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Completed Phase 3 Interventional Results available

24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms

ClinicalTrials.gov ID: NCT01101841

Public ClinicalTrials.gov record NCT01101841. 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 Sep 10, 2026, 5:53 AM 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, Twenty-Four 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause

Study identification

NCT ID
NCT01101841
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Noven Therapeutics
Industry
Enrollment
570 participants

Conditions and interventions

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
Feb 28, 2010
Primary completion
Aug 31, 2011
Completion
Oct 31, 2011
Last update posted
Oct 14, 2015

2010 – 2011

United States locations

U.S. sites
32
U.S. states
18
U.S. cities
31
Facility City State ZIP Site status
Montgomery Women's Health Associates, PC Montgomery Alabama 36116
East Valley Family Physicians PLC Chandler Arizona 85224
Genesis Center For Clinical Research San Diego California 92103
Apex Research Institute Santa Ana California 92705
Downtown Women's Health Care Denver Colorado 80218
Chase Medical Research, LLC Waterbury Connecticut 06708
Visions Clinical Research Boynton Beach Florida 33472
Meridien Research Brooksville Florida 34601
Women's Medical Research Group, LLC Clearwater Florida 33759
Altus Research Lake Worth Florida 33461
Anchor Research Center Naples Florida 34102
Comprehensive Clinical Trials, LLC West Palm Beach Florida 33409
Soapstone Center for Clinical Research Decatur Georgia 30034
Mount Vernon Clinical Research, LLC Sandy Springs Georgia 30328
Women's Clinic of Lincoln, PC Lincoln Nebraska 68510
Phoenix Ob-Gyn Associates, LLC Moorestown New Jersey 08057
Rochester Clinical Research Rochester New York 14609
Hawthorne Research Greensboro North Carolina 27408
Hawthorne Medical Research, Inc. Winston-Salem North Carolina 27103
Columbus Center for Women's Health Research Columbus Ohio 43213
The Clinical Trial Center, LLC Jenkintown Pennsylvania 19046
Philadelphia Clinical Research Philadelphia Pennsylvania 19114
Clinical Trials Research Services, LLC Pittsburgh Pennsylvania 15206
SC Clinical Research Center, LLC Columbia South Carolina 29201
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464
Chattanooga Medical Research, LLC Chattanooga Tennessee 37404
Clinical Research Associates, Inc. Nashville Tennessee 37203
The Woman's Hospital of Texas Clinical Research Center Houston Texas 77054
Virginia Women's Center Richmond Virginia 23233
National Clinical Research, Inc. Richmond Virginia 23294
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 NCT01101841, 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 Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01101841 live on ClinicalTrials.gov.

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