No trends or clinically meaningful changes were identified in the women's laboratory blood or urine tests, hormone levels, electrocardiographs, physical examinations or vital signs. The trial investigators noted treatment-emergent adverse effects in participants of all the treatment groups. Such effects occurring in more than 10 percent of any S-equol group included abdominal distention (eight women) and endometrial hypertrophy (three women), the thickening of the lining of the uterus. The endometrial hypertrophy was identified by transvaginal ultrasounds and was assessed by the Medical Monitor; any changes observed were not considered to be clinically significant.
Of note, Jenks explained, endometrial hypertrophy developed in three women in the 10 mg S-equol group but only one and none in the 20 mg and 40 mg S-equol groups, respectively, which suggest that S-equol does not affect endometrial hypertrophy. Moreover, gastrointestinal disorders in the seven women in both 10 mg and 20 mg S-equol groups as well as the one in the 40 mg S-equol and two in the isoflavone groups, may have resulted from the naturally occurring dietary fiber in the fermented soy germ-based nutritional supplement containing S-equol and from the lactose in the placebo tablets used to match the total number of tablets in each group.
At enrollment, the women had not experienced a menstrual period in the previous 12 months and their levels of follicle stimulating hormone
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