Effects of bazedoxifene/conjugated estrogens on reproductive endocrinology and reproductive tract ultrasonographic appearance in premenopausal women: a preliminary study

Bazedoxifene (BZA) paired with conjugated estrogens (CE) is the first tissue selective estrogen receptor complex (TSEC) approved by the United States Food and Drug Administration for the treatment of menopausal symptoms. Clinical trials in menopausal women and in premenopausal murine models of endometriosis have demonstrated safety and efficacy, however, the impact of BZA/CE on premenopausal women is not known. Here we report a case series study in premenopausal women assessing effects of BZA/CE on reproductive hormones, and uterine/ovarian ultrasonographic appearance. After one monitoring cycle, five subjects underwent daily administration of BZA/CE (20 mg/0.45 mg) for 12 weeks, and were followed for 4 weeks after treatment. Uterine/ovarian morphology was assessed with ultrasound, and endocrinologic function with ovulation prediction kits and serum assessment of reproductive hormones throughout the menstrual cycle. All subjects demonstrated an LH surge on the medication; interestingly there was a significant decrease in luteinizing hormone level during treatment compared to posttreatment values. BZA/CE was well-tolerated in premenopausal women and did not induce clinically relevant reproductive hormone changes, endometrial alterations, or abnormal ovarian folliculogenesis.