| Disease | IN A DOUBLE-BLIND, RANDOMIZED, CONTROLLED STUDY, 30 WOMEN 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 ISOFLAVONE 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.OF 30 WOMEN, 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 ESTRADIOL LEVELS AT BASELINE AND POST-TREATMENT, AND ANALYSIS OF THESE SUBJECTS REVEALED NO DETECTABLE CHANGE IN THE RELATIONSHIP BETWEEN ESTRADIOL LEVELS AND KI-67 WITH TREATMENT IN EITHER GROUP. THERE WAS NO CHANGE IN
FASTING LIPIDS, BONE MARKERS, UTERINE DOPPLER RESISTANCE, OR PULSATILITY INDEX. |