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NCT02738203 · ClinicalTrials.gov registry record · Phase 3
Self-Administered Lidocaine Gel for Pain Management With IUD Insertion
A Phase 3 study of IUD Insertion, sponsored by Stanford University.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 1
- Study location
NCT02738203: Completed Phase 3 study of IUD Insertion, sponsored by Stanford University.
NCT02738203 is a Phase 3 study of IUD Insertion that has completed, run by Stanford University. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02738203, a Phase 3 study of IUD Insertion, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 1
- Study location
Study Summary
For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.
Primary Outcome
Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale "0" had "no pain" and "100" had "worst pain imaginable" as anchors. A higher score indicates higher pain.
Conditions Studied
Interventions
- DRUG Vaginal 2% Lidocaine
- DRUG Surgical Lubricant Jelly
Study Locations (1)
California
- Stanford Gynecology Clinic - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2016-06-01 |
| Est. Completion | 2017-10-19 |
| Phase | Phase 3 |
What the finished NCT02738203 record still lists
NCT02738203 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 1 condition, with IUD Insertion appearing as the primary indexed condition, and to 2 interventions - of which Vaginal 2% Lidocaine is the first listed.
NCT02738203 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02738203 about?
NCT02738203 is a clinical study titled "Self-Administered Lidocaine Gel for Pain Management With IUD Insertion". For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit...
What is the current status of trial NCT02738203?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2016-06-01. Estimated completion is 2017-10-19.
What conditions does trial NCT02738203 study?
This clinical trial studies the following conditions: IUD Insertion.
What interventions are being tested in trial NCT02738203?
The interventions under investigation include: Vaginal 2% Lidocaine (DRUG), Surgical Lubricant Jelly (DRUG).
Who is sponsoring clinical trial NCT02738203?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02738203 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for IUD Insertion
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02738203's enrollment target sits among peer trials
220 1318th of 2000 higher than 672 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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