ClinicalTrials.gov record
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
ClinicalTrials.gov ID: NCT01361308
Public ClinicalTrials.gov record NCT01361308. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 17, 2026, 8:46 PM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Twelve-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause
Study identification
- NCT ID
- NCT01361308
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Noven Therapeutics
- Industry
- Enrollment
- 614 participants
Conditions and interventions
Conditions
Interventions
- Brisdelle (paroxetine mesylate) Drug
- Placebo capsules Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2011
- Primary completion
- Nov 30, 2011
- Completion
- Jan 31, 2012
- Last update posted
- Oct 14, 2015
2011 – 2012
United States locations
- U.S. sites
- 74
- U.S. states
- 29
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Wilmax Clinical Research | Mobile | Alabama | 36608 | — |
| East Valley Family Physicians PLC | Chandler | Arizona | 85224 | — |
| Advanced Research Associates | Glendale | Arizona | 85308 | — |
| Premier Research Group Limited | Peoria | Arizona | 85381 | — |
| Verona Clinical Research, Inc | Tucson | Arizona | 85710 | — |
| NEA Baptist Women's Clinic | Jonesboro | Arkansas | 72401 | — |
| Grossmont Center for Clinical Research | La Mesa | California | 91942 | — |
| High Desert Medical Group | Lancaster | California | 93534 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| University Clinical Research | San Diego | California | 92103 | — |
| Medical Center for Clinical Research | San Diego | California | 92108 | — |
| Apex Research Institute | Santa Ana | California | 92705 | — |
| Downtown Women's Health Care | Denver | Colorado | 80218 | — |
| Horizons Clinical Research Center, LLC | Denver | Colorado | 80220 | — |
| The Women's Clinic of Northern Colorado | Fort Collins | Colorado | 80524 | — |
| Danbury Clinical Research, LLC | Danbury | Connecticut | 06810 | — |
| Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | — |
| James A. Simon, MD, PC | Washington D.C. | District of Columbia | 20036 | — |
| Meridien Research | Bradenton | Florida | 34208 | — |
| Meridien Research | Brooksville | Florida | 34601 | — |
| Tampa Bay Medical Research, Inc. | Clearwater | Florida | 33761 | — |
| DBC Research | Deerfield Beach | Florida | 33441 | — |
| Clinical Physiology Associates | Fort Myers | Florida | 33916 | — |
| University of Florida College of Medicine - Jacksonville Southside Women's Health | Jacksonville | Florida | 32207 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | — |
| Suncoast Clinical Research, Inc. | Palm Harbor | Florida | 34684 | — |
| Soapstone Center for Clinical Research | Decatur | Georgia | 30034 | — |
| Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | — |
| Advanced Clinical Research | Boise | Idaho | 83642 | — |
| Affinity Healthcare | Arlington Heights | Illinois | 60004 | — |
| Bluegrass Clinical Research, Inc. | Louisville | Kentucky | 40291 | — |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | — |
| Neurocare Center for Research | Newton | Massachusetts | 02459 | — |
| ClinSite, LLC | Ann Arbor | Michigan | 48106 | — |
| Professional Clinical Research | Benzonia | Michigan | 49616 | — |
| Hutzel Womens Health Research | Detroit | Michigan | 48201 | — |
| Professional Clinical Research | Interlochen | Michigan | 49643 | — |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | — |
| Lawrence Ob-Gyn Assoc., PC | Lawrenceville | New Jersey | 08648 | — |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | — |
| New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | — |
| NY Center for Women's Health Research | New York | New York | 10038 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Clinical Trials of America, Inc. | Winston-Salem | North Carolina | 27103 | — |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | — |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | — |
| Columbus Center for Women's Health Research | Columbus | Ohio | 43213 | — |
| Complete Healthcare for Women | Columbus | Ohio | 43231 | — |
| HWC Women's Research Center | Englewood | Ohio | 45424 | — |
| University Hospitals of Cleveland Landerbrook Health Center | Mayfield Heights | Ohio | 44124 | — |
| Sooner Clinical Research, Inc. | Oklahoma City | Oklahoma | 73112 | — |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | — |
| Philadelphia Clinical Research | Philadelphia | Pennsylvania | 19114 | — |
| Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | 15206 | — |
| Susan L Floyd, MD, PC | Wexford | Pennsylvania | 15090 | — |
| Partners in Clinical Research | Cumberland | Rhode Island | 02864 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | — |
| Access Clinical Trials, Inc. | Nashville | Tennessee | 37043 | — |
| Tekton Research | Austin | Texas | 78745 | — |
| DiscoveResearch, Inc. | Bryan | Texas | 77802 | — |
| Advances In Health, Inc. | Houston | Texas | 77030 | — |
| The Woman's Hospital of Texas Clinical Research Center | Houston | Texas | 77054 | — |
| Research Across America | Katy | Texas | 77450 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| Radiant Research, Inc. | San Antonio | Texas | 78229 | — |
| Virginia Women's Center | Richmond | Virginia | 23233 | — |
| National Clinical Research, Inc. | Richmond | Virginia | 23294 | — |
| Tidewater Clinical Research, Inc | Virginia Beach | Virginia | 23456 | — |
| Women's Clinical Research Center | Seattle | Washington | 98105 | — |
| North Spokane Women's Clinic Research | Spokane | Washington | 99207 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01361308, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2015 · Synced May 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01361308 live on ClinicalTrials.gov.