Status:
COMPLETED
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Lead Sponsor:
Noven Therapeutics
Conditions:
Hot Flashes
Eligibility:
FEMALE
41+ years
Phase:
PHASE2
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 vaso...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00786188
Start Date
November 1 2008
End Date
June 1 2009
Last Update
October 15 2015
Active Locations (10)
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1
Altus Research
Lake Worth, Florida, United States, 33461
2
Anchor Research Center
Naples, Florida, United States, 34102
3
Hawthorne Research
Greensboro, North Carolina, United States, 27408
4
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States, 27103