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Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Ain Shams University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mohamed Saied Eldin Elsafty, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01496105
First received: December 13, 2011
Last updated: December 20, 2011
Last verified: December 2011

December 13, 2011
December 20, 2011
July 2011
December 2011   (final data collection date for primary outcome measure)
VAS score of Pain [ Time Frame: 5 minutes from lidocaine spraying ( after application of tenaculum) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01496105 on ClinicalTrials.gov Archive Site
Not Provided
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Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion
Not Provided

The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Drug Usage
  • Drug: Lidocaine
  • Drug: saline
  • Active Comparator: lidocaine spray 10%
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Saline
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-45
  • Speak Arabic or English

Exclusion Criteria:

  • History of cervical surgery
  • Known hypersensitivity to topical analgesics
  • First trimester abortion or miscarriage in the previous six weeks
  • Second trimester abortion or miscarriage in the previous 12 weeks
Female
18 Years to 45 Years
Yes
Contact: Mohamed S.Eldin Elsafty, Lecturer +201003922211 emeira2@gmail.com
Egypt
 
NCT01496105
ali elyan 2011
Yes
Mohamed Saied Eldin Elsafty, Ain Shams University
Ain Shams University
Not Provided
Not Provided
Ain Shams University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP