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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: Completed Phase 2 study of Hot Flashes, sponsored by Noven Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The number of hot flashes reported in the result table are: * Mean change in frequency of moderate to severe VMS from baseline to Week 4 * Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week.
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 |
What the finished NCT00786188 record still lists
NCT00786188 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 167-participant average among 23 other Hot Flashes trials with a reported enrollment target (39% lower).
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 lists 10 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT00786188's enrollment target sits among peer trials
102 13th of 23 higher than 11 of 23 other Hot Flashes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hot Flashes 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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