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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 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 93 participants.
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.
Interventions
- DRUG Levonorgestrel IUD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00475228
The ClinicalTrials.gov registry entry for NCT00475228 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Levonorgestrel IUD is the first listed.
NCT00475228 reports 0 study locations.
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.
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