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

A phase 2 study investigating the feasibility of using a topical formulation of lidocaine (SHACT) for hysteroscopy in women.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001775-20-SE

Enrollment

Registered

2013-05-07

Start date

2013-06-07

Completion date

Unknown

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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/

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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;Primary end point(s): No specific endpoint as this is a feasability study;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

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;Primary end point(s): No specific endpoint as this is a feasability study;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactMedical Advisor

Pharamanest

gunvor.ekman-ordeberg@ki.se+4670 6083111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026