{"analyses":[{"groupDescription":"Change in serum levels of Luteinizing hormone (LH) from baseline to week 1","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":">0.05","statisticalMethod":"Dunn Test"},{"groupDescription":"Change in serum levels of Luteinizing hormone (LH) from baseline to week 3","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":">0.05","statisticalMethod":"Dunn Test"},{"groupDescription":"Change in serum levels of Luteinizing hormone (LH) from baseline to week 8","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":">0.05","statisticalMethod":"Dunn Test"},{"groupDescription":"Change in serum levels of Luteinizing hormone (LH) from baseline to week 12","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.135","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.7","upperLimit":"2.8","value":"-0.6"},{"groupId":"OG001","lowerLimit":"-1.8","upperLimit":"8.1","value":"0.2"}]}],"title":"change from LH baseline to week 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.1","upperLimit":"3.5","value":"-0.5"},{"groupId":"OG001","lowerLimit":"-1.8","upperLimit":"7.7","value":"0.3"}]}],"title":"change from LH baseline to week 3"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.9","upperLimit":"3.1","value":"-0.3"},{"groupId":"OG001","lowerLimit":"-2.0","upperLimit":"6.0","value":"-1.3"}]}],"title":"change from LH baseline to week 8"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.3","upperLimit":"2.9","value":"-0.8"},{"groupId":"OG001","lowerLimit":"-1.6","upperLimit":"7.1","value":"1.3"}]}],"title":"change from LH baseline to week 12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Change from (mean screening-baseline) in plasma levels of LH to Week 1, Week 3, Week 8 and Week 12 in Serum Levels of LH 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\n\nestriol","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 women","reportingStatus":"POSTED","timeFrame":"Change from baseline to week 1, week 3, week 8 and week 12","title":"Variation in Serum Levels of Luteinizing Hormone (LH)","type":"SECONDARY","unitOfMeasure":"mIU/ml"}