NCT02859285已完成不适用
Sexual Function in Postmenopausal Women: A Double Blinded, Randomized Pilot Study Evaluating the Effects of Topical Clitoral Estradiol Cream
ProHealth Care, Inc2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 19 point validated Female Function Index.
研究概览
简要总结
The purpose of this research study is to learn about sexual function in postmenopausal women and to determine whether the use of topical clitoral application of estradiol improves women's libido, arousal, and orgasmic ability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sexually active postmenopausal women of any age with complaint of vulvar and/or vaginal atrophy who also complain of bothersome decreased libido, and/or arousal, and/or orgasmic dysfunction
排除标准
- •Not sexually active with a partner or an arousal device
- •Uncontrolled diabetes as defined by having a consistent blood sugar level of over 100 mg/dL
- •Uncontrolled hypertension as defined by an average systolic blood pressure ≥140 mmHg or an average diastolic blood pressure ≥90 mmHg, among those with hypertension
- •Allergic to estradiol
- •Contraindications to estradiol such as undiagnosed abnormal genital bleeding; known/suspected or history of breast cancer; known/suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism; active or recent stroke or myocardial infarction; liver dysfunction or disease
- •Spanish speaking
结局指标
主要结局
19 point validated Female Function Index.
时间窗: Baseline then change over time at week 4,8,12
次要结局
- 36 point RAND health survey.(Baseline then change over time at week 4,8,12.)
研究者
研究点 (2)
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