Abstract 5071: Compounded Transdermal Hormone Therapy and Effects on Hemostatic and Immunologic Factors in Peri- and Post-Menopausal Women
Purpose: Perimenopausal and postmenopausal women have an increased risk of cardiovascular disease. Finding therapies to alleviate menopausal symptoms without increasing thrombotic risk is of clinical concern for the estimated population of 1.2 billion women worldwide by 2030. US female consumers are increasingly utilizing individualized hormone therapies prepared by a compounding pharmacist. The aim of this study was to evaluate the hemostatic and inflammatory effects of compounded transdermal estrogen, progesterone, and androgen therapy in peri/postmenopausal women.
Methods: 150 women (30 –70 years) were assigned to usual care or interventional group for 12 months. The interventional group was evaluated for sex steroid deficiencies, and transdermal estrogen, progesterone, testosterone, and dehydroandrostenidione were compounded and delivered transdermally to target reference ranges. Baseline, 2 month, and 12 month inflammatory and hemostatic mediators were measured.
Results: The hemostatic and inflammatory effect in the treatment arm was reflected by significant decreases from baseline at 12 months in: Fibrinogen (4.6 to 4.0 mg/ml, p = 0.004); Factor VII (1.1 to 0.9 μ g/ml, p < 0.001); and CRP (6.2 to 3.9 mg/ml, p = 0.023) with no significant changes observed in factor VIII (1.4 to 1.6 U/ml, p = 0.21); PAI-1 (9.7 to 6.0 IU/ml, p = 0.08); or IL-6 (1.1 to 0.2 pg/ml, p = 0.07). Clinical measures revealed significant decreases in: blood pressure (133 to 121 mmHg Systolic, p = 0.004); pulse pressure (52 to 45 mmHg, p = 0.016); fasting glucose (110 to 92 mEq/L, p < 0.001); fasting triglycerides (175 to 120 mg/dL, p < 0.001); Hamilton Depression/Anxiety Score (p < 0.001), Pain Score (p < 0.001), and Greene Climacteric Scale Score (p < 0.001). No significant differences in nutrition, stress, or BMI were noted.
Conclusion: This study demonstrates that compounded estrogen, progesterone, and androgens delivered transdermally in peri/postmenopausal women significantly relieve menopausal symptoms, and additionally provide an anti-inflammatory effect without increasing or adversely affecting thrombotic factors. Larger clinical trials are needed too determine whether this therapy is a good alternative to conventional hormone replacement therapy.