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ONE-AND TWO-POINT TITRATION METHODS TO DETERMINE DAILY TREATMENT REGIMENS TO TREAT HYPOGONADISM OR MALE TESTOSTERONE DEFICIENCY WITH AN INTRANASAL TESTOSTERONE BIO-ADHESIVE GEL, AND PRIMARY AND SECONDARY EFFICACY AND SAFETY ENDPOINTS
ONE-AND TWO-POINT TITRATION METHODS TO DETERMINE DAILY TREATMENT REGIMENS TO TREAT HYPOGONADISM OR MALE TESTOSTERONE DEFICIENCY WITH AN INTRANASAL TESTOSTERONE BIO-ADHESIVE GEL, AND PRIMARY AND SECONDARY EFFICACY AND SAFETY ENDPOINTS
The present invention relates to 4.0% and 4.5% intranasal testosterone bio- adhesive gels for providing sustained intranasal delivery of testosterone to a male and intranasal treatment methods for safely providing sustained release testosterone to treat males with hypogonadism. In particular, the present invention relates to improved testosterone replacement therapy (TRT) and sustained intranasal testosterone gel formulations for treating male hypogonadism. The 4.0% and 4.5% intranasal testosterone bio-adhesive gels are effective, are statistically significant regarding improvement in effect on erectile function and mood, provide for favourable trends for effect on body composition and bone mineral density and have safety measures after 360 days of treatment that are consistent with currently marketed topical testosterone products. The present invention also relates to a system for dispensing intranasally a precise dosage amount of such gels in smaller volumes at an optimal anatomical location within each nostril of the male, so that an effective amount of testosterone is deposited within each nostril at the optimal anatomical location for TRT, including to effectively treat testosterone deficiency in male subjects, such as hypogonadism. The present invention is also concerned with a novel titration method to determine the appropriate daily treatment regimen, i.e., a BID or TID treatment regimen, to administer the intranasal gels of the present invention to treat hypogonadism or TRT. The present invention is also concerned with novel titrations method to determine the appropriate daily treatment regimen, i.e., a QD, BID or TID treatment regimen, to administer the intranasal gels of the present invention to treat hypogonadism or TRT in males. In particular, the present testosterone therapy remains effective for treating hypogonadism when an allergic rhinitis event occurs in the male or when the male subject uses a topical nasal vasoconstrictor or a topical intranasal decongestant during the hypogonadism treatment. Further, the present invention relates to a novel method of preventing the occurrence of an allergic rhinitis event in a male, who is undergoing a hypogonadism treatment with an intranasal testosterone bio-adhesive gel formulation. In certain embodiments, the intranasal testosterone bio-adhesive gel formulation according to the invention comprises 4.0% and 4.5% testosterone.
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