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NCT00475228 · ClinicalTrials.gov registry record · Phase 4
'Levonorgestrel IUD Insertion After D&E Procedure
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 93
- Enrollment target
NCT00475228: Completed Phase 4 study, sponsored by University of Pittsburgh.
NCT00475228 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 93 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00475228, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 93 participants
- Enrollment target
Study Summary
This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation \& evacuation (D\&E) compared to delayed insertion 3-6 weeks post-D\&E. Eighty-eight women undergoing D\&E between 15 0/7 and 23 6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary outcome is LNG-IUD usage six months following enrollment. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D\&E procedure than women receiving delayed insertion. Secondary outcomes include the proportion receiving an IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The utility of ultrasonography in predicting expulsion will also be examined. Anticipated problems include poor subject follow-up and coordinating the intra-operative study procedures.
Primary Outcome
To assess the six-month usage rate of the LNG-IUD when placed immediately after D\&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D\&E. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D\&E procedure than women receiving delayed insertion.
Interventions
- DRUG Levonorgestrel IUD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-11 |
| Phase | Phase 4 |
What the finished NCT00475228 record still lists
NCT00475228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Levonorgestrel IUD is the first listed.
NCT00475228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00475228 about?
NCT00475228 is a clinical study titled "'Levonorgestrel IUD Insertion After D&E Procedure". This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation \& evacuation (D\&E) compared to delayed insertion 3-6 weeks post-D\&E. Eighty-eight women undergoing D\&E between 15 0/7 and 23 6/7 weeks gestation w...
What is the current status of trial NCT00475228?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 93 participants. The study started on 2007-03. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00475228?
The interventions under investigation include: Levonorgestrel IUD (DRUG).
Who is sponsoring clinical trial NCT00475228?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00475228's enrollment target sits among peer trials
93 874th of 2000 higher than 1,125 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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