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

Pharmanest AB0 个研究点目标入组 15 人开始时间: 2012年2月27日最近更新: 2020年6月2日

试验速览

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•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

•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

发起方

Pharmanest AB