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

• Register: EUCTR
• Last refreshed on: 2 June 2020
• Main ID: EUCTR2013-001775-20-SE
• Date of registration: 07/05/2013
• Prospective Registration: Yes
• Primary sponsor: Pharmanest AB
• Public title: An investigation of the feasibility of using a topical formulation of lidocaine (SHACT) for hysteroscopy in women.
• Scientific title: A phase 2 study investigating the feasibility of using a topical formulation of lidocaine (SHACT) for hysteroscopy in women.
• Date of first enrolment: 07/06/2013
• Target sample size: 10
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001775-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: Double blind: Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Sweden

Contacts

• Name: Medical Advisor
• Affiliation: Pharamanest

• Name: Medical Advisor
• Affiliation: Pharamanest

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Investigating the feasibility of using a topical formulation.
MedDRA version: 16.0 Level: PT Classification code 10064882 Term: Procedural pain System Organ Class: 10022117 - Injury, poisoning and procedural complications

Intervention(s)

Product Name: SHACT
Product Code: SHACT
Pharmaceutical Form: Vaginal solution
INN or Proposed INN: lidocain
CAS Number: 137-58-6
Current Sponsor code: SHACT
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 4-

Primary Outcome(s)

Primary end point(s): No specific endpoint as this is a feasability study

Main Objective: To obtain initial information regarding the feasibility of using SHACT as a formulation for hysteroscopy

Secondary Objective: •To evaluate the handling properties of SHACT and its instillation device
•To evaluate the instructions for Use at hysteroscopy
•To obtain information about safety and tolerability of SHACT

Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

PH-HYS-01

Source(s) of Monetary Support

Pharmanest AB

Ethics review

Status: Approved
Approval date: 04/06/2013
Contact: