{"analyses":[{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.08","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.48","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4","upperLimit":"1","value":"-2"},{"groupId":"OG001","lowerLimit":"-4","upperLimit":"1","value":"-2"},{"groupId":"OG002","lowerLimit":"-4","upperLimit":"1","value":"-1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"118"}],"units":"Participants"}],"description":"The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1=\"none\", 2=\"mild\", 3=\"moderate\", 4=\"severe\" and 5=\"very severe\" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).","dispersionType":"Full Range","groups":[{"description":"Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \\[DHEA\\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.","id":"OG000","title":"Arm I Low Dose DHEA"},{"description":"Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.","id":"OG001","title":"Arm II High Dose DHEA"},{"description":"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.\n\nThere is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.","id":"OG002","title":"Arm III Placebo"}],"paramType":"MEDIAN","populationDescription":"All patients that started treatment and completed their week 12 evaluation are included in this analysis.","reportingStatus":"POSTED","timeFrame":"At baseline and 12 weeks","title":"Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks","type":"PRIMARY","unitOfMeasure":"change in units on a scale"}