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NCT01101841 · ClinicalTrials.gov registry record · Phase 3
24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
A Phase 3 study of Hot Flashes, sponsored by Noven Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 570
- Enrollment target
- 20
- Study locations
NCT01101841 is a Phase 3 study of Hot Flashes that has completed, run by Noven Therapeutics. The registered enrollment target is 570 participants, above the 147-participant average among 23 other Hot Flashes trials with a reported enrollment target (288% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT01101841, a Phase 3 study of Hot Flashes, has completed, sponsored by Noven Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 570 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
Conditions Studied
Interventions
- DRUG Placebo capsules
- DRUG Brisdelle (paroxetine mesylate)
Study Locations (20)
Florida
- Visions Clinical Research - Boynton Beach
- Meridien Research - Brooksville
- Women's Medical Research Group, LLC - Clearwater
- Altus Research - Lake Worth
- Anchor Research Center - Naples
- Comprehensive Clinical Trials, LLC - West Palm Beach
California
- Genesis Center For Clinical Research - San Diego
- Apex Research Institute - Santa Ana
Georgia
- Soapstone Center for Clinical Research - Decatur
- Mount Vernon Clinical Research, LLC - Sandy Springs
North Carolina
- Hawthorne Research - Greensboro
- Hawthorne Medical Research, Inc. - Winston-Salem
Alabama
- Montgomery Women's Health Associates, PC - Montgomery
Arizona
- East Valley Family Physicians PLC - Chandler
Colorado
- Downtown Women's Health Care - Denver
Connecticut
- Chase Medical Research, LLC - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 570 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101841
The ClinicalTrials.gov registry entry for NCT01101841 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 570 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 147-participant average among 23 other Hot Flashes trials with a reported enrollment target (288% higher). 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 Placebo capsules is the first listed.
NCT01101841 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01101841 about?
NCT01101841 is a clinical study titled "24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms". To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
What is the current status of trial NCT01101841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 570 participants. The study started on 2010-03. Estimated completion is 2011-11.
What conditions does trial NCT01101841 study?
This clinical trial studies the following conditions: Hot Flashes.
What interventions are being tested in trial NCT01101841?
The interventions under investigation include: Placebo capsules (DRUG), Brisdelle (paroxetine mesylate) (DRUG).
Who is sponsoring clinical trial NCT01101841?
This trial is sponsored by Noven Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01101841 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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.