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.
- Conditions
- Pain relief during insertion of an intra uterine deviceMedDRA version: 15.0Level: PTClassification code 10064882Term: Procedural painSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2011-006220-20-SE
- Lead Sponsor
- Pharmanest AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method