Results: After 6 months, 42% of genistein aglycone-administered subjects had a significant improvement of symptoms (histologically confirmed in the 29%) compared to 47% of norethisterone acetate subjects (histologically confirmed in the 31%), but only 12% in the placebo group with 19% exhibiting worsening symptoms and increased endometrial thickness.
One group (19 subjects) was treated with norethisterone acetate (10mg/day throughout days 16-25 of menstruation).
1) showed similar characteristics regarding age (placebo = 46.9[+ or -]2 years; genistein= 47.2[+ or -]3.1 years; norethisterone acetate=47.2 [+ or -]3.4 years), body mass index (placebo = 24 [+ or -] 0.6; genistein = 24 [+ or -] 1.1; norethisterone acetate = 23.5[+ or -]1.5), parity (placebo= 1.5 [+ or -]2; genistein = 1.3[+ or -]1.2; norethisterone acetate =1.2 [+ or -] 1.1) and endometrial thickness (placebo = 6.5 [+ or -] 2.2 mm; genistein = 7 [+ or -] 3 mm; norethisterone acetate = 7 [+ or -] 2.6 mm) evaluated at days 8-10 of menstruation.
Histologically, only six subjects (out of 9) showed a complete regression of hyperplasia when treated with norethisterone acetate.
A non-parametric test showed a significant decrease (p < 0.05) of symptoms in both genistein and norethisterone acetate groups compared to placebo after 6 months (Fig.
Receptor status was evaluated in endometrial specimens collected from all subjects at the beginning and at the end of the trial in order to understand the impact of genistein administration versus norethisterone acetate treatment on molecular expression of ER and PR.