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NCT02388191 · ClinicalTrials.gov registry record · NA
Naproxen for Pain Control With Intrauterine Device Insertion
A NA study, sponsored by Planned Parenthood League of Massachusetts.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
NCT02388191: Completed NA study, sponsored by Planned Parenthood League of Massachusetts.
NCT02388191 is a NA study that has completed, run by Planned Parenthood League of Massachusetts. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02388191, a NA study, has completed, sponsored by Planned Parenthood League of Massachusetts.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
Study Summary
The purpose of this study is: 1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome). 2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes). 3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion. Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.
Primary Outcome
Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and th
Interventions
- OTHER Placebo tablet
- DRUG Naproxen sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT02388191 record still lists
NCT02388191 is an interventional study that assigns participants to a tested intervention. The registered 119 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 (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo tablet is the first listed.
NCT02388191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02388191 about?
NCT02388191 is a clinical study titled "Naproxen for Pain Control With Intrauterine Device Insertion". The purpose of this study is: 1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome). 2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sound...
What is the current status of trial NCT02388191?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2015-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02388191?
The interventions under investigation include: Placebo tablet (OTHER), Naproxen sodium (DRUG).
Who is sponsoring clinical trial NCT02388191?
This trial is sponsored by Planned Parenthood League of Massachusetts, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02388191's enrollment target sits among peer trials
119 803rd of 2000 higher than 1,198 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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