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

niversity hospital Bispebjerg and Frederiksberg, Department of Clinical Pharmacology0 个研究点目标入组 24 人开始时间: 2021年1月8日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•Female between 18 and 55 years old (both included)
•Signed informed consent form
•Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
•Use of safe contraceptive methods throughout the course of the study
•i.e. intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections) through the entire trial and until six days after the study has ended for the subject. Subjects who are postmenopausal (defined as no menses for 12 months or more prior enrolment) can be included without use of contraceptive products.
•Presentation of a negative urine human chorionic gonadotropin (hCG) urine pregnancy test prior to dosing (on both study days)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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
•Breastfeeding within 3 months before screening
•Any 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) within 3 months before screening
•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)

发起方

niversity hospital Bispebjerg and Frederiksberg, Department of Clinical Pharmacology