title: An overview of four studies of a continuous oral contraceptive (levonorgestrel 90 mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual syndrome.
abstract: BACKGROUND
  This article presents an overview of four studies that evaluated a continuous oral contraceptive (OC) containing levonorgestrel (90 mcg) and ethinyl estradiol (20 mcg; LNG/EE) for managing premenstrual dysphoric disorder (PMDD) and premenstrual syndrome (PMS).
  
  
  METHODS
  Three randomized, double-blind, placebo-controlled trials and one open-label, single-treatment substudy examined mean changes from baseline in the Daily Record of Severity of Problems (DRSP) or Penn Daily Symptom Rating (DSR).
  
  
  RESULTS
  Improvements from baseline in mean DRSP and DSR scores were observed, but results were not consistent among the studies. Mean percent improvement of premenstrual symptoms ranged from 30% to 59% in controlled trials and 56% to 81% in an open-label substudy. A large placebo effect was also observed in the placebo-controlled studies. Continuous LNG/EE yielded a favorable safety profile.
  
  
  CONCLUSIONS
  These data, although not consistent, indicate that continuous LNG/EE may reduce the symptoms of PMDD and PMS, providing an option for women who are appropriate candidates for a continuous OC as a contraceptive, the approved indication for this medication.
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania Medical Center, Philadelphia, PA 19104, USA. freemane@mail.med.upenn.edu
authors.forename: Ellen W
authors.initials: EW
authors.lastname: Freeman
authors.forename: Uriel
authors.initials: U
authors.lastname: Halbreich
authors.forename: Gary S
authors.initials: GS
authors.lastname: Grubb
authors.forename: Andrea J
authors.initials: AJ
authors.lastname: Rapkin
authors.forename: Sven O
authors.initials: SO
authors.lastname: Skouby
authors.forename: Lynne
authors.initials: L
authors.lastname: Smith
authors.forename: Sebastian
authors.initials: S
authors.lastname: Mirkin
authors.forename: Ginger D
authors.initials: GD
authors.lastname: Constantine
mesh_terms: D000928:Antidepressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003866:Depressive Disorder / Q000188:drug therapy*; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015990:Placebo Effect; D011293:Premenstrual Syndrome / Q000188:drug therapy* / Q000523:psychology
chemical_list: D000928:Antidepressive Agents; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C072593:ethinyl estradiol, levonorgestrel drug combination; D004997:Ethinyl Estradiol; D016912:Levonorgestrel