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NCT01292447 · ClinicalTrials.gov registry record · NA
A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
A NA study, sponsored by Women and Infants Hospital of Rhode Island.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT01292447: Completed NA study, sponsored by Women and Infants Hospital of Rhode Island.
NCT01292447 is a NA study that has completed, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01292447, a NA study, has completed, sponsored by Women and Infants Hospital of Rhode Island.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.
Primary Outcome
0 to 100 mm visual analog scale, higher values represent more pain.
Interventions
- DRUG Placebo gel
- DRUG 2% lidocaine gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-02 |
| Phase | NA |
What the finished NCT01292447 record still lists
NCT01292447 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo gel is the first listed.
NCT01292447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01292447 about?
NCT01292447 is a clinical study titled "A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion". The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduc...
What is the current status of trial NCT01292447?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2011-02. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01292447?
The interventions under investigation include: Placebo gel (DRUG), 2% lidocaine gel (DRUG).
Who is sponsoring clinical trial NCT01292447?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01292447's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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