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NCT00786188 · ClinicalTrials.gov registry record · Phase 2
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
A Phase 2 study of Hot Flashes, sponsored by Noven Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 10
- Study locations
NCT00786188 is a Phase 2 study of Hot Flashes that has completed, run by Noven Therapeutics. The registered enrollment target is 102 participants, below the 167-participant average among 23 other Hot Flashes trials with a reported enrollment target (39% lower). The trial reports 10 study locations across 6 states.
The verdict
NCT00786188, a Phase 2 study of Hot Flashes, has completed, sponsored by Noven Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows: * Moderate VMS: Sensation of heat with sweating, able to continue activity * Severe VMS: Sensation of heat with sweating, causing cessation of activity
Conditions Studied
Interventions
- DRUG Brisdelle (paroxetine mesylate)
- DRUG Sugar pill
Study Locations (10)
Florida
- Altus Research - Lake Worth
- Anchor Research Center - Naples
North Carolina
- Hawthorne Research - Greensboro
- Hawthorne Medical Research, Inc. - Winston-Salem
Virginia
- Virginia Women's Center - Richmond
- National Clinical Research, Inc. - Richmond
Washington
- Women's Clinical Research Center - Seattle
- North Spokane Women's Clinic Research - Spokane
Pennsylvania
- Philadelphia Clinical Research - Philadelphia
Tennessee
- Chattanooga Medical Research, LLC - Chattanooga
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00786188
The ClinicalTrials.gov registry entry for NCT00786188 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 167-participant average among 23 other Hot Flashes trials with a reported enrollment target (39% lower). The listed sponsor is Noven Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hot Flashes appearing as the primary indexed condition, and to 2 interventions - of which Brisdelle (paroxetine mesylate) is the first listed.
NCT00786188 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Florida, North Carolina, Virginia.
Frequently Asked Questions
What is clinical trial NCT00786188 about?
NCT00786188 is a clinical study titled "Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause". This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows: * Moderate VMS: Sensation of heat with sweating, able to ...
What is the current status of trial NCT00786188?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2008-11. Estimated completion is 2009-06.
What conditions does trial NCT00786188 study?
This clinical trial studies the following conditions: Hot Flashes.
What interventions are being tested in trial NCT00786188?
The interventions under investigation include: Brisdelle (paroxetine mesylate) (DRUG), Sugar pill (DRUG).
Who is sponsoring clinical trial NCT00786188?
This trial is sponsored by Noven Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00786188 being conducted?
This trial has 10 study locations across Florida, North Carolina, Pennsylvania, Tennessee, Virginia. 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
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.