Bioidentical Hormone Replacement Therapy at a Hormone Clinic Causing Significant Virilization in a Post-Menopausal Women

Abstract

\n Introduction: Bioidentical hormones (BH) are compounds that have the exact chemical and molecular composition as hormones produced in our bodies. The term typically refers to testosterone, progesterone, and androgens. Compounding pharmacies market these products as being individually tailored, safer, and more effective than modified hormones synthesized under FDA supervision. These compounded products are not subject to FDA approval for dose, purity, safety, or efficacy, which poses a risk to patients. Our case highlights the dangers of unmonitored BH replacement therapy (BHRT) use and the importance of patient education regarding these products.\n Clinical Case: A 48 year-old woman presented to our clinic for evaluation of elevated testosterone levels. She underwent a total hysterectomy and bilateral oophorectomies 8 years prior for heavy menses. She was briefly placed on estradiol replacement which was discontinued due to tobacco abuse. She presented to a “hormone clinic” where she was told that her testosterone levels were low and was started on BHRT pellets. The composition of these pellets were not disclosed on the manufacturer’s website. They were to be inserted every 3 months. The patient had received two pellet insertions prior to her initial visit.\n The patient reported feeling miserable with nausea, headaches, hot flashes, severe hirsutism, hair loss, severe aggression, increased libido, and clitoromegaly (the size of a ping-pong ball). Physical exam was notable for hirsutism of the upper lip, cheeks, and chin. No obvious foreign objects were identified in the buttocks. Genital exam was declined. Lab results prior to pellet insertion showed: total testosterone 6 ng/dL (N: 8-60 ng/dL), FSH 96.4 mU/ml (post-menopausal: 20-100 mU/ml) and estradiol < 5 pg/mL (post-menopausal < 41 pg/mL). After the initial pellet insertion: total testosterone 320 ng/dL, FSH 85.3 mU/mL, and estradiol 36.2 pg/mL. Five months after the second pellet insertion, total testosterone was 112 ng/dL, DHEAS 15.2 ug/dL (N: 35.4-256.0 ug/dL), FSH 74.9 mU/mL, and estradiol 46 pg/mL. Ultrasound of the buttocks revealed 1 ovoid hypoechoic structure in each buttock.\n The patient underwent surgical removal of the pellets. Post-procedural total testosterone was < 12 ng/dL (N < 40 ng/dL). Her aggression and hirsutism improved, but libido became low and clitoromegaly remained unchanged.\n Conclusion: The misunderstanding that BHRT is safer and more effective than synthesized, FDA-regulated hormones can lead to harmful adverse effects as seen in our patient with significant signs and symptoms of virilization. Patient education regarding the safety and efficacy of unregulated use of these compounds is crucial along with heightened physician awareness for appropriate patient guidance.