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NCT00308711 · ClinicalTrials.gov registry record · Phase 3
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
A Phase 3 study of Cervical Ripening and Labor, Induced, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,308
- Enrollment target
- 20
- Study locations
NCT00308711 is a Phase 3 study of Cervical Ripening and Labor, Induced that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 1,308 participants, above the 307-participant average among 8 other Cervical Ripening trials with a reported enrollment target (326% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT00308711, a Phase 3 study of Cervical Ripening and Labor, Induced, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,308 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
Conditions Studied
Interventions
- DRUG Misoprostol vaginal insert 100 mcg
- DRUG Misoprostol vaginal insert 50 mcg
- DRUG Dinoprostone vaginal insert (Cervidil)
Study Locations (20)
Arizona
- Banner Desert Medical Center - Mesa
- Maricopa Medical Center - Phoenix
- Arizona Wellness Center for Women - Phoenix
- Tuscon Medical Center - Tucson
California
- Long Beach Memorial Medical Center - Long Beach
- UCI Medical Center - Orange
- Santa Clara Valley Medical Center - San Jose
Florida
- Bayfront Medical Center - St. Petersburg
- University of Florida Health Sciences Center - Tampa
- St. Mary's Medical Center - West Palm Beach
New York
- United Health Services Hospitals, Inc. - Johnson City
- Winthrop-South Nassau University Health Center - Mineola
Alabama
- University of Alabama at Birmingham Medical Center - Birmingham
Delaware
- Christiana Care Health System - Newark
Georgia
- Northside Hospital - Alpharetta
Michigan
- Hurley Medical Center - Flint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,308 participants |
| Start Date | 2006-04 |
| Est. Completion | 2007-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00308711
The ClinicalTrials.gov registry entry for NCT00308711 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,308 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 307-participant average among 8 other Cervical Ripening trials with a reported enrollment target (326% higher). The listed sponsor is Ferring Pharmaceuticals, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cervical Ripening appearing as the primary indexed condition, and to 3 interventions - of which Misoprostol vaginal insert 100 mcg is the first listed.
NCT00308711 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00308711 about?
NCT00308711 is a clinical study titled "Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor". The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
What is the current status of trial NCT00308711?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,308 participants. The study started on 2006-04. Estimated completion is 2007-08.
What conditions does trial NCT00308711 study?
This clinical trial studies the following conditions: Cervical Ripening, Labor, Induced.
What interventions are being tested in trial NCT00308711?
The interventions under investigation include: Misoprostol vaginal insert 100 mcg (DRUG), Misoprostol vaginal insert 50 mcg (DRUG), Dinoprostone vaginal insert (Cervidil) (DRUG).
Who is sponsoring clinical trial NCT00308711?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00308711 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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