Use of testosterone and a 5-ht1a agonist in the treatment of sexual dysfunction

Abstract

The invention relates to the field of male and/or female sexual dysfunction. The invention specifically relates to the use of testosterone and a 5-HT1A agonist.

1 . A pharmaceutical composition designed for acute administration in anticipation of sexual activity comprising testosterone or analog thereof and a 5-HT1A agonist, wherein said testosterone or analog is formulated for immediate release and the 5-HT1A agonist is formulated for delayed release such that 5-HT1A is released 2.5 to 4.5 hours after the release of testosterone or analog. 
     
     
         2 . The pharmaceutical composition of  claim 1  which further includes a PDE5 inhibitor, wherein said composition is formulated for delayed release of said PDE5 inhibitor 1.5-4.5 hours after the release of testosterone or analog. 
     
     
         3 . The pharmaceutical composition of  claim 3 , wherein the testosterone or analog is testosterone. 
     
     
         4 . The pharmaceutical composition of  claim 3 , wherein the composition comprises between 0.3 mg and 2.5 mg testosterone. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the 5-HT1A agonist is buspirone. 
     
     
         6 . The pharmaceutical composition of  claim 1  which is a nasal, sublingual or buccal-mucosal formulation. 
     
     
         7 . The pharmaceutical composition of  claim 6  which is a sublingual formulation. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein said delayed release is effected by surrounding the 5-HT1A agonist by a coating. 
     
     
         9 . A kit comprising at least one pharmaceutical composition comprising testosterone or analog thereof formulated for immediate release of said testosterone and at least one pharmaceutical composition comprising a 5-HT1A agonist formulated for immediate release, wherein said kit further comprises instructions to administer said compositions acutely in anticipation of sexual activity at a time so that testosterone or analog is released 3.5-5 hours prior to sexual activity and the 5-HT1A agonist is released 1 hour prior to sexual activity. 
     
     
         10 . The kit of  claim 9  further comprising at least one pharmaceutical composition comprising a PDE5 inhibitor along with instructions to administer said PDE5 inhibitor at a time so that it is released 1-2 hours prior to sexual activity. 
     
     
         11 . The kit of  claim 9 , wherein the 5-HT1A agonist is buspirone. 
     
     
         12 . The kit of  claim 9 , wherein the testosterone or analog is testosterone. 
     
     
         13 . The kit of  claim 12 , wherein the testosterone composition comprises between 0.3 mg and 2.5 mg testosterone. 
     
     
         14 . A method to treat sexual dysfunction in anticipation of sexual activity, which method comprises providing to a subject in need of such treatment an effective amount of testosterone or an analog thereof followed by providing said subject with a 5-HT1A agonist 2.5-4.5 hours after the testosterone or analog is provided. 
     
     
         15 . The method of  claim 14 , wherein said testosterone or an analog thereof is formulated for sublingual, buccal-mucosal, or intranasal administration with a cyclodextrin. 
     
     
         16 . The method of  claim 14 , wherein the testosterone analog is dihydrotestosterone. 
     
     
         17 . The method of  claim 14 , wherein the 5-HT1A agonist is buspirone. 
     
     
         18 . The method of  claim 14 , wherein the testosterone or an analog and the 5-HT1A agonist are provided in single formulation. 
     
     
         19 . The method of  claim 15 , wherein the testosterone or an analog is formulated to be released in one short burst 60-120 seconds after administration. 
     
     
         20 . The method of  claim 17 , wherein the testosterone or analog is testosterone.