Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Completed
Noven Therapeutics
Phase 2
2008-11-01
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
24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Completed
Noven Therapeutics
Phase 3
2010-03-01
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for
treatment of vasomotor symptoms (VMS) associated with menopause
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
Completed
Noven Therapeutics
Phase 3
2011-05-01
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.
Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
Completed
Noven Therapeutics
Phase 1
2011-07-01
The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and
elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate)
Capsules 7.5 mg when given as a single dose and multiple doses.
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