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NCT00330993 · ClinicalTrials.gov registry record · Phase 2
Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation
A Phase 2 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00330993 is a Phase 2 study that has completed, run by University of Pittsburgh. The registered enrollment target is 120 participants.
The verdict
NCT00330993, a Phase 2 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
HYPOTHESIS: For women with pregnancies at \<49, 50-56, and 57-63 days gestation who receive mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within each gestational age group. This is a prospective clinical trial. Women will be enrolled such that 40 women are in each of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment is initiated. Once a gestational age range includes 40 subjects, enrollment in that group will be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg misoprostol tablets between the check and gum (2 tablets on each side). The women will be instructed to keep the tablets in place for 30 minutes; any remaining portions of the tablets will be swallowed after this time. Participants will follow-up 24 hours after receiving the misoprostol. Vaginal ultrasonography will be performed to assess for expulsion of the gestational sac. Women who have not aborted by the first follow-up visit will be given a dose of vaginal misoprostol and will return for a follow-up visit in one week. Subjects who have not aborted by the two-week follow-up will be offered a surgical abortion. At each visit, data will be collected on bleeding, cramping, other side effects, and medication use.
Interventions
- DRUG mifepristone, misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00330993
The ClinicalTrials.gov registry entry for NCT00330993 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 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, misoprostol is the first listed.
NCT00330993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00330993 about?
NCT00330993 is a clinical study titled "Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation". HYPOTHESIS: For women with pregnancies at \<49, 50-56, and 57-63 days gestation who receive mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within each gestational age gro...
What is the current status of trial NCT00330993?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2006-03. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00330993?
The interventions under investigation include: mifepristone, misoprostol (DRUG).
Who is sponsoring clinical trial NCT00330993?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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