Clinical trial NCT00786188: Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Official title: A Phase 2, Exploratory, Eight-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: PHASE2
Conditions: Hot Flashes
Keywords: Menopause
Vasomotor Symptoms
Hot flash
Perimenopause
Nonhormonal therapies
Climacteric symptoms
Mesafem
Low-Dose Mesylate salt of Paroxetine (LDMP)
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-11-06
Enrollment: 102
Sex: FEMALE
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. History of hypersensitivity or adverse reaction to paroxetine mesylate
2. Use of an investigational study medication within 30 days prior to screening or during the study
3. Concurrent participation in another clinical trial or previous participation in this trial
4. Family of investigational-site staff

Primary outcomes:
measure: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8
timeFrame: Week 4 and Week 8
Secondary outcomes:
measure: Change From Baseline in Climacteric Symptoms at Week 8
timeFrame: Week 8
measure: Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8
timeFrame: Week 8
measure: Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4
timeFrame: Week 4
measure: Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4
timeFrame: Week 4
measure: Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8
timeFrame: Week 8
measure: Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8
timeFrame: Week 4 and Week 8
Other outcomes:
Locations:
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: Greensboro
country: United States
facility: Hawthorne Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Philadelphia
country: United States
facility: Philadelphia Clinical Research
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
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: 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:
affiliation: North Spokane Women's Clinic, Spokane, WA 99207
name: Patrick F. Freuen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hawthorne Medical Research, Inc., Winston-Salem, NC 27103
name: Richard E. Hedrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Altus Research, Lake Worth, FL 33461
name: Samuel N. Lederman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philadelphia Clinical Research, LLC, Philadelphia, PA 19114
name: Larry S. Seidman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Hawthorne Medical Research, Inc., Greensboro, NC 27408
name: James E. Tomblin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Women's Center, Richmond, VA 23233
name: Peter A. Zedler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chattanooga Medical Research, LLC, Chattanooga, TN 37404
name: D. S. Harnsberger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Clinical Research, Inc., Richmond, VA 23294
name: John A. Hoekstra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's Clinical Research Center, Seattle, WA 98105
name: Robin Kroll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anchor Research Center, Naples, FL 34102
name: Ashley Tunkle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.