CH5424802 met the inclusion criteria were randomized to treatment

Tranexams acid. Second CH5424802 Methods 2.1. Study design and population This was a post hoc analysis of pooled data from two randomized, double-blind, controlled POSE against placebo studies conducted to assess the efficacy and safety of E2V/DNG for the treatment of severe, h Frequently and / or leasing Ngerten menstrual bleeding in women without organic cause. A study was conducted in the United States and Canada between December 2005 and May carried out in 2008, w While the other was conducted in Australia and Europe between February 2006 and May 2008. Both studies had identical designs have details of which already VER Published. In short, the two studies consisted of four parts: a screening phase of 28 days, a run of 90 days in phase, followed for a period of seven and one-cycle treatment period of 30 days. The women aged 18 years with the symptoms of a serious, engaged Ngerten menstrual bleeding and / or h More often without organic cause were eligible to participate in studies. Detailed information about the criteria for inclusion and exclusion and randomization procedures were previously VER Published. Because of the randomized and controlled It was with medroxyprogesterone acetate LNG-IUS with oral report conducted in women with HMB alone, this analysis to women who meet the criteria of the HMB Descr Nkt was made, women composed 84% of Bev Lkerung the study. HMB is as MBL 80 ml per cycle in at least two cycles of 28 days may need during the three 28-t Pendent cycles that make up along the defined period of this analysis. 2.2. Study treatments were 90 days after the race to stage the women who met the inclusion criteria were randomized to treatment with CO E2V/DNG or placebo for seven treatment cycles. Each treatment cycle of OC E2V/DNG estrogen delivered in a step down and progestin in one step as follows: E2V 3 mg on days 1 and 2, 2 mg E2V / 2 mg DNG Day 3 7, 2 mg E2V / 3 DNG mg on days 8, 24 1 mg of E2V on days 26 and 25 placebo at day 27 28 The study medication began the first day of bleeding after randomization, and there were no days of tablet-free trade between treatment cycles. 2.3. phone start-up study estimates for the duration of the study were women only need to use the elements of health by the sponsor. In addition, they had the electronic diaries on a t Adjusted based on menstrual bleeding, the number and type of elements of health and drug study w Documented during treatment abzuschlie S. In addition to meeting the organizer was required of women to all elements of the sanitary To collect r protection for an objective analysis of the MBL with a modified alkaline H Matin method. 2.4. Study end points for this post-hoc analysis, summarized, were the most important variable efficacy of the Absolute Ver Change from baseline to 7 MBL treatment cycle, the proportion of women who were successfully treated mL, the proportion of women with MBL at 80 and proportion of women who experienced a 50% reduction in MBL base. In the original studies, the treatment was successful in a period of 90 days and evaluated for free defined with a composite of eight different criteria. 2.5. Statistical analyzes were performed using the ITT population, ie all randomized women. W While the original studies were bleedi in women with heavy menstrual bleeding, h INDICATIVE and / or leasing Ngerten performed.

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