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NCT00269568 · ClinicalTrials.gov registry record · Phase 4
Mifepristone at Same Time Multicenter Study
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,128
- Enrollment target
NCT00269568 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 1,128 participants.
The verdict
NCT00269568, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,128 participants
- Enrollment target
Study Summary
This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%
Interventions
- DRUG mifepristone and misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,128 participants |
| Start Date | 2004-06 |
| Est. Completion | 2006-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00269568
The ClinicalTrials.gov registry entry for NCT00269568 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,128 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 mifepristone and misoprostol is the first listed.
NCT00269568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00269568 about?
NCT00269568 is a clinical study titled "Mifepristone at Same Time Multicenter Study". This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal mis...
What is the current status of trial NCT00269568?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,128 participants. The study started on 2004-06. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00269568?
The interventions under investigation include: mifepristone and misoprostol (DRUG).
Who is sponsoring clinical trial NCT00269568?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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