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COMPLETED Phase 3

Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

NCT00308711 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,308 participants
Start Date 2006-04
Est. Completion 2007-08
Phase Phase 3

Sponsor

Ferring Pharmaceuticals

27 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00308711 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00308711?

This trial is sponsored by Ferring Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial