Methods and compositions for modulating hormone levels

A method of treating a disease, disorder or condition by administering an effective amount of a selective androgen receptor modulator compound and an effective amount of an estrogen receptor modulator, or a pharmaceutically acceptable salt, ester or prodrug of the foregoing;

• and wherein the selective androgen receptor modulator is 4-(2(R)-(1(S)-hydroxy-2,2,2-trifluoroethyl)pyrrolidinyl)-2-trifluoromethyl-benzonitrile, or a pharmaceutically acceptable salt, ester or prodrug thereof;
• wherein the estrogen receptor modulator is lasofoxifene;
• and
• where the disease, disorder, or condition is selected from the group consisting of aging skin;
• Alzheimer's disease;
• an anemia;
• anorexia;
• arthritis;
• gout;
• arteriosclerosis;
• atherosclerosis;
• bone disease;
• bone damage;
• bone fracture;
• distraction osteogenesis;
• reduced bone mass, reduced bone density;
• reduced bone growth;
• bone weakening induced by glucocorticoid administration;
• musculoskeletal impairment (e.g., in the elderly);
• cachexia;
• breast cancer and osteosarcoma;
• cardiac dysfunction;
• myocardial infarction;
• cardiac hypertrophy;
• congestive heart failure;
• cardiomyopathy;
• catabolic side effects of glucocorticoids;
• Crohn's disease;
• growth retardation in connection with Crohn's disease;
• short bowel syndrome;
• irritable bowel syndrome;
• inflammatory bowel disease;
• ulcerative colitis;
• cognitive decline;
• cognitive impairment;
• dementia;
• short term memory loss;
• COPD;
• chronic bronchitis;
• decreased pulmonary function;
• emphysema;
• decreased libido in men;
• decreased libido in women;
• depression;
• nervousness, irritability and/or stress;
• reduced mental energy and low self-esteem (e.g., motivation/assertiveness);
• dyslipidemia;
• erectile dysfunction;
• frailty;
• age-related functional decline (“ARFD”) in the elderly;
• growth hormone deficiency;
• hematopoietic disorders;
• sex hormone deficiency (male and female);
• hyper-cholesterolemia;
• hyperinsulinemia;
• hyperlipidemia;
• hypertension;
• hyperandrogenemia;
• hypogonadism (including primary and secondary);
• hypothermia (including hypothermia following anesthesia);
• impotence;
• insulin resistance;
• type 2 diabetes;
• lipodystrophy;
• male menopause;
• metabolic syndrome (syndrome X);
• loss of muscle strength;
• loss of muscle strength function;
• muscular dystrophies;
• muscle loss following surgery;
• muscular atrophy;
• neurodegenerative diseases;
• neuromuscular disease;
• decreased platelet count;
• platelet aggregation disorders;
• obesity;
• osteoporosis;
• osteopenia;
• glucocorticoid-induced osteoporosis;
• osteochondrodysplasias;
• periodontal disease;
• premenstrual syndrome;
• postmenopausal symptoms in women;
• Reaven's syndrome;
• rheumatological disease;
• sarcopenia;
• male sexual dysfunction;
• female sexual dysfunction;
• erectile dysfunction;
• decreased sex drive;
• decreased libido;
• physiological short stature, including growth hormone deficient children and short stature associated with chronic illness and growth retardation associated with obesity;
• tooth damage;
• thrombocytopenia;
• vaginal dryness;
• atrophic vaginitis;
• ventricular dysfunction;
• and wasting.