title: Extended-release oxybutynin therapy for vasomotor symptoms in women: a randomized clinical trial.
abstract: Assess effects of once-daily, extended-release oxybutynin chloride on frequency and severity of vasomotor symptoms in healthy, postmenopausal symptomatic women.
  
  
  
  A 12-week, multicenter, double-blind, placebo-controlled, phase 2 clinical trial randomized naturally postmenopausal women experiencing at least seven moderate-to-severe vasomotor symptoms daily to oxybutynin 15 mg once daily (n = 73) or placebo (n = 75). Co-primary outcomes were the change from baseline to week 12 in the frequency and severity of moderate-to-severe vasomotor symptoms.
  
  
  
  Significant reductions in both frequency and severity of moderate-to-severe vasomotor symptoms in women who received oxybutynin compared with placebo were observed at all weeks of treatment (P ≤ 0.007, all time points) through week 12. Mean changes in frequency in the oxybutynin and placebo groups were -9.48 and -4.69 episodes/d, respectively, at week 12. Mean changes in severity (scale 0-3) in the oxybutynin and placebo groups were -1.27 and -0.30, respectively, at week 12. At the end of treatment, 73% of women in the oxybutynin group and 26.1% in the placebo group rated symptom improvement "much better" (P ≤ 0.001). Women treated with oxybutynin showed significant improvement in sleep quality, sleep disturbance, and the global sleep index on the Pittsburgh Sleep Quality Index (P ≤ 0.023). Dry mouth was reported by 52.1% of participants given oxybutynin and 5.3% of participants given placebo, leading to discontinuation of oxybutynin in 6.8% of participants.
  
  
  
  Oxybutynin is an effective, nonhormonal therapy for moderate-to-severe vasomotor symptoms in postmenopausal women.
authors.affiliation: 1Department of Obstetrics and Gynecology, George Washington University School of Medicine, Washington, DC 2Department of Health & Sciences, Stratford University, Falls Church, VA 3Icahn School of Medicine at Mount Sinai, New York, NY.
authors.forename: James A
authors.initials: JA
authors.lastname: Simon
authors.forename: Tatiana
authors.initials: T
authors.lastname: Gaines
authors.forename: Katherine D
authors.initials: KD
authors.lastname: LaGuardia
mesh_terms: D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008333:Mandelic Acids / Q000008:administration & dosage*; D008875:Middle Aged; D010919:Placebos; D017698:Postmenopause; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D008333:Mandelic Acids; D010919:Placebos; C005419:oxybutynin