A phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to compare the efficacy, safety and tolerability of PSD502, delivered topically onto the upper vagina and cervix, to placebo in controlling discomfort/pain intensity in subjects undergoing outpatient hysteroscopy

Plethora Solutions Limited (UK)0 个研究点目标入组 24 人开始时间: 2008年2月13日最近更新: 2015年1月13日

试验速览

暂无简介。

•A subject will be invited to participate if she meets the following inclusion criteria:
•1. Healthy, pre-menopausal female who requires hysteroscopy
•2. Aged 18 - 50 years inclusive
•3. Clinically insignificant medical history and clinical examination other than the underlying condition requiring treatment, in the opinion of the Investigator
•4. Post menstruation, but prior to ovulation at the time of the procedure and has a negative pregnancy test
•5. Able to understand and complete the visual analogue pain scale (VAPS) and 4-point discomfort/pain scale, in the opinion of the Investigator
•6. Willing and able to provide written informed consent

•A subject will be excluded from study participation if she meets any of the following criteria:
•1. Contraindication to hysteroscopy
•2. Known hypersensitivity to amide-type local anaesthetics
•3. Received another investigational product within the previous 3 months
•4. Current history of alcohol or drug abuse such that the subject is unable to comply with the study procedures or has resulting clinically significant organ damage, in the opinion of the Investigator
•5. Clinically-significant medical history or clinical finding (e.g. bleeding diathesis or coagulopathy) that would affect the subject's ability to take part in the study, in the opinion of the Investigator
•6. Previous hysteroscopy with technical difficulties or side effects
•7. Used lidocaine or prilocaine preparation within 6 hours before the hysteroscopy procedure

发起方

Plethora Solutions Limited (UK)