CompletedPhase 3

Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)

United States614 participantsStarted 2011-05

Plain-language summary

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.

Who can participate

Age range40 Years

SexFEMALE

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Inclusion criteria

✓. Female, ≥ 40 years of age at screening (inclusive)
✓. 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 to the screening visit
✓. Spontaneous amenorrhea for at least 12 consecutive months or
✓. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or
✓. Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy

Exclusion criteria

✕. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
✕. History of self injurious behavior
✕. History of clinical diagnosis of depression or treatment for depression
✕. History of clinical diagnosis of borderline personality disorder
✕. 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

What they're measuring

Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.

Timeframe: Week 4 and Week 12

Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12

Timeframe: Week 4 and Week 12

Trial details

NCT IDNCT01361308

SponsorNoven Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12

Results submitted2013-07-16

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