MON-LB002 Compounded Testosterone Preparations Raise Testosterone Levels to Premenopausal Ranges in Postmenopausal Women With Hypo-Sexual Desire Disorder (HSDD)

Introduction Testosterone (T) in women declines with age. T levels cannot differentiate women with or without HSDD. T therapy approximating upper physiologic premenopausal levels improves all domains of sexual desire, libido, and decreases sexual distress(1,2). As of 2020, there are no FDA-approved T preparations for women. Male preparations of T are frequently used off-label to treat HSDD. No peer-reviewed data exists on T levels achieved with compounded testosterone preparations from a single reliable source. This study assesses efficacy of four compounded T preparations to raise T levels, using typically recommended doses. T was obtained from a single Pharmacy Compounding Accreditation Board (PCAB)-certified pharmacy. Methods Twenty-six matched baseline and post-treatment T levels were obtained as part of standard care for post-menopausal women (age 61±6 years) 3 months after being prescribed T for HSDD. T was obtained from the Women’s International Pharmacy. T doses were 0.5-2.0 mg/day, 6 days a week, using 4 methods of administration based on patient’s preferences: 1) cutaneous cream to skin (CS) behind the knees (n=12); 2) intravaginal suppositories (IVS) (n=5); 3) intravaginal oil-capsules (IVoil-C) (n=7); and 4) vulvar cream (VC) (n=2). Mean T dose was 1.5±0.6 mg/day. All patients gave consent for use of their T data, and were compliant with treatment for a week prior to testing. Measures of total T were performed by MS/LC, and of free T by equilibrium dialysis. Normal ranges for total T is 15-70 ng/dl and free T is 0.5-6.5 pg/ml. Paired T-tests comparisons between baseline and treatment values where done within each group where n was sufficient. (*p<0.05, **p<0.01). Results: Baseline and treatment total T (ng/dl) were 18.3±3.6 and 55.3±5.2** for CS, 19.8±4.3 and 56.6±15.9 for IVS (p=NS), 23.0±3.2 and 89.2±23* for IVoil-C, and 25.0±3.0 and 182±47 for VC. Baseline and treatment free T (pg/ml) were 1.18±0.26 and 4.16±0.6** for CS, 1.12±0.2 and 3.46±1.3 for IVS, 1.60±0.2 and 5.95±1.2* for IVoil-C, and 1.36±0.4 and 9.45±1.2 for VC. Testosterone administration by CS or IVoil-C significantly increased testosterone levels to the upper normal premenopausal range in women with HSDD. Conclusion Treatment of HSDD in postmenopausal women with compounded T via CS or IVoil-C, at doses of 0.5-2.0 mg, effectively raises T levels to upper premenopausal range. Vaginal oil capsules may be particularly useful in avoiding accidental hormone contact by other household members. A FDA-approved form of T replacement would be a welcome treatment for women with HSDD. 1. Islam RM et al. Lancet Diabetes-Endocrinology (7):754-66, 2019. 2. Davis SR. Climacteric, 22:5,429-434, 2019.