A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women With Vaginal Atrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Oxytocin plasma levels
研究概览
简要总结
This study aims to evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70 years old with vaginal atrophy will be included and will self-administer Vagitocin intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours, relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic variables will be calculated. The % of oxytocin which was absorbed following vaginal administration (bioavailability)will also be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Post-menopausal women with vaginal atrophy as judged by the investigator
- •Willing to participate in the study as indicated by signing the informed consent
- •Healthy post-menopausal women between the ages of 40 and 70 years, inclusive
- •Body mass index (BMI) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2
- •Judged by the Investigator to be healthy on the basis of medical evaluation
排除标准
- •Hospitalized subjects
- •Symptoms of any significant acute illnesses at the screening visit
- •History of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product)
- •Known history of sensitivity to oxytocin or related derivatives
- •Follicle-stimulating hormone level < 40 pmol/mL
- •Known history of narcotic addiction, drug abuse or alcoholism
- •Simultaneously participate in another clinical study
- •Use of any sex steroids including phytoestrogens, hormonal intrauterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline
- •Uncontrolled hypertension and/or hypercholesterolemia
研究组 & 干预措施
Vagitocin (Oxytocin)
干预措施: Vagitocin (Drug)
结局指标
主要结局
Oxytocin plasma levels
时间窗: Day 1 to 26
Oxytocin plasma levels after intravaginal and intravenous administration
次要结局
未报告次要终点