An investigation of the feasibility of using a topical formulation of lidocaine (SHACT) for hysteroscopy in women.

Phase 1

• Conditions: Investigating the feasibility of using a topical formulation.; MedDRA version: 16.0Level: PTClassification code 10064882Term: Procedural painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2013-001775-20-SE
• Lead Sponsor: Pharmanest AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-07
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

•Patients planned for hysteroscopy under anaesthesia at Kvinnokliniken, Södersjukhuset
•Has given written informed consent after verbal and written information

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

•Contraindication for hysteroscopy with lidocaine instillation at the discretion of the principal investigator
•Known allergy to lidocaine
•Recidivating porphyria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified