Female Sexual Dysfunction in the Menopause: Effect of Intranasal Oxytocin Administration on Sexual Function and Activity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Female Sexual Function
研究概览
简要总结
The purpose of this study is to determine whether intranasal oxytocin is effective in comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willingness to attempt sexual intercourse and/ or masturbation at least two times per week
- •Ongoing relationship for at least 3 months
- •Female subjects aging 40 years and more, Male subjects must be older than 18
- •The participation in this study should be of free choice to male partners
- •Willingness to perform a pregnancy test every month (for pre-menopausal subjects)
- •Willingness to use contraception during the study period (for pre-menopausal subjects)
- •Normal findings in the urogenital tract unless the investigator considers an abnormality to be clinically irrelevant
- •Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
排除标准
- •Primary sexual dysfunction
- •sexual abuse
- •severe psychiatric diseases
- •untreated conditions and medication intake with associated reduction of sexual function.
- •In male partners: any severe andrological or related medical problem.
研究组 & 干预措施
Syntocinon Nasalspray 32 IU
Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
干预措施: Syntocinon Nasalspray (Drug)
Syntocinon Nasalspray 32 IU
Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
干预措施: Placebo Nasalspray (Drug)
Placebo Nasalspray
Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
干预措施: Syntocinon Nasalspray (Drug)
Placebo Nasalspray
Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
干预措施: Placebo Nasalspray (Drug)
结局指标
主要结局
Female Sexual Function
时间窗: 22 weeks
Assessment by standardized questionnaires including Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Activity Record (SAR), and Sexual Interest and Desire Inventory-Female (SIDI-F).
次要结局
- Hamilton Depression Scale (HDS)(22 weeks)
研究者
Dana Muin
Univ. Prof. Michaela Bayerle-Eder
Medical University of Vienna