title: Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder.
abstract: BACKGROUND
  The study was conducted to investigate continuous daily levonorgestrel 90 mcg/ethinyl estradiol 20 mcg (LNG/EE) on premenstrual dysphoric disorder (PMDD).
  
  
  METHODS
  In this multicenter, randomized, double-blind, placebo-controlled study, women with PMDD received LNG/EE (n=186) or placebo (n=181) daily for 112 days and completed the Daily Record of Severity of Problems (DRSP).
  
  
  RESULTS
  Mean DRSP change from baseline to late luteal phase was significantly greater with LNG/EE than placebo at the late luteal phase of the first estimated cycle (-30.52±1.73 [SE] vs. -22.47±1.77; p<.001) and the worst 5 days during the last on-therapy estimated cycle (-26.77±1.83 vs. -20.89±1.82; p=.016). Other primary end points were not statistically significant. Significantly more subject taking LNG/EE (52%) than placebo (40%) responded (≥50% improvement in the DRSP 7-day late luteal phase score and Clinical Global Impression of Severity score of ≥1 improvement) at last on-therapy cycle (p=.025).
  
  
  CONCLUSIONS
  Continuous daily LNG 90 mcg/EE 20 mcg was well tolerated and may be useful for managing the physical, psychological and behavioral symptoms and loss of work productivity related to PMDD.
authors: Department of Psychiatry, University of Buffalo (SUNY-AB), Buffalo, NY 14214, USA. urielh@buffalo.edu
authors: Uriel
authors: U
authors: Halbreich
authors: Ellen W
authors: EW
authors: Freeman
authors: Andrea J
authors: AJ
authors: Rapkin
authors: Lee S
authors: LS
authors: Cohen
authors: Gary S
authors: GS
authors: Grubb
authors: Richard
authors: R
authors: Bergeron
authors: Lynne
authors: L
authors: Smith
authors: Sebastian
authors: S
authors: Mirkin
authors: Ginger D
authors: GD
authors: Constantine
mesh_terms: D000293:Adolescent; D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D004967:Estrogens; D004997:Ethinyl Estradiol; D016912:Levonorgestrel