Conditions: Hot Flashes
Keywords: Vasomotor Symptoms Menopause Hot Flashes Perimenopause Nonhormonal therapies Climacteric symptoms Mesafem Low-Dose Mesylate salt of Paroxetine (LDMP)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 570
Healthy volunteers: no

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

Detailed description:
The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows:

1. Moderate VMS: Sensation of heat with sweating, able to continue activity
2. Severe VMS: Sensation of heat with sweating, causing cessation of activity

The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Arms:
arm 1: Brisdelle (paroxetine mesylate) arm 2: Sugar pill

Interventions: intervention 1: Brisdelle (paroxetine mesylate) intervention 2: Placebo capsules
Intervention descriptions: intervention 1: Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio. intervention 2: Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

Protocol document: