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

NCT01101841 | Completed Phase 3 Results

• 1 other identifier: N30-004
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 32

Brief Summary

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

Conditions

Hot Flashes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Hot Flash Frequency 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

  Week 4 and Week 12

Secondary Outcomes (15)

• Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.

  Week 24

• 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 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 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

Sugar pill

Drug: Placebo capsules

Interventions

Brisdelle (paroxetine mesylate) DRUG

Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

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

Brisdelle (paroxetine mesylate)

Placebo capsules DRUG

Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

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
• 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
• Spontaneous amenorrhea for at least 12 consecutive months
• Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
• Bilateral salpingo-oophorectomy \>6 weeks with or without hysterectomy

You may not qualify if:

• BMI ≥ 40 kg/m²
• 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 (32)

Montgomery Women's Health Associates, PC

Montgomery, Alabama, 36116, United States

Location

East Valley Family Physicians PLC

Chandler, Arizona, 85224, United States

Location

Genesis Center For Clinical Research

San Diego, California, 92103, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80218, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Women's Medical Research Group, LLC

Clearwater, Florida, 33759, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Anchor Research Center

Naples, Florida, 34102, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, 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

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, 68510, United States

Location

Phoenix Ob-Gyn Associates, LLC

Moorestown, New Jersey, 08057, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Hawthorne Research

Greensboro, North Carolina, 27408, United States

Location

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Columbus Center for Women's Health Research

Columbus, Ohio, 43213, 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

SC Clinical Research Center, LLC

Columbia, South Carolina, 29201, 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

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

The Woman's Hospital of Texas Clinical Research Center

Houston, Texas, 77054, United States

Location

Virginia Women's Center

Richmond, Virginia, 23233, United States

Location

National Clinical Research, Inc.

Richmond, Virginia, 23294, 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 (7)

• Fugate SE, Church CO. Nonestrogen treatment modalities for vasomotor symptoms associated with menopause. Ann Pharmacother. 2004 Sep;38(9):1482-99. doi: 10.1345/aph.1D610. Epub 2004 Aug 3.

  PMID: 15292498 BACKGROUND

• Kritz-Silverstein D, Goldani Von Muhlen D, Barrett-Connor E. Prevalence and clustering of menopausal symptoms in older women by hysterectomy and oophorectomy status. J Womens Health Gend Based Med. 2000 Sep;9(7):747-55. doi: 10.1089/15246090050147727.

  PMID: 11025867 BACKGROUND

• Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. doi: 10.1001/jama.295.17.2057.

  PMID: 16670414 BACKGROUND

• Greene JG. A factor analytic study of climacteric symptoms. J Psychosom Res. 1976;20(5):425-30. doi: 10.1016/0022-3999(76)90005-2. No abstract available.

  PMID: 1003364 BACKGROUND

• 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

Conditions

Hot Flashes

Interventions

Paroxetine; Sugars

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Derrick R Havin, MD

  North Spokane Women's Clinic Research, Spokane, WA 99207

  PRINCIPAL INVESTIGATOR

• Richard E Hedrick, MD

  Hawthorne Medical Research, Inc., Winston-Salem, NC 27103

  PRINCIPAL INVESTIGATOR

• Samuel N Lederman, MD

  Altus Research, Lake Worth, FL 33461

  PRINCIPAL INVESTIGATOR

• Larry S Seidman, DO

  Philadelphia Clinical Research, LLC, Philadelphia, PA 19114

  PRINCIPAL INVESTIGATOR

• James E Tomblin, MD

  Hawthorne Medical Research, Inc., Greensboro, NC 27408

  PRINCIPAL INVESTIGATOR

• Peter A Zedler, MD

  Virginia Women's Center, Richmond, VA 23233

  PRINCIPAL INVESTIGATOR

• D S Harnsberger, MD

  Chattanooga Medical Research, LLC, Chattanooga, TN 37404

  PRINCIPAL INVESTIGATOR

• John A Hoekstra, MD

  National Clinical Research, Inc., Richmond, VA 23294

  PRINCIPAL INVESTIGATOR

• Robin Kroll, MD

  Women's Clinical Research Center, Seattle, WA 98105

  PRINCIPAL INVESTIGATOR

• Ashley Tunkle, MD

  Anchor Research Center, Naples, FL 34102

  PRINCIPAL INVESTIGATOR

• Matthew Davis, MD

  Rochester Clinical Research, Rochester, NY 14609

  PRINCIPAL INVESTIGATOR

• Donna DeSantis, MD

  East Valley Family Physicians PLC, Chandler, AZ 85224

  PRINCIPAL INVESTIGATOR

• Steven Drosman

  Genesis Center For Clinical Research, San Diego, CA 92103

  PRINCIPAL INVESTIGATOR

• Mildred Farmer, MD

  Meridien Research, Brooksville, FL 34601

  PRINCIPAL INVESTIGATOR

• Sandra Hurtado, MD

  The Woman's Hospital of Texas Clinical Research Center, Houston, TX 77054

  PRINCIPAL INVESTIGATOR

• Bruce Levine, MD

  Phoenix Ob-Gyn Associates, LLC, Moorestown, NJ 08057

  PRINCIPAL INVESTIGATOR

• Tyrone Malloy, MD

  Soapstone Center for Clinical Research, Decatur, GA 30034

  PRINCIPAL INVESTIGATOR

• Eric Ross, MD

  Apex Research Institute, Santa Ana, CA 92705

  PRINCIPAL INVESTIGATOR

• Cynthia Strout, MD

  Coastal Carolina Research Center, Mt. Pleasant, SC 29464

  PRINCIPAL INVESTIGATOR

• Arthur Waldbaum, MD

  Downtown Women's Health Care, Denver, CO, 80218

  PRINCIPAL INVESTIGATOR

• Edward Zbella, MD

  Women's Medical Research Group, LLC, Clearwater, FL 33759

  PRINCIPAL INVESTIGATOR

• James R Dockery, MD

  Montgomery Women's Health Associates, PC, Montgomery, AL 36116

  PRINCIPAL INVESTIGATOR

• Stephen C Blank, MD

  Mount Vernon Clinical Research, LLC, Sandy Springs, GA 30328

  PRINCIPAL INVESTIGATOR

• Keith Aqua, MD

  Visions Clinical Research, Boynton Beach, FL 33472

  PRINCIPAL INVESTIGATOR

• Saul R Berg, MD

  Clinical Trials Research Services, LLC, Pittsburgh, PA 15206

  PRINCIPAL INVESTIGATOR

• Marvin Kalafer, MD

  The Clinical Trial Center, LLC, Jenkintown, PA 19046

  PRINCIPAL INVESTIGATOR

• David J Portman, MD

  Columbus Center for Women's Health Research, Columbus, Ohio 43213

  PRINCIPAL INVESTIGATOR

• Stephen Swanson, MD

  Women's Clinic of Lincoln, PC, Lincoln, NE 68510

  PRINCIPAL INVESTIGATOR

• Joseph Soufer, MD

  Chase Medical Research, LLC, Waterbury, CT 06708

  PRINCIPAL INVESTIGATOR

• ShaH R Scott, MD

  Clinical Research Associates, Inc., Nashville, TN 37203

  PRINCIPAL INVESTIGATOR

• Mary K Neuffer, MD

  SC Clinical Research Center, LLC, Columbia, SC 29201

  PRINCIPAL INVESTIGATOR

• Ronald Ackerman, MD

  Comprehensive Clinical Trials, LLC, West Palm Beach, FL 33409

  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: April 8, 2010
• First Posted: April 12, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 15, 2015
• Results First Posted: April 21, 2014

Record last verified: 2015-10

Locations

US (32)