2.1. Design
Details of the two trials have been previously published [11, 12].
Two identical 90-day, randomized, double-blind, placebo-controlled trials of symptomatic menopausal women were conducted in Russia. The subjects were recruited by advertising at the research centers and doctors’ offices. Trial 1 was conducted from August 4, 2014 (first patient screened), to April 22, 2015 (last patient completed), and randomized 104 subjects to 3 sites. Trial 2 was conducted from August 5, 2015 (first patient screened), to January 29, 2016 (last patient completed), and randomized 125 subjects to 3 sites.
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The two trials were identical in design, protocol, randomization procedure, dosage, and trial procedures. In both trials, blood collection and clinical laboratory assays were done according to the same protocols, in the same laboratories, and on the same equipment. Both trials used the same version of the Greene Climacteric Scale and STAI questionnaires; the tests were administered in identical manner. All weight, height, and waist and hip circumference measurements were done with the same measuring techniques.
The 2014/2015 trial took place over summer, fall, winter, and spring, while the 2015/2016 trial was conducted over the course of summer, fall, and winter. The climacteric syndrome is not a seasonal pathology; thus, no correction coefficient was introduced in the pooled analysis. Since the two trials were identical in every aspect, the raw data could be pooled for analysis; meta-analysis coefficient is equal to one for all parameters.
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The trials enrolled symptomatic postmenopausal (12 months amenorrhea, STRAW + 10 classification [13]) women between 42 and 60 years with mild to moderate vasomotor and psychosomatic menopausal symptoms (Table 1). The total number of subjects in the pooled analysis was 114 in the treatment group (SBDS) and 113 in the control group (placebo). Two subjects in the placebo group from the first trial withdrew from the study due to medical causes unrelated to the intervention. None of the subjects withdrew from the second trial.
Subjects were excluded if any of the following were present at screening: oncological conditions, endocrinopathic conditions, psychiatric diseases, chronic somatic illnesses requiring therapies that could impact the trials’ outcomes (e.g., use of antidepressants for smoking cessation), use of hormonal therapies less than 6 months prior to the screening, or the use of dietary supplements or medications that could affect climacteric symptoms less than 1 month prior to enrolling in the trials.
The following information was collected from all subjects at study initiation: demographic data, general health information, and general and gynecological medical history. Anthropometric measurements (height, body weight, and waist and hip circumferences) and vital signs were recorded; subjects underwent general and gynecological exams. Standard laboratory evaluation included routine hematological and biochemical assays, urinalysis (Appendix A), mammogram, and ultrasound of lower pelvic organs. The complete schedule of procedures is shown in Table 2.
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