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

Noven Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hot Flashes

Treatments: Drug: Sugar pill; Drug: Brisdelle (paroxetine mesylate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00786188

N30-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 41+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

Brisdelle (paroxetine mesylate)

Experimental group

Description:

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

Treatment:

Drug: Brisdelle (paroxetine mesylate)

Placebo - Sugar Pill

Placebo Comparator group

Description:

Eligible subjects will be randomized to receive a sugar pill.

Treatment:

Drug: Sugar pill