Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00925938 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy
A Phase 2 study of Cervical Priming, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 2
- Study locations
NCT00925938 is a Phase 2 study of Cervical Priming that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 51 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT00925938, a Phase 2 study of Cervical Priming, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 2
- Study locations
Study Summary
A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office hysteroscopy procedure. Each subject will be randomized to receive one vaginal insert. The study drug will be administered vaginally by a member of the clinical research team (Part I) or insert herself (Part II) 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The internal os of the cervix will be measured at baseline, just prior to the hysteroscopy and at the follow up visit. The primary outcome measure is change in diameter of the internal cervical os from baseline (pre-treatment) to just prior to the hysteroscopy procedure (post-treatment). The hypothesis is that treatment with the MVPI will soften and dilate the cervix better than placebo.
Conditions Studied
Interventions
- DRUG placebo
- DRUG misoprostol
Study Locations (2)
Arizona
- Precision Trials - Phoenix
North Carolina
- Lyndhurst Gynecologic Associates - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00925938
The ClinicalTrials.gov registry entry for NCT00925938 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Pharmaceuticals, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cervical Priming appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00925938 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00925938 about?
NCT00925938 is a clinical study titled "Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy". A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office hysteroscopy procedure. Each ...
What is the current status of trial NCT00925938?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2010-01. Estimated completion is 2010-11.
What conditions does trial NCT00925938 study?
This clinical trial studies the following conditions: Cervical Priming.
What interventions are being tested in trial NCT00925938?
The interventions under investigation include: placebo (DRUG), misoprostol (DRUG).
Who is sponsoring clinical trial NCT00925938?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00925938 being conducted?
This trial has 2 study locations across Arizona, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.