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

Abstract

The present invention relates to the use of a combination of a PDE5-inhibitor and testosterone for the preparation of a medicament for the treatment of Female Sexual Dysfunction.

1 . A kit of parts consisting essentially of a set of instructions for treating a sexual disorder in a female, a first pharmaceutical composition comprising testosterone or dihydrotestosterone (DHT), wherein said first pharmaceutical composition is provided in the form of a sublingual formulation further comprising cyclodextrin and is designed to release all of the testosterone or DHT essentially immediately,
 and a second pharmaceutical composition comprising a PDE5-inhibitor, wherein said second composition is designed for immediate release of said PDE5-inhibitor, and wherein said instructions direct a subject to administer the second composition 1.5-4.5 hours after administering the first composition.   
     
     
         2 . The kit of parts of  claim 1 , wherein the first pharmaceutical composition comprises from 0.3 mg testosterone to 2.5 mg testosterone. 
     
     
         3 . The kit of parts of  claim 1 , wherein the second pharmaceutical composition comprises from 5 mg to 20 mg vardenafil. 
     
     
         4 . The kit of parts of  claim 1 , wherein the second pharmaceutical composition comprises from 25 mg to 100 mg sildenafil. 
     
     
         5 . The kit of parts of  claim 1 , wherein the second pharmaceutical composition comprises from 5 mg to 20 mg tadalafil. 
     
     
         6 . The kit of parts of  claim 1 , further comprising a compound competing with testosterone for sex hormone binding globulin (SHBG) binding. 
     
     
         7 . The kit of parts of  claim 1 , wherein said testosterone or DHT provides a peak level in the patient's blood circulation of free testosterone or DHT of at least 0.010 nmol/l. 
     
     
         8 . A method of treating a sexual disorder in a female, said method comprising:
 administering the kit of parts of  claim 1  to a female suffering from said sexual disorder.   
     
     
         9 . A pharmaceutical formulation comprising testosterone or DHT and a PDE5 inhibitor, wherein said testosterone provides a peak level in the patient's blood circulation of free testosterone or DHT of at least 0.010 nmol/l.