Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Comparison of vaginal cytology test for vaginal maturation index measurement
研究概览
简要总结
Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it. But it may increase the risk of breast and endometrial cancer. The oxytocin hormone also promotes positive social behavior, stress regulation, and female sexual arousal. Many previous studies show that topical oxytocin is useful for reducing vaginal atrophy in postmenopausal women.
详细描述
Random and conducted on 56 postmenopausal women who meet the inclusion criteria and excluded participants that have exclusion criteria. All women provided written informed consent before data collection.
- st Visit: The vagina was assessed regarding infection and any abnormal discharge. The participants were evaluated vaginal signs of vaginal atrophy by per vaginal examination and assessed vaginal health index score. The subjective symptoms were assessed by The most bothersome score. The vaginal pH was tested with a Nitrazine paper. The vaginal swab was done and the specimen was sent for a cytological test - vaginal maturation index evaluation (VMI). The participants were separated into two groups 1. Oxytocin gel group and 2. Placebo gel group then applied gel 1 ml. (400IU of oxytocin in oxytocin gel) per day for 8 weeks consecutively. The subjective symptoms were assessed at 2 and 4 weeks by phone.
- nd Visit: The participants were assessed the same as 1st visit that recorded vaginal health index score, subjective symptoms, vaginal pH, and vaginal maturation index evaluation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Thai menopausal women aged between 50-70 years who visit Rajavithi gynecology OPD with informed consent with good communication in the Thai language.
排除标准
- •Have acute vulvovaginitis (vaginal swab for wet smear and KOH)
- •Patients who have used hormonal replacement therapy within 12 months
- •Patients with a history of smoking
- •Patients who have used vaginal lubricant or moisturizer
- •Patients with an allergic history of oxytocin or gel components
- •Morbid obesity BMI > 30 kg/m2
- •Patients who have used vitamin E supplement
- •Patients who unable to perform per vaginal examination
研究组 & 干预措施
Oxytocin gel
Oxytocin gel 400IU per 1 ml (on HPMC 4,000 cps base gel), applied at vaginal canal 1 ml per day for 8 weeks
干预措施: Oxytocin (Drug)
Placebo gel
Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of vaginal cytology test for vaginal maturation index measurement
时间窗: Change from baseline VMI at 8 weeks
VMI = 0.2 × % parabasal cells+0.6 × % intermediate cells+1.0 × % superficial cells score below 52 mean significant vulvovaginal atrophy
次要结局
- Comparison of adverse events between two group(adverse events within 8 weeks)
- Comparison of vaginal pH between two group(Vaginal pH at 8 weeks)
- Comparison of subjective symptoms by The most bothersome symptoms score(Change from baseline subjective symptom score at 8 weeks)
- Comparison of vaginal health index; scoring from vaginal examination(Change from baseline vaginal health index score at 8 weeks)