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NCT01445756 · ClinicalTrials.gov registry record · Early Phase 1
Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion
A Early Phase 1 study of Pain, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01445756: Completed Early Phase 1 study of Pain, sponsored by University of Wisconsin, Madison.
NCT01445756 is a Early Phase 1 study of Pain that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 40 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445756, a Early Phase 1 study of Pain, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal delivery. The potential pain associated with insertion is often a significant barrier for patients when choosing and IUD for contraception. Several methods of pain control have been studied, but none have been shown to reduce pain at time of insertion. Our research question is to determine if 2% topical lidocaine gel, instilled into the cervical canal, will reduce maximum pain at time of insertion of a popular IUD (Mirena Intrauterine System) in young, nulliparous patients. This will be studied in a randomized, double-blind placebo-controlled trial.
Primary Outcome
The investigators plan to engage 40 patients in this study, and will ask each to fill out a questionnaire that covers age, ethnicity, pregnancy history, reason for IUD insertion and recent medication use. Patients will be asked to assess their pain on 3 separate occasions during the visit, by marking an X on a Visual Analog Scale. Providers will also be asked to fill out a questionnaire covering their experience with the interventions as well as their assessment of the patients' pain during the
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lidocaine
Study Locations (1)
Wisconsin
- University Health Services Women's Care Clinic - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-06 |
| Phase | Early Phase 1 |
What the finished NCT01445756 record still lists
NCT01445756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01445756 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01445756 about?
NCT01445756 is a clinical study titled "Topical Lidocaine for Pain Control With Intrauterine Device (IUD) Insertion". Intrauterine contraception is a very effective, long term, reversible form of birth control, and is increasingly used in young, nulliparous patients. However, there is potential for pain with insertion of an Intrauterine Device (IUD) - particularly in patients without a previous history of vaginal d...
What is the current status of trial NCT01445756?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2010-07. Estimated completion is 2011-06.
What conditions does trial NCT01445756 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT01445756?
The interventions under investigation include: Placebo (DRUG), Lidocaine (DRUG).
Who is sponsoring clinical trial NCT01445756?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01445756 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01445756's enrollment target sits among peer trials
40 282nd of 374 higher than 85 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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