Clinical trial NCT01361308: Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Symptoms
Keywords: Menopause
Vasomotor Symptoms
Hot Flashes Perimenopause
Climacteric Symptoms
Mesafem
Low-Dose Mesylate salt of Paroxetine (LDMP)
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 614
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules in subjects with moderate to severe postmenopausal VMS, defined as follows:

* Moderate VMS: Sensation of heat with sweating, able to continue activity
* Severe VMS: Sensation of heat with sweating, causing cessation of activity

The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Eligibility criteria: Inclusion Criteria:

1. Female, ≥ 40 years of age at screening (inclusive)
2. 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
3. Spontaneous amenorrhea for at least 12 consecutive months or
4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or
5. Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy

Exclusion Criteria:

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

Primary outcomes:
measure: Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.
timeFrame: Week 4 and Week 12
measure: Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12
timeFrame: Week 4 and Week 12
Secondary outcomes:
measure: Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%)
timeFrame: Week 4 and Week 12
measure: Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median
timeFrame: Week 4 and Week 12
measure: Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median
timeFrame: Week 4 and Week 12
measure: Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median
timeFrame: Week 4 and Week 12
measure: Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median
timeFrame: Week 4 and Week 12
measure: Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median
timeFrame: Week 4 and Week 12
measure: Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median
timeFrame: Week 4 and Week 12
measure: Percentage of Responders
timeFrame: Week 4 and Week 12
measure: Percentage of Patient Global Improvement (PGI) Scale Responders (%)
timeFrame: Week 4 and Week 12
measure: Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)
timeFrame: Week 4 and Week 12
measure: Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score
timeFrame: Week 4 and Week 12
measure: Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: Week 4 and Week 12
measure: Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.
timeFrame: Week 4 and Week 12
measure: Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression
timeFrame: Week 4 and Week 12
measure: Assessment of Mood
timeFrame: Week 4 and Week 12
measure: BMI Change From Baseline (kg/m2), Median
timeFrame: Week 4 and Week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Wilmax Clinical Research
state: Alabama
city: Chandler
country: United States
facility: East Valley Family Physicians PLC
state: Arizona
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: Peoria
country: United States
facility: Premier Research Group Limited
state: Arizona
city: Tucson
country: United States
facility: Verona Clinical Research, Inc
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Women's Clinic
state: Arkansas
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: Lancaster
country: United States
facility: High Desert Medical Group
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: University Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Fort Collins
country: United States
facility: The Women's Clinic of Northern Colorado
state: Colorado
city: Danbury
country: United States
facility: Danbury Clinical Research, LLC
state: Connecticut
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Washington
country: United States
facility: James A. Simon, MD, PC
state: District of Columbia
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Deerfield Beach
country: United States
facility: DBC Research
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine - Jacksonville Southside Women's Health
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Arlington Heights
country: United States
facility: Affinity Healthcare
state: Illinois
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Newton
country: United States
facility: Neurocare Center for Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: ClinSite, LLC
state: Michigan
city: Benzonia
country: United States
facility: Professional Clinical Research
state: Michigan
city: Detroit
country: United States
facility: Hutzel Womens Health Research
state: Michigan
city: Interlochen
country: United States
facility: Professional Clinical Research
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence Ob-Gyn Assoc., PC
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Inc.
state: New Mexico
city: New York
country: United States
facility: NY Center for Women's Health Research
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Columbus Center for Women's Health Research
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Mayfield Heights
country: United States
facility: University Hospitals of Cleveland Landerbrook Health Center
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research, Inc.
state: Oklahoma
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Wexford
country: United States
facility: Susan L Floyd, MD, PC
state: Pennsylvania
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc.
state: Tennessee
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas Clinical Research Center
state: Texas
city: Katy
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Richmond
country: United States
facility: Virginia Women's Center
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research, Inc
state: Virginia
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: North Spokane Women's Clinic Research
state: Washington
Study officials:
name: Corey Jacobs, MD
role: PRINCIPAL_INVESTIGATOR
name: Donna DeSantis, MD
role: PRINCIPAL_INVESTIGATOR
name: Robert Phillips, MD
role: PRINCIPAL_INVESTIGATOR
name: Louise Taber, MD
role: PRINCIPAL_INVESTIGATOR
name: Paige C. Brainard, MD
role: PRINCIPAL_INVESTIGATOR
name: Mark Stripling, MD
role: PRINCIPAL_INVESTIGATOR
name: Gioi Smith-Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
name: Anthony Dulgeroff, MD
role: PRINCIPAL_INVESTIGATOR
name: Elise Kwon, MD
role: PRINCIPAL_INVESTIGATOR
name: Douglas Young, MD
role: PRINCIPAL_INVESTIGATOR
name: William Koltun, MD
role: PRINCIPAL_INVESTIGATOR
name: Dana Shipp, MD
role: PRINCIPAL_INVESTIGATOR
name: Eric Ross, MD
role: PRINCIPAL_INVESTIGATOR
name: Arthur Waldbaum, MD
role: PRINCIPAL_INVESTIGATOR
name: Theodore Cooper, MD
role: PRINCIPAL_INVESTIGATOR
name: J B. Stern, MD
role: PRINCIPAL_INVESTIGATOR
name: Paul DiGrazia, MD
role: PRINCIPAL_INVESTIGATOR
name: Robert Spitz, MD
role: PRINCIPAL_INVESTIGATOR
name: James A Simon, MD
role: PRINCIPAL_INVESTIGATOR
name: Mildred Farmer, MD
role: PRINCIPAL_INVESTIGATOR
name: James Andersen, MD
role: PRINCIPAL_INVESTIGATOR
name: Steven Bowman, MD
role: PRINCIPAL_INVESTIGATOR
name: Rene Casanova, MD
role: PRINCIPAL_INVESTIGATOR
name: Mary Yankaskas, MD
role: PRINCIPAL_INVESTIGATOR
name: Andrew Kaunitz, MD
role: PRINCIPAL_INVESTIGATOR
name: Ronald Surowitz, MD
role: PRINCIPAL_INVESTIGATOR
name: Lisa Cohen, MD
role: PRINCIPAL_INVESTIGATOR
name: Lisa Vendeland, MD
role: PRINCIPAL_INVESTIGATOR
name: Tyrone Malloy, MD
role: PRINCIPAL_INVESTIGATOR
name: Stephen C. Blank, MD
role: PRINCIPAL_INVESTIGATOR
name: Mark Turner, MD
role: PRINCIPAL_INVESTIGATOR
name: Carl R Lang, MD
role: PRINCIPAL_INVESTIGATOR
name: Arthur Donovan, MD
role: PRINCIPAL_INVESTIGATOR
name: Armen Arslanian, MD
role: PRINCIPAL_INVESTIGATOR
name: Shiao-Yu Lee, MD
role: PRINCIPAL_INVESTIGATOR
name: Gayle Moyer, MD
role: PRINCIPAL_INVESTIGATOR
name: Geoffrey Turner, MD
role: PRINCIPAL_INVESTIGATOR
name: Susan L Hendrix, MD
role: PRINCIPAL_INVESTIGATOR
name: Mark Barber, MD
role: PRINCIPAL_INVESTIGATOR
name: Stephen Swanson, MD
role: PRINCIPAL_INVESTIGATOR
name: Timothy Sauter, MD
role: PRINCIPAL_INVESTIGATOR
name: Steven Sussman, MD
role: PRINCIPAL_INVESTIGATOR
name: Elizabeth Bretton, MD
role: PRINCIPAL_INVESTIGATOR
name: Lance A. Rudolph, MD
role: PRINCIPAL_INVESTIGATOR
name: Kenneth Levey, MD
role: PRINCIPAL_INVESTIGATOR
name: Pouru Bhiwandi, MD
role: PRINCIPAL_INVESTIGATOR
name: Richard E. Hedrick, MD
role: PRINCIPAL_INVESTIGATOR
name: Gregory P Tarleton, MD
role: PRINCIPAL_INVESTIGATOR
name: Mira Baron, MD
role: PRINCIPAL_INVESTIGATOR
name: David J Portman, MD
role: PRINCIPAL_INVESTIGATOR
name: Milroy Samuel, MD
role: PRINCIPAL_INVESTIGATOR
name: Stuart Weprin, MD
role: PRINCIPAL_INVESTIGATOR
name: James Liu, MD
role: PRINCIPAL_INVESTIGATOR
name: Angelique Barreto, MD
role: PRINCIPAL_INVESTIGATOR
name: Marvin Kalafer, MD
role: PRINCIPAL_INVESTIGATOR
name: Larry S. Seidman, MD
role: PRINCIPAL_INVESTIGATOR
name: Saul R. Berg, MD
role: PRINCIPAL_INVESTIGATOR
name: Susan Floyd, MD
role: PRINCIPAL_INVESTIGATOR
name: Scott Wilson, MD
role: PRINCIPAL_INVESTIGATOR
name: Cynthia Strout, MD
role: PRINCIPAL_INVESTIGATOR
name: D. S. Harnsberger, MD
role: PRINCIPAL_INVESTIGATOR
name: Janet Dittus, MD
role: PRINCIPAL_INVESTIGATOR
name: Gregg Lucksinger, MD
role: PRINCIPAL_INVESTIGATOR
name: Anna Damian, MD
role: PRINCIPAL_INVESTIGATOR
name: Sandra Hurtado, MD
role: PRINCIPAL_INVESTIGATOR
name: Alfred Poindexter, MD
role: PRINCIPAL_INVESTIGATOR
name: Nancy Campbell, MD
role: PRINCIPAL_INVESTIGATOR
name: William Jennings, MD
role: PRINCIPAL_INVESTIGATOR
name: Jose Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
name: John A. Hoekstra, MD
role: PRINCIPAL_INVESTIGATOR
name: Peter A. Zedler, MD
role: PRINCIPAL_INVESTIGATOR
name: Franklin Morgan, MD
role: PRINCIPAL_INVESTIGATOR
name: Robin Kroll, MD
role: PRINCIPAL_INVESTIGATOR
name: Derrick R Havin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.