An open label pharmcokinetic study of a topical formulation of lidocaine (SHACT) for pain relief in women receiving an Intra Uterine Device.

Phase 1

• Conditions: Pain during insertion of an intra uterine device; MedDRA version: 14.1Level: PTClassification code 10064882Term: Procedural painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-005660-18-SE
• Lead Sponsor: Pharmanest AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-27
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

•Wish for IUD insertion
•Minimum 18 years of age
•a) If patient has regular periods, she must be in menstrual cycle day 2-6 at insertion.

b) If patient has no or small irregular bleedings due to hormonal contraception, the insertion may take place at any convenient day

•Able to understand Swedish well enough to be familiar with all study procedures
•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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Clinical evidence of or ongoing treatment for active cervical infection
•Positive pregnancy test
•Pelvic inflammation disease in the last month
•History of uterine conisation
•Known uterine anomaly that contradict IUD insertion
•Copper allergy/Wilson’s disease
•Cervical or uterine cancer
•Known allergy to lidocaine
•Intolerance to paracetamol (rescue medication)
•Recidivating porphyria
•Any significant morbidity interfering with study drug or procedures according to the assessment of the Principal Investigator, such as myoma or cell atypia.
•Taken any analgesics 24 hours prior to IUD insertion

Study & Design

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