Method of treating men with testosterone supplement and 5alpha-reductase inhibitor

A technology of reductase inhibitors and supplements, a method applied to male patients with erectile dysfunction or erectile dysfunction, J.Neurochem. Field, can solve the problem of unsatisfactory implantation of artificial penis

Inactive Publication Date: 2008-03-19
MERCK & CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Until recently, only a small number of patients have been treated, as existing treatment options such as injection therapy, dildo implants and vacuum pumps have been unsatisfactory

Method used

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  • Method of treating men with testosterone supplement and 5alpha-reductase inhibitor
  • Method of treating men with testosterone supplement and 5alpha-reductase inhibitor
  • Method of treating men with testosterone supplement and 5alpha-reductase inhibitor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0288] Preparation of human prostate and scalp 5α-reductase

[0289] Human tissue samples were nebulized in a freeze grinder in 40 mM potassium phosphate (pH 6.5), 5 mM magnesium sulfate, 25 mM potassium chloride, 1 mM benzyl-sulfonyl fluoride, 1 mM dithiothreitol containing 0.25 M sucrose ( DTT) was homogenized with a Potter-Elvehjem homogenizer. The homogenate was centrifuged at 1,500 xg for 15 minutes to prepare a crude nuclear pellet. The crude pellet of pelleted nuclei was washed twice and resuspended in 2 volumes of buffer. Glycerol was added to the resuspended pellet to a final concentration of 20%. An aliquot of the enzyme suspension was frozen at -80°C. Prostate and scalp reductase is stable for at least 4 months when stored under these conditions. 5α-reductase assay

[0290] The reaction mixture of type 1 5α-reductase contains 40mM potassium phosphate (pH6.5), 5mM [7- 3 [H]-testosterone, 1 mM dithiothreitol, and 500 μM NADPH in a final volume of 100 μL. The reac...

Embodiment 2

[0297] Rat ex copula assay

[0298] In sexually mature male Caesarian Derived Sprague Dawley (CD) rats (>60 days old), the zonules were excised to prevent retraction of the penis into the penis sheath during external coitus assessment. Animals received food and water ad libitum and were maintained on a normal light / dark cycle. Study during photoperiod.

[0299] 1) Supine position braking (Restraint) conditioned reflex in external sexual intercourse reflex test. This conditioning was performed for ~4 days. On day 1, place the animal in a dark brake for 15-30 min. On day 2, animals were placed in the immobilizer in a supine position for 15-30 minutes. On day 3, animals were immobilized for 15-30 minutes in a supine position with the penile sheath retracted. On day 4, animals were immobilized in a supine position with penis sheath retracted until penile responses were observed. Some animals required additional days of conditioning before they fully adapted to the procedure...

Embodiment 3

[0305] in vivo experiment

[0306] In a 43-year-old male patient, the effects of a topical cream containing testosterone (T) alone versus a topical cream containing T plus finasteride were compared. On day 1, patients' total serum T and dihydrotestosterone (DHT) levels were measured at 11:30 a.m. On day 2, at 6:30 a.m., the patient applied a topical cream (10 grams) containing testosterone 1% (100 mg) to his chest, and the patient's T and DHT were measured again at 11:30 a.m. Level. The patient did not wash off the cream until the morning of the third day. On day 6, at 6:30 a.m. the patient applied a topical cream (10 g; same base as the cream for T alone) containing testosterone 1% (100 mg) + finasteride 50 mg to his chest, At 11:30 a.m. on the same day, the patient's T and DHT levels were measured again. The patient did not wash off the cream until the morning of the 7th day. As shown in Figures 1 and 2, total serum T and DHT were increased with the T-only topical cream...

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Abstract

A method of treating Alzheimer's disease, Parkinson's disease, sexual dysfunction or erectile dysfunction in a man by administration of a 5alpha reductase inhibitor together with a testosterone supplement is described. The method is also concerned with the use of the 5alpha reductase inhibiting compound and the testosterone supplement together with another agent useful for treating erectile dysfunction, including PDE V inhibitors; AGE (advanced glycation end-product) breakers; alpha 1 blockers; alpha 1A antagonists; alpha 2 antagonists; dopamine agonists; dopamine D4 agonists; melanocortin agonists; oxytocin agonists; prostaglandin; radical scavengers; rotamase inhibitors; aviptadil; nitroglycerine; and GPCR agonists for treating male sexual dysfunction or erectile dysfunction.

Description

Background of the invention [0001] Alzheimer's disease (AD) is the most common form of dementia. Although AD is a disease of old age, primarily affecting up to 10% of people over the age of 65, it also affects a significant number of younger patients with a genetic predisposition. It is a neurodegenerative disorder clinically characterized by progressive loss of memory and cognitive function and pathologically characterized by deposition of extracellular protein plaques in the cortex and associated brain regions of patients. These plaques mainly consist of fibrillar aggregates of β-amyloid (Aβ). While palliative treatments are currently available, there is no way to restore function in people with Alzheimer's disease. [0002] Parkinson's disease (PD) is a disease of middle-aged and elderly people with very slow progression and long course. The most common alteration in PD patients is the accumulation of melanin-containing neurons in the brainstem (substantia nigra, locus c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/435A61K31/568
CPCA61K31/568A61K31/58A61K45/06A61P15/00A61P15/10A61P25/00A61P25/16A61P25/24A61P25/28A61P39/06A61P43/00A61P5/28A61K2300/00
Inventor A·米汉
Owner MERCK & CO INC
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