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

Completed

• Conditions: Discomfort or pain during hysteroscopy; Signs and Symptoms

• Registration Number: ISRCTN46090514
• Lead Sponsor: Plethora Solutions Limited (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified