title: Phase III comparison of depomedroxyprogesterone acetate to venlafaxine for managing hot flashes: North Central Cancer Treatment Group Trial N99C7.
abstract: OBJECTIVE
  Vasomotor hot flashes are a common problem in menopausal women. Given concerns regarding estrogen and/or combined hormonal therapy, other treatment options are desired. Prior trials have confirmed that progestational agents and newer antidepressants effectively reduce hot flashes. This current trial compared a single intramuscular dose of medroxyprogesterone acetate (MPA), depot preparation, versus daily oral venlafaxine as treatment for hot flashes.
  
  
  METHODS
  Women with bothersome hot flashes were entered onto this trial, were randomly assigned to treatment, and then had a baseline week where hot flash scores were recorded without treatment. They were then treated and observed for 6 weeks; daily diaries were used to measure hot flash frequencies and severities. There were 109 patients per each arm randomly assigned to receive MPA 400 mg intramuscularly for a single dose versus venlafaxine 37.5 mg per day for a week, then 75 mg per day.
  
  
  RESULTS
  During the sixth week after random assignment, hot flash scores were reduced by 55% in the venlafaxine arm versus 79% in the MPA arm (P < .0001). In an intention-to-treat analysis, 46% of venlafaxine patients (50 of 109) compared with 74% of the MPA patients (81 of 109) had a decrease in hot flashes by more than 50% from baseline (P < .0001). Less toxicity was reported in the MPA arm.
  
  
  CONCLUSIONS
  A single MPA dose seems to be well tolerated and more effectively reduces hot flashes than does venlafaxine.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. cloprinzi@mayo.edu
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: Ralph
authors.initials: R
authors.lastname: Levitt
authors.forename: Debra
authors.initials: D
authors.lastname: Barton
authors.forename: Jeff A
authors.initials: JA
authors.lastname: Sloan
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Nikcevich
authors.forename: James D
authors.initials: JD
authors.lastname: Bearden
authors.forename: James A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: Loren K
authors.initials: LK
authors.lastname: Tschetter
authors.forename: Tom R
authors.initials: TR
authors.lastname: Fitch
authors.forename: John W
authors.initials: JW
authors.lastname: Kugler
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003511:Cyclohexanols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008593:Menopause; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
chemical_list: D018931:Antineoplastic Agents, Hormonal; D003511:Cyclohexanols; D017258:Medroxyprogesterone Acetate; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride