A Phase 4 interventional study of lidocaine spray and vaginal dinoprostone in Contraception, sponsored by Cairo University. Status unknown. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-09.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
four puffs (50ml, 10 mg/puff) of lidocaine spray will be applied to the cervical canal and cervix before tenaculum placement plus vaginal placebo will be given 3 hours before IUD insertion
Drug: lidocaine spray
vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement
Drug: vaginal dinoprostone
vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray will be applied to the cervical canal and cervix before tenaculum placement
Drug: placebo
four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
pain during IUD insertion
pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable
Time frame: 2 minutes
insertion duration
duration of LNG-IUD insertion from speculum in to speculum out
Time frame: 5 minutes
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Cairo University