Effects of Single Dose Tadalafil on Urethral and Anal Closure Function and on Urinary Flow in Healthy Females: A Randomised, Controlled, Double-blinded, Two-period Cross-over Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Placebo-corrected change in opening urethral pressure after single dose tadalafil
研究概览
简要总结
The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The tadalafil tablets and placebo are over-encapsulated in identical hard-gelatin capsules. The over-encapsulation, packaging and labelling is performed by the hospital pharmacy.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form
- •Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
- •Sexual abstinence or use of safe contraceptive methods i.e. intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections), or surgically sterilized partner throughout the course of the study and until six days after the study has ended for the subject. Women who are postmenopausal (defined as no menstrual periods for 12 months or more prior to enrolment) can be included without use of contraceptive methods.
- •Presentation of a negative urine human chorionic gonadotropin (hCG) urine pregnancy test prior to dosing (on both study days)
排除标准
- •History of clinically significant urinary incontinence.
- •Current acute or chronic condition, unless considered clinically irrelevant and stable by the investigator.
- •Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening).
- •Average pulse < 40 or > 100 beats/minute (average of three measurements performed at screening).
- •Pregnancy within 6 months before screening and throughout the study period.
- •Breastfeeding throughout the study period and 6 days after study day
- •Any systemic drug use within 2 weeks before first study drug administration (prescription drugs, over-the-counter drugs, herbal drugs and illicit drugs), except for occasional use of paracetamol (up to 4 g/day), hormonal contraceptives and hormone replacement therapy.
- •Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months.
- •Alcohol consume 24 hours prior to dosing.
- •Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
研究组 & 干预措施
Tadalafil
Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2.
干预措施: Tadalafil 40 MG (Drug)
Placebo
Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Placebo-corrected change in opening urethral pressure after single dose tadalafil
时间窗: 2 hours post-dose
Difference in average urethral opening pressure (UOP) after administration of 40 mg tadalafil (UOP-tadalafil) compared to UOP after placebo (during relaxation).
次要结局
- Difference in average UOP-tadalafil and average UOP-placebo during squeezing.(2-hours post-dose)
- Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation).(2-hours post-dose)
- Difference in average AOP-tadalafil and average AOP-placebo during squeezing.(2-hours post-dose)
- Elastance (opening/closing) during relaxation and squeezing (tadalafil compared to placebo).(2-hours post-dose)
- Difference in maximum urine flow rate (Qmax) and average urine flow rate (Qave) after tadalafil and placebo administration, respectively.(2-hours post-dose)
研究者
Thea Christoffersen
Medical Doctor, Principal Investigator
University Hospital Bispebjerg and Frederiksberg