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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 Oct 30, 2026, 3:00 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, 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
Mar 2010 (Type not available)
Primary completion
Sep 2011 (Actual)
Completion
Nov 2011 (Actual)
Last update posted
Oct 15, 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 15, 2015 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01101841 live on ClinicalTrials.gov.

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