Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)

NCT01361308 | Completed Phase 3 Results DMC

• 1 other identifier: N30-003
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 74

Brief Summary

The purpose of this study is to assess the safety \& efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.

Conditions

Postmenopausal Symptoms

Keywords

Menopause; Vasomotor Symptoms; Hot Flashes Perimenopause; Climacteric Symptoms; Mesafem; Low-Dose Mesylate salt of Paroxetine (LDMP)

Outcome Measures

Primary Outcomes (2)

• Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.

  Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week. The results reported are: * Mean Baseline frequency of moderate to severe VMS * 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 12.

  Week 4 and Week 12

• Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12

  Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes. Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below.

  Week 4 and Week 12

Secondary Outcomes (16)

• Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%)

  Week 4 and Week 12

• Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median

  Week 4 and Week 12

• Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median

  Week 4 and Week 12

• Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median

  Week 4 and Week 12

• Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median

  Week 4 and Week 12

Study Arms (2)

Brisdelle (paroxetine mesylate)

EXPERIMENTAL

Brisdelle (paroxetine mesylate)

Drug: Brisdelle (paroxetine mesylate)

Placebo Capsules

PLACEBO COMPARATOR

Placebo Capsules

Drug: Placebo capsules

Interventions

Brisdelle (paroxetine mesylate) DRUG

Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84

Also known as: Former Names: Mesafem Capsules or, LDMP (Low-Dose Mesylate salt of Paroxetine)

Brisdelle (paroxetine mesylate)

Placebo capsules DRUG

Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84

Also known as: Sugar pill

Placebo Capsules

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, ≥ 40 years of age at screening (inclusive)
• Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior to the screening visit
• Spontaneous amenorrhea for at least 12 consecutive months or
• Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or
• Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy

You may not qualify if:

• Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
• History of self injurious behavior
• History of clinical diagnosis of depression or treatment for depression
• History of clinical diagnosis of borderline personality disorder
• Use of an investigational study medication within 30 days prior to screening or during the study
• Concurrent participation in another clinical trial or previous participation in this trial
• Family of investigational-site staff

Sponsors & Collaborators

• Noven Therapeutics: lead

Study Sites (74)

Wilmax Clinical Research

Mobile, Alabama, 36608, United States

Location

East Valley Family Physicians PLC

Chandler, Arizona, 85224, United States

Location

Advanced Research Associates

Glendale, Arizona, 85308, United States

Location

Premier Research Group Limited

Peoria, Arizona, 85381, United States

Location

Verona Clinical Research, Inc

Tucson, Arizona, 85710, United States

Location

NEA Baptist Women's Clinic

Jonesboro, Arkansas, 72401, United States

Location

Grossmont Center for Clinical Research

La Mesa, California, 91942, United States

Location

High Desert Medical Group

Lancaster, California, 93534, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

University Clinical Research

San Diego, California, 92103, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80218, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

The Women's Clinic of Northern Colorado

Fort Collins, Colorado, 80524, United States

Location

Danbury Clinical Research, LLC

Danbury, Connecticut, 06810, United States

Location

Coastal Connecticut Research, LLC

New London, Connecticut, 06320, United States

Location

James A. Simon, MD, PC

Washington D.C., District of Columbia, 20036, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

Location

DBC Research

Deerfield Beach, Florida, 33441, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33916, United States

Location

University of Florida College of Medicine - Jacksonville Southside Women's Health

Jacksonville, Florida, 32207, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Suncoast Clinical Research, Inc.

Palm Harbor, Florida, 34684, United States

Location

Soapstone Center for Clinical Research

Decatur, Georgia, 30034, United States

Location

Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Advanced Clinical Research

Boise, Idaho, 83642, United States

Location

Affinity Healthcare

Arlington Heights, Illinois, 60004, United States

Location

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, 40291, United States

Location

Beacon Clinical Research, LLC

Brockton, Massachusetts, 02301, United States

Location

Neurocare Center for Research

Newton, Massachusetts, 02459, United States

Location

ClinSite, LLC

Ann Arbor, Michigan, 48106, United States

Location

Professional Clinical Research

Benzonia, Michigan, 49616, United States

Location

Hutzel Womens Health Research

Detroit, Michigan, 48201, United States

Location

Professional Clinical Research

Interlochen, Michigan, 49643, United States

Location

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, 68510, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Lawrence Ob-Gyn Assoc., PC

Lawrenceville, New Jersey, 08648, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

New Mexico Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

NY Center for Women's Health Research

New York, New York, 10038, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Clinical Trials of America, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Columbus Center for Women's Health Research

Columbus, Ohio, 43213, United States

Location

Complete Healthcare for Women

Columbus, Ohio, 43231, United States

Location

HWC Women's Research Center

Englewood, Ohio, 45424, United States

Location

University Hospitals of Cleveland Landerbrook Health Center

Mayfield Heights, Ohio, 44124, United States

Location

Sooner Clinical Research, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Philadelphia Clinical Research

Philadelphia, Pennsylvania, 19114, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Susan L Floyd, MD, PC

Wexford, Pennsylvania, 15090, United States

Location

Partners in Clinical Research

Cumberland, Rhode Island, 02864, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Access Clinical Trials, Inc.

Nashville, Tennessee, 37043, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

DiscoveResearch, Inc.

Bryan, Texas, 77802, United States

Location

Advances In Health, Inc.

Houston, Texas, 77030, United States

Location

The Woman's Hospital of Texas Clinical Research Center

Houston, Texas, 77054, United States

Location

Research Across America

Katy, Texas, 77450, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Radiant Research, Inc.

San Antonio, Texas, 78229, United States

Location

Virginia Women's Center

Richmond, Virginia, 23233, United States

Location

National Clinical Research, Inc.

Richmond, Virginia, 23294, United States

Location

Tidewater Clinical Research, Inc

Virginia Beach, Virginia, 23456, United States

Location

Women's Clinical Research Center

Seattle, Washington, 98105, United States

Location

North Spokane Women's Clinic Research

Spokane, Washington, 99207, United States

Location

Related Publications (3)

• Pinkerton JV, Joffe H, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Low-dose paroxetine (7.5 mg) improves sleep in women with vasomotor symptoms associated with menopause. Menopause. 2015 Jan;22(1):50-8. doi: 10.1097/GME.0000000000000311.

  PMID: 25137243 DERIVED

• Portman DJ, Kaunitz AM, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause. Menopause. 2014 Oct;21(10):1082-90. doi: 10.1097/GME.0000000000000210.

  PMID: 24552977 DERIVED

• Simon JA, Portman DJ, Kaunitz AM, Mekonnen H, Kazempour K, Bhaskar S, Lippman J. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause. 2013 Oct;20(10):1027-35. doi: 10.1097/GME.0b013e3182a66aa7.

  PMID: 24045678 DERIVED

Related Links

• Sponsor

MeSH Terms

Interventions

Paroxetine; Sugars

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Sailaja Bhaskar, Executive Director, Clinical Research
• Organization: Noven Therapeutics, LLC

sbhaskar@noven.com

(212) 287-0798

Study Officials

• Corey Jacobs, MD

  PRINCIPAL INVESTIGATOR

• Donna DeSantis, MD

  PRINCIPAL INVESTIGATOR

• Robert Phillips, MD

  PRINCIPAL INVESTIGATOR

• Louise Taber, MD

  PRINCIPAL INVESTIGATOR

• Paige C. Brainard, MD

  PRINCIPAL INVESTIGATOR

• Mark Stripling, MD

  PRINCIPAL INVESTIGATOR

• Gioi Smith-Nguyen, MD

  PRINCIPAL INVESTIGATOR

• Anthony Dulgeroff, MD

  PRINCIPAL INVESTIGATOR

• Elise Kwon, MD

  PRINCIPAL INVESTIGATOR

• Douglas Young, MD

  PRINCIPAL INVESTIGATOR

• William Koltun, MD

  PRINCIPAL INVESTIGATOR

• Dana Shipp, MD

  PRINCIPAL INVESTIGATOR

• Eric Ross, MD

  PRINCIPAL INVESTIGATOR

• Arthur Waldbaum, MD

  PRINCIPAL INVESTIGATOR

• Theodore Cooper, MD

  PRINCIPAL INVESTIGATOR

• J B. Stern, MD

  PRINCIPAL INVESTIGATOR

• Paul DiGrazia, MD

  PRINCIPAL INVESTIGATOR

• Robert Spitz, MD

  PRINCIPAL INVESTIGATOR

• James A Simon, MD

  PRINCIPAL INVESTIGATOR

• Mildred Farmer, MD

  PRINCIPAL INVESTIGATOR

• James Andersen, MD

  PRINCIPAL INVESTIGATOR

• Steven Bowman, MD

  PRINCIPAL INVESTIGATOR

• Rene Casanova, MD

  PRINCIPAL INVESTIGATOR

• Mary Yankaskas, MD

  PRINCIPAL INVESTIGATOR

• Andrew Kaunitz, MD

  PRINCIPAL INVESTIGATOR

• Ronald Surowitz, MD

  PRINCIPAL INVESTIGATOR

• Lisa Cohen, MD

  PRINCIPAL INVESTIGATOR

• Lisa Vendeland, MD

  PRINCIPAL INVESTIGATOR

• Tyrone Malloy, MD

  PRINCIPAL INVESTIGATOR

• Stephen C. Blank, MD

  PRINCIPAL INVESTIGATOR

• Mark Turner, MD

  PRINCIPAL INVESTIGATOR

• Carl R Lang, MD

  PRINCIPAL INVESTIGATOR

• Arthur Donovan, MD

  PRINCIPAL INVESTIGATOR

• Armen Arslanian, MD

  PRINCIPAL INVESTIGATOR

• Shiao-Yu Lee, MD

  PRINCIPAL INVESTIGATOR

• Gayle Moyer, MD

  PRINCIPAL INVESTIGATOR

• Geoffrey Turner, MD

  PRINCIPAL INVESTIGATOR

• Susan L Hendrix, MD

  PRINCIPAL INVESTIGATOR

• Mark Barber, MD

  PRINCIPAL INVESTIGATOR

• Stephen Swanson, MD

  PRINCIPAL INVESTIGATOR

• Timothy Sauter, MD

  PRINCIPAL INVESTIGATOR

• Steven Sussman, MD

  PRINCIPAL INVESTIGATOR

• Elizabeth Bretton, MD

  PRINCIPAL INVESTIGATOR

• Lance A. Rudolph, MD

  PRINCIPAL INVESTIGATOR

• Kenneth Levey, MD

  PRINCIPAL INVESTIGATOR

• Pouru Bhiwandi, MD

  PRINCIPAL INVESTIGATOR

• Richard E. Hedrick, MD

  PRINCIPAL INVESTIGATOR

• Gregory P Tarleton, MD

  PRINCIPAL INVESTIGATOR

• Mira Baron, MD

  PRINCIPAL INVESTIGATOR

• David J Portman, MD

  PRINCIPAL INVESTIGATOR

• Milroy Samuel, MD

  PRINCIPAL INVESTIGATOR

• Stuart Weprin, MD

  PRINCIPAL INVESTIGATOR

• James Liu, MD

  PRINCIPAL INVESTIGATOR

• Angelique Barreto, MD

  PRINCIPAL INVESTIGATOR

• Marvin Kalafer, MD

  PRINCIPAL INVESTIGATOR

• Larry S. Seidman, MD

  PRINCIPAL INVESTIGATOR

• Saul R. Berg, MD

  PRINCIPAL INVESTIGATOR

• Susan Floyd, MD

  PRINCIPAL INVESTIGATOR

• Scott Wilson, MD

  PRINCIPAL INVESTIGATOR

• Cynthia Strout, MD

  PRINCIPAL INVESTIGATOR

• D. S. Harnsberger, MD

  PRINCIPAL INVESTIGATOR

• Janet Dittus, MD

  PRINCIPAL INVESTIGATOR

• Gregg Lucksinger, MD

  PRINCIPAL INVESTIGATOR

• Anna Damian, MD

  PRINCIPAL INVESTIGATOR

• Sandra Hurtado, MD

  PRINCIPAL INVESTIGATOR

• Alfred Poindexter, MD

  PRINCIPAL INVESTIGATOR

• Nancy Campbell, MD

  PRINCIPAL INVESTIGATOR

• William Jennings, MD

  PRINCIPAL INVESTIGATOR

• Jose Ruiz, MD

  PRINCIPAL INVESTIGATOR

• John A. Hoekstra, MD

  PRINCIPAL INVESTIGATOR

• Peter A. Zedler, MD

  PRINCIPAL INVESTIGATOR

• Franklin Morgan, MD

  PRINCIPAL INVESTIGATOR

• Robin Kroll, MD

  PRINCIPAL INVESTIGATOR

• Derrick R Havin, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 26, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: October 15, 2015
• Results First Posted: May 20, 2014

Record last verified: 2015-10

Locations

US (74)