METHODS OF TREATING TESTOSTERONE DEFICIENCY
Methods of treating a testosterone deficiency or its symptoms with a pharmaceutical formulation of testosterone undecanoate are provided.
1 . A method of treating conditions associated with a deficiency or absence of endogenous testosterone in a subject in need thereof comprising the steps of:
administering to the subject a defined dose of an oral pharmaceutical composition comprising testosterone undecanoate solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant, wherein the defined dose is 237 mg administered twice daily;
collecting a blood sample from the subject;
measuring the serum testosterone concentration in the subject; and
increasing the dose of testosterone undecanoate to 316 mg, administered twice daily, when the measured serum testosterone concentration in the subject is less than about 425 ng/dL,
decreasing the dose of testosterone undecanoate to 198 mg, administered twice daily, when the measured serum testosterone concentration in the subject is greater than about 970 ng/dL, or
maintaining the dose of testosterone undecanoate when the measured serum testosterone concentration in the subject is between about 425 ng/dL and about 970 ng/dL.
2 . The method of claim 1 , wherein the serum testosterone concentration is measured four to eight hours after administering the oral pharmaceutical composition.
3 . The method of claim 1 , wherein the oral pharmaceutical composition comprises about 19.8 percent by weight of solubilized testosterone undecanoate, about 51.6 percent by weight of oleic acid, and about 16.1 percent by weight of polyoxyethylene (40) hydrogenated castor oil.
4 . The method of claim 3 , wherein the oral pharmaceutical composition further comprises about 10 percent by weight of borage seed oil and about 2.5 percent by weight of peppermint oil.
5 . The method of claim 1 , wherein the testosterone concentrations are measured in serum from a blood sample collected in a plain tube drawn 5-7 hours after the morning dose and at least 7 days after starting treatment and following dose adjustment.
6 . The method of claim 1 , wherein the subject is diagnosed with hypogonadal conditions associated with structural or genetic etiologies.
7 . The method of claim 1 , wherein the subject is diagnosed with primary hypogonadism.
8 . The method of claim 1 , wherein the subject is diagnosed with testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
9 . The method of claim 1 , wherein the subject is diagnosed with hypogonadotropic hypogonadism.
10 . The method of claim 9 , wherein the subject is diagnosed with gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
11 . The method of claim 1 , wherein the subject is not diagnosed with age-related hypogonadism.
12 . The method of claim 1 , wherein prior to administering the defined dose of an oral pharmaceutical composition, further comprising the step of confirming the diagnosis of hypogonadism.
13 . The method of claim 12 , wherein the diagnosis of hypogonadism is confirmed if the serum testosterone concentrations measured on at least two separate days are below the normal range.
14 . A method of treating conditions associated with a deficiency or absence of endogenous testosterone in a subject in need thereof comprising the steps of:
administering to the subject a defined dose of an oral pharmaceutical composition comprising testosterone undecanoate solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant, wherein the defined dose is 316 mg administered twice daily;
collecting a blood sample from the subject;
measuring the serum testosterone concentration in the subject; and
increasing the dose of testosterone undecanoate to 396 mg, administered twice daily, when the measured serum testosterone concentration in the subject is less than about 425 ng/dL,
decreasing the dose of testosterone undecanoate to 237 mg, administered twice daily, when the measured serum testosterone concentration in the subject is greater than about 970 ng/dL, or
maintaining the dose of testosterone undecanoate when the measured serum testosterone concentration in the subject is between about 425 ng/dL and about 970 ng/dL.
15 . The method of claim 14 , wherein the serum testosterone concentration is measured four to eight hours after administering the oral pharmaceutical composition.
16 . The method of claim 14 , wherein the oral pharmaceutical composition comprises about 19.8 percent by weight of solubilized testosterone undecanoate, about 51.6 percent by weight of oleic acid, and about 16.1 percent by weight of polyoxyethylene (40) hydrogenated castor oil.
17 . The method of claim 16 , wherein the oral pharmaceutical composition further comprises about 10 percent by weight of borage seed oil and about 2.5 percent by weight of peppermint oil.
18 . The method of claim 14 , wherein the testosterone concentrations are measured in serum from a blood sample collected in a plain tube drawn 5-7 hours after the morning dose and at least 7 days after starting treatment and following dose adjustment.
19 . The method of claim 14 , wherein the subject is diagnosed with hypogonadal conditions associated with structural or genetic etiologies.
20 . The method of claim 14 , wherein the subject is diagnosed with primary hypogonadism.
21 . The method of claim 14 , wherein the subject is diagnosed with testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
22 . The method of claim 14 , wherein the subject is diagnosed with hypogonadotropic hypogonadism.
23 . The method of claim 22 , wherein the subject is diagnosed with gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
24 . The method of claim 14 , wherein the subject is not diagnosed with age-related hypogonadism.
25 . The method of claim 14 , wherein prior to administering the defined dose of an oral pharmaceutical composition, further comprising the step of confirming the diagnosis of hypogonadism.
26 . The method of claim 25 , wherein the diagnosis of hypogonadism is confirmed if the serum testosterone concentrations measured on at least two separate days are below the normal range.