{"analyses":[{"groupDescription":"The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon.\n\nThe intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit.","groupIds":["OG000"],"nonInferiorityComment":"The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).","nonInferiorityType":"OTHER","pValue":"0.10","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupDescription":"The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.","groupIds":["OG001"],"nonInferiorityComment":"The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).","nonInferiorityType":"OTHER","pValue":"0.413","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.15","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-13.1","upperLimit":"7.4","value":"-2.8"},{"groupId":"OG001","lowerLimit":"-5.4","upperLimit":"15.7","value":"1.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)","dispersionType":"Inter-Quartile Range","groups":[{"description":"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration","id":"OG000","title":"0.005% Estriol Vaginal Gel"},{"description":"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration\n\nPlacebo","id":"OG001","title":"Placebo Vaginal Gel"}],"paramType":"MEDIAN","populationDescription":"postmenopausal participants","reportingStatus":"POSTED","timeFrame":"from baseline to 12 weeks of treatment","title":"Variation in Serum Levels of Follicle Stimulating Hormone (FSH)","type":"PRIMARY","unitOfMeasure":"mIU/ml"}