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

NCT00786188 | Completed Phase 2 Results

• 1 other identifier: N30-002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 10

Brief Summary

This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (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

Conditions

Hot Flashes

Keywords

Menopause; Vasomotor Symptoms; Hot flash; 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 8

  The number of hot flashes reported in the result table are: * 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 8. They are both measured as hot flashes per week.

  Week 4 and Week 8

• Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8

  A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity. SS = (2•Fm + 3•Fs) ÷ (Fm + Fs) Where: SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score.

  Week 4 and Week 8

Secondary Outcomes (9)

• Change From Baseline in Climacteric Symptoms at Week 8

  Week 8

• Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8

  Week 4 and Week 8

• Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8

  Week 8

• Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4

  Week 4

• Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4

  Week 4

Study Arms (2)

Brisdelle (paroxetine mesylate)

EXPERIMENTAL

Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.

Drug: Brisdelle (paroxetine mesylate)

Placebo - Sugar Pill

PLACEBO COMPARATOR

Eligible subjects will be randomized to receive a sugar pill.

Drug: Sugar pill

Interventions

Brisdelle (paroxetine mesylate) DRUG

Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg.

Also known as: Former Names: Mesafem capsules 7.5 mg or, LDMP (Low-Dose Mesylate salt of Paroxetine)

Brisdelle (paroxetine mesylate)

Sugar pill DRUG

Subjects will receive a sugar pill.

Placebo - Sugar Pill

Eligibility Criteria

• Age: 41 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:

• History of hypersensitivity or adverse reaction to paroxetine mesylate
• 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 (10)

Altus Research

Lake Worth, Florida, 33461, United States

Location

Anchor Research Center

Naples, Florida, 34102, United States

Location

Hawthorne Research

Greensboro, North Carolina, 27408, United States

Location

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Philadelphia Clinical Research

Philadelphia, Pennsylvania, 19114, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, 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 (4)

• 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

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

• Patrick F. Freuen, MD

  North Spokane Women's Clinic, 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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 6, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 15, 2015
• Results First Posted: March 12, 2014

Record last verified: 2015-10

Locations

US (10)