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

Noven Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hot Flashes

Treatments: Drug: Placebo capsules; Drug: Brisdelle (paroxetine mesylate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01101841

N30-004

Details and patient eligibility

About

To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause

Full 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.

Enrollment: 570 patients

Sex: Female

Ages: 40+ 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. BMI ≥ 40 kg/m²
2. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
3. History of self-injurious behavior
4. History of clinical diagnosis of depression; or treatment for depression
5. History of clinical diagnosis of borderline personality disorder
6. Use of an investigational study medication within 30 days prior to screening or during the study
7. Concurrent participation in another clinical trial or previous participation in this trial
8. Family of investigational-site staff

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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570 participants in 2 patient groups, including a placebo group

Brisdelle (paroxetine mesylate)

Experimental group

Description:

Brisdelle (paroxetine mesylate)

Treatment:

Drug: Brisdelle (paroxetine mesylate)

Placebo capsules

Placebo Comparator group

Description:

Sugar pill

Treatment:

Drug: Placebo capsules