OBJECTIVE: To assess the effects of a red clover-derived @entity3093 extract on the Ki-67 proliferative marker of endometrial biopsies in 45-to 50-year-old perimenopausal @entity1 . We hypothesized that we would be able to detect a decrease in the Ki-67 proliferative index during the late follicular phase after a 3-month course of approximately 50 mg red clover @entity6400 . @entity6400 have been found to have some antiestrogenic effects, and an antiproliferative effect during the perimenopausal period may be especially useful owing to the excessive endometrial proliferation often characteristic of this period. DESIGN: In a double-blind, randomized, controlled study, 30 @entity1 between the ages of 45 and 50 years consented to an endometrial biopsy before and after a 3-month course of either placebo or active @entity3093 extract. The biopsies were timed as close as possible to days 7-11 of the menstrual cycle, and simultaneous measurements of transvaginal endometrial thickness, uterine artery Doppler, hormone profiles, lipids, and bone markers were performed. RESULTS: Of 30 @entity1 , 2 did not return for a second biopsy, and a third had an unsuccessful second biopsy. Four subjects were excluded from the Intention to Treat analysis because they did not have a menstrual bleed within the time frame of the study (3 subjects) or were tested on day 13 instead of between days 7 and 11 of the cycle (1 subject). There was no change in the Ki-67 proliferation index after treatment in either group. Eight subjects in the placebo group and eight in the P-07 group had proliferative endometrial biopsies that were synchronized with @entity53 levels at baseline and post-treatment, and analysis of these subjects revealed no detectable change in the relationship between @entity53 levels and Ki-67 with treatment in either group. There was no change in fasting lipids, bone markers, uterine Doppler resistance, or pulsatility index. CONCLUSION: In this small pilot study, we did not find, using immunohistochemical quantification of the Ki-67 antigen, that red clover @entity6400 had an antiproliferative effect in the endometrium. Small sample size, examination of a relatively short interval in the menstrual cycle, and @entity3093 formulation may have contributed to our lack of findings; however, we believe that the issue of @entity6400 and their possible antiproliferative effect is deserving of further study. A simpler physiological model with less hormonal variability, such as healthy, recently menopausal @entity1 on predetermined doses of @entity172 , may prove to be more informative.

A double-blind randomized study on the effects of red clover XXXX on the endometrium.

@entity1 :: ('9606', 'Species') :: ['women'] @entity172 :: ('MESH:D004967', 'Chemical') :: ['estrogen'] @entity3093 :: ('CHEBI:18220', 'Chemical') :: ['isoflavone'] @entity53 :: ('MESH:D004958', 'Chemical') :: ['estradiol'] @entity6400 :: ('MESH:D007529', 'Chemical') :: ['isoflavones', 'Isoflavones']
@entity6400 :: (MESH:D007529,Chemical) :: ['isoflavones']
