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A randomized, double-blind, placebo controlled, parallel group clinical study investigating the analgesic effect and safety of a topical formulation of lidocaine (SHACT) during and after insertion of an Intra Uterine Device. A phase II study.

A randomized, double-blind, placebo controlled, parallel group clinical study investigating the analgesic effect and safety of a topical formulation of lidocaine (SHACT) during and after insertion of an Intra Uterine Device. A phase II study.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-006220-20-SE
Enrollment
200
Registered
2012-03-28
Start date
2012-05-08
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 relief during insertion of an intra uterine device MedDRA version: 15.0 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/

Sponsors

Pharmanest AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Nulliparous women with wish for IUD insertion • Minimum 18 years of age • a) If patient has regular periods, she must be in menstrual cycle day 1-6 at insertion, or pregnancy must be reliably excluded. b) If patient has no or small irregular bleedings due to hormonal contraception or due to other reasons, the insertion may take place at any convenient day, if pregnancy has been reliably excluded. • Able to understand Swedish language 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 200 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 inflammatory 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 • Known intolerance to paracetamol (rescue medication) • Recidivating porphyria • Any significant morbidity interfering with study drug or procedures according to the assessment of the Principal Investigator • Taken any analgesics 24 hours prior to IUD insertion • Previous pregnancy > 13 gestational weeks

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the maximum pain intensity experienced by the patient during and within 10 minutes after start of IUD insertion when treated with SHACT in comparison to placebo using a 100 mm VAS scale.;Secondary Objective: • To evaluate the pain intensity experienced by the patient after 1 and 2 hours after IUD insertion and after 24, 48 and 72 hours (day 2 – 4) in comparisons between SHACT 4% viscous solution and placebo using a VAS scale • To evaluate the safety and tolerability of SHACT used during IUD insertion. • To evaluate the need for rescue medication within the next 4 days after IUD insertion when treated with SHACT compared to placebo. ;Primary end point(s): Maximum pain intensity experienced by the patient during and within 10 minutes after start of IUD insertion when treated with SHACT in comparison to placebo—

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