Role of Topical Oxytocin Gel On Vaginal Atrophy, Psycho-sexual and Psychological Function and Metabolic and Inflammatory Parameters in Post-Menopausal Egyptian Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cholesterol
研究概览
简要总结
Aim of the current study:
To evaluate the effect of a14 day treatment period with local intravaginal application of an oxytocin-containing gel on vaginal atrophy, psychosexual and psychological/cognitive function, and metabolic, stress, and inflammatory parameters in Egyptian post-menopausal women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 47 Years 至 66 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The women were post-menopausal and were between 47 and 67 years old
- •The women's last menstruation had occurred more than one year prior to the study
- •The women had an established vaginal atrophy
- •The women scored < 26 in the Female Sexual Function Index (FSFI)
- •The women had an active sexual relationship
排除标准
- •Women who smoked
- •Women who used hormone replacement therapy
- •Women using a vaginal lubricant
- •Women having any vaginal bleeding or any breast diseases
- •Women having any undiagnosed genitalia disorder
- •Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular disease, or psychiatric disease
结局指标
主要结局
Cholesterol
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
HBA1C
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
C-Peptide F
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
intravaginal potential of hydrogen (pH)
时间窗: by the end of 14 successive days of regular use
Intravaginal pH was measured by a litmus paper applied intravaginally
Cytological examination of vaginal smear
时间窗: by the end of 14 successive days of regular use
A piece of cotton was applied on a stick ( a vaginal swab) to the posterior vaginal wall to collect material from the epithelium
LDL-C
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
Cortisol at morning
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
Triglyceride
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
HDL-C
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
C-Reactive Protein (CRP)
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
Random blood sugar (RBS)
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
Insulin
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
The Female Sexual Function Index (FSFI) questionnaire
时间窗: by the end of 14 successive days of regular use
19 questions to measure sexual function in six domains, including sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. We applied the modified FSFI, which included 6 questions to measure sexual function in the six domains (one question for each). The score for each domain is evaluated by six levels (from 0 to 6); the lowest is 0, and the maximum is 6. The sexual function was assessed by the sum of all 6 domains.
vaginal pallor
时间窗: by the end of 14 successive days of regular use
A vaginal inspection was performed to establish the presence of vaginal pallor
Visual Analogue Scale (VAS)
时间窗: by the end of 14 successive days of regular use
to assess the severity of the vaginal pain if present. The score ranges from 0 if no pain to 10 for the severest degree of pain.
questionnaire to assess the psychological function
时间窗: by the end of 14 successive days of regular use
It consisted of 6 domains, including social cognition, memory, social trust, prosocial behavior, aggressive behavior, and depression, which included 2 questions for memory and depression and one question for social cognition, social trust, prosocial behavior, and aggressive behavior. The score for each domain is evaluated by 4 levels (from 0 to 3), the lowest is 0, and the maximum is 3. The psychological function was assessed by the sum of all domains.
Tumor necrosis factor-Alfa (TNF-Alfa)
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
Interleukin-6 (IL-6)
时间窗: by the end of 14 successive days of regular use
to assess the serum level in both groups
次要结局
未报告次要终点
研究者
Asem Anwar Moussa
Professor
Al-Azhar University