Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion
This study is currently recruiting participants.
Verified December 2011 by Ain Shams University
Sponsor:
Ain Shams University
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 13, 2011 | ||||
| Last Updated Date | December 20, 2011 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
VAS score of Pain [ Time Frame: 5 minutes from lidocaine spraying ( after application of tenaculum) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01496105 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
||||
| Condition ICMJE | Drug Usage | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Egypt | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01496105 | ||||
| Other Study ID Numbers ICMJE | ali elyan 2011 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mohamed Saied Eldin Elsafty, Ain Shams University | ||||
| Study Sponsor ICMJE | Ain Shams University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Ain Shams University | ||||
| Verification Date | December 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||