Pharmaceutical formulations and uses thereof in the treatment of female sexual dysfunction

Abstract

The invention relates to the field of female sexual dysfunction. It specifically relates to the influence of the combination of testosterone or an analog thereof and tadalafil on sexual health in female subjects with Female Sexual Dysfunction (such as Female Sexual Arousal Disorder (FSAD) or Female Sexual Desire Disorder (FSDD)). It further relates to the influence of the combination of testosterone or an analog thereof and a compound capable of at least in part inhibiting smooth muscle constriction, for example a compound capable of at least in part inhibiting the adrenergic tone. The invention further discloses other combinatorial therapies in the treatment of Female Sexual Dysfunction.

1 . A method for treating female sexual dysfunction, the method comprising:
 administering to a female in need thereof a combination of testosterone or analog thereof and tadalafil, wherein said testosterone or analog thereof and tadalafil are released at essentially the same time or wherein said tadalafil is released prior to said testosterone or analog thereof and wherein said testosterone or analog thereof is provided such that there is a peak of testosterone or analog thereof in the blood circulation of the female to whom it is administered.   
     
     
         2 . A pharmaceutical composition comprising testosterone or an analog thereof and tadalafil
 (a) formulated so that the testosterone or analog and tadalafil are released at the same time, or formulated so that tadalafil is released prior to release of said testosterone or analog, and/or   (b) in a form wherein a peak concentration of said testosterone or analog in the blood is obtained.   
     
     
         3 . The pharmaceutical composition of  claim 2 , wherein said testosterone analog is dihydrotestosterone (DHT). 
     
     
         4 . The pharmaceutical composition of  claim 2 , wherein said testosterone or analog is formulated in a cyclodextrin-containing formulation and/or in a form for sublingual or buco-mucosal release. 
     
     
         5 . The pharmaceutical composition of  claim 2  comprising 0.3-25 mg of testosterone. 
     
     
         6 . The pharmaceutical composition of  claim 2  comprising 5-20 mg of tadalafil. 
     
     
         7 . The pharmaceutical composition of  claim 2  which is an oral formulation of tadalafil. 
     
     
         8 . (canceled) 
     
     
         9 . A kit of parts comprising:
 at least one pharmaceutical composition comprising testosterone or analog thereof in a form wherein a peak concentration of said testosterone or analog in the blood is obtained,   at least one pharmaceutical composition comprising tadalafil, and   instructions in respect to administering said pharmaceutical compositions.   
     
     
         10 . The kit of parts of  claim 9 , wherein said testosterone analog is dihydrotestosterone (DHT). 
     
     
         11 . The kit of parts of  claim 9 , wherein said testosterone or analog thereof is formulated in a cyclodextrin formulation. 
     
     
         12 . The kit of parts of  claim 9 , wherein the at least one pharmaceutical composition comprising testosterone or analog thereof comprises 0.3-25 mg of testosterone. 
     
     
         13 . The kit of parts of  claim 9 , wherein the at least one pharmaceutical composition comprising tadalafil comprises 5-20 mg of tadalafil. 
     
     
         14 . The kit of parts of  claim 9 , wherein the at least one pharmaceutical composition comprising tadalafil is an oral formulation of tadalafil. 
     
     
         15 . The kit of parts of  claim 9 , wherein the at least one pharmaceutical composition comprising testosterone or an analog thereof comprises a sublingual or buco-mucosal formulation of testosterone or an analog thereof. 
     
     
         16 . The composition of  claim 2 , which is in a form wherein a peak concentration of said testosterone or analog in the blood is obtained. 
     
     
         17 . The composition of  claim 2 , which is formulated so that the testosterone or analog and tadalafil are released at the same time or formulated so that tadalafil is released prior to the release of said testosterone or analog.