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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: Completed Phase 2 study of Cervical Priming, sponsored by Ferring Pharmaceuticals.
NCT00925938 is a Phase 2 study of Cervical Priming that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00925938 record still lists
NCT00925938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT00925938's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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