Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Summary
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
Timeline
- Start
- 2008-11
- Primary completion
- 2009-06
- Completion
- 2009-06
Outcome
Mixed primary results
registry analysis (superiority or other test); Brisdelle (Paroxetine Mesylate) Capsules vs Placebo - Sugar Pill; p = 0.0177; Repeated measures analysis; note: Week 4 frequency NCT00786188 ↗
registry analysis (superiority or other test); Brisdelle (Paroxetine Mesylate) Capsules vs Placebo - Sugar Pill; p = 0.0541; Reapeated measures analysis; note: Week 8 frequency NCT00786188 ↗
registry analysis (superiority or other test); Brisdelle (Paroxetine Mesylate) Capsules vs Placebo - Sugar Pill; p = 0.0644; Reapeated measures analysis; note: Week 4 severity NCT00786188 ↗
registry analysis (superiority or other test); Brisdelle (Paroxetine Mesylate) Capsules vs Placebo - Sugar Pill; p = 0.0364; Reapeated measures analysis; note: Week 8 severity NCT00786188 ↗
Publications
- Background Fugate SE, Church CO. Nonestrogen treatment modalities for vasomotor symptoms associated with menopause. Ann Pharmacother. 2004 Sep;38(9):1482-99. doi: 10.1345/aph.1D610. Epub 2004 Aug 3.
- Background Kritz-Silverstein D, Goldani Von Muhlen D, Barrett-Connor E. Prevalence and clustering of menopausal symptoms in older women by hysterectomy and oophorectomy status. J Womens Health Gend Based Med. 2000 Sep;9(7):747-55. doi: 10.1089/15246090050147727.
- Background Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. doi: 10.1001/jama.295.17.2057.
- Background Greene JG. A factor analytic study of climacteric symptoms. J Psychosom Res. 1976;20(5):425-30. doi: 10.1016/0022-3999(76)90005-2. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paroxetine | Small molecule | 7.5 mg | — |
Indications
No indication recorded.