dryness, burning, itching, and dysuria), and mark the severity of their symptoms on a 0-3 visual analogue scale (VAS). A score of 0 indicates the absence of a symptom, 1- mild , 2- moderate, 3-severe symptoms. We use the VHAL study questionnaire which is a modification of the validated vulvovaginal symptom questionnaire (VSQ-21).
The change in Vaginal Health Index (VHI)
时间窗: The change in Vaginal Health Index (VHI) is assessed at the baseline visit and at 12 weeks of vaginal gel/ vaginal lubricant application
The clinical evaluation will be performed by gynecologist blinded to the specific study-related information. The clinical data gathered included components of the Vaginal Health Index (VHI) score: elasticity, fluid secretion, potential of hydrogen (pH), epithelial mucosa integrity and moisture components. Each component is scored on a scale of 1 (worst) to 5 (best). The total score is 25 and lower scores indicate more severe atrophy. VHI will be calculated at baseline and 3 months after treatment.
The change in Vaginal Maturation Index (VMI)
时间窗: The change in Vaginal Maturation Index (VMI) is assessed at the baseline visit and at 12 weeks of vaginal gel/ vaginal lubricant application
Vaginal smear will be obtained from the upper one-third of the vagina using a spatula and stained according to the Papanicolaou technique at baseline and 3 months after treatment. The cytology samples will be fixed using alcohol and evaluated by an independent, blinded, board-certified pathologist from Department of Pathology, Sarawak General Hospital. The Vaginal Maturation Index (VMI) is determined by calculating the percentage of superficial, intermediate and parabasal epithelial cells on the smear by using this formula \[(1 ×%superficial) + (0.5 × %intermediate) + (0 × %parabasal)\]. The vaginal smear will be destroyed 3 months after the completion of study and will not be used for future study.
次要结局
- Side effects of VHAL gel and vaginal lubricant(The side effects are assessed at the baseline visit and at 12 weeks of vaginal gel/ vaginal lubricant application)
研究者
Jun Jiet Ng
Obstetrician and Gynecologist, Principal investigator
Sarawak General Hospital