title: Gender analysis of moxifloxacin clinical trials.
abstract: OBJECTIVE
  To determine the inclusion of women and the sex-stratification of results in moxifloxacin Clinical Trials (CTs), and to establish whether these CTs considered issues that specifically affect women, such as pregnancy and use of hormonal therapies. Previous publications about women's inclusion in CTs have not specifically studied therapeutic drugs. Although this type of drug is taken by men and women at a similar rate, adverse effects occur more frequently in the latter.
  
  
  METHODS
  We reviewed 158 published moxifloxacin trials on humans, retrieved from MedLine and the Cochrane Library (1998-2010), to determine whether they complied with the gender recommendations published by U.S. Food and Drug Administration Guideline.
  
  
  RESULTS
  Of a total of 80,417 subjects included in the moxifloxacin CTs, only 33.7% were women in phase I, in contrast to phase II, where women accounted for 45%, phase III, where they represented 38.3% and phase IV, where 51.3% were women. About 40.9% (n=52) of trials were stratified by sex and 15.3% (n=13) and 9% (n=7) provided data by sex on efficacy and adverse effects, respectively. We found little information about the influence of issues that specifically affect women. Only 3 of the 59 journals that published the moxifloxacin CTs stated that authors should stratify their results by sex.
  
  
  CONCLUSIONS
  Women are under-represented in the published moxifloxacin trials, and this trend is more marked in phase I, as they comprise a higher proportion in the other phases. Data by sex on efficacy and adverse effects are scarce in moxifloxacin trials. These facts, together with the lack of data on women-specific issues, suggest that the therapeutic drug moxifloxacin is only a partially evidence-based medicine.
authors.affiliation: 1 Public Health Research Group, University of Alicante , Alicante, Spain .
authors.forename: Elisa
authors.initials: E
authors.lastname: Chilet-Rosell
authors.forename: Ma Teresa
authors.initials: MT
authors.lastname: Ruiz-Cantero
authors.forename: Ma Angeles
authors.initials: MA
authors.lastname: Pardo
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001372:Aza Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D005260:Female; D024841:Fluoroquinolones; D019983:Guideline Adherence; D006801:Humans; D008297:Male; D000077266:Moxifloxacin; D011247:Pregnancy; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use*; D012737:Sex Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000077266:Moxifloxacin