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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005660-18-SE

Enrollment

Registered

2012-02-27

Start date

2012-03-26

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

Pain during insertion of an intra uterine device MedDRA version: 14.1 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: lidocaine CAS Number: 137-58-6 Current Sponsor code: SHACT Concentration unit: % (W/W) percent weight

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish the pharmacokinetic properties of SHACT including, AUC (0-120), Cmax and tmax, when applied in cervix and uterus of women receiving an IUD.;Secondary Objective: •To evaluate the safety and tolerability of SHACT used during IUD insertion. •To evaluate the pain and need of rescue medication. ;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Sweden

Contacts

Public ContactMedical Advisor

Pharmanest AB

gunvor.ekman-ordeberg@ki.se+46706083111

Outcome results

None listed

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