A Phase 3 interventional study of lidocaine gel and placebo gel in Contraception, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Assiut University · Phase 3, Interventional, and Treatment
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
lidocaine in-situ gel inserted vaginally
Drug: lidocaine gel
placebo gel inserted vaginally
Drug: placebo gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
The difference in pain scores during intrauterine device insertion
using visual analog scale from 0 to 10
Time frame: 10 minutes
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Assiut University