Treatment of female sexual dysfunction

Abstract

Methods and formulations for treating female sexual dysfunction are provided. A pharmaceutical composition formulated so as to contain a selected vasoactive agent is administered to the vagina, vulvar area or urethra of the individual undergoing treatment. Suitable vasoactive agents are vasodilators, including naturally occurring prostaglandins, synthetic prostaglandin derivatives, endothelial-derived relaxation factors, vasoactive intestinal polypeptide agonists, smooth muscle relaxants, leukotriene inhibitors, and others. The formulations are also useful for preventing the occurrence of yeast infections, improving vaginal muscle tone and tissue health, enhancing vaginal lubrication, and minimizing excess collagen deposition. A clitoral drug delivery device is also provided.

We claim:  
     
         1 . A pharmaceutical formulation for treating sexual dysfunction in a female individual and suitable for vaginal administration and/or application to the vulvar region, comprising a prostaglandin and an androgenic agent in amounts effective to treat female sexual dysfunction, and a pharmaceutically acceptable carrier suited to vaginal and/or vulvar drug delivery, wherein the prostaglandin is selected from the group consisting of naturally occurring prostaglandins, semisynthetic prostaglandin derivatives, synthetic prostaglandin derivatives, pharmacologically acceptable salts, esters, and inclusion complexes thereof, and combinations of any of the foregoing, and (b) an androgenic agent.  
     
     
         2 . The pharmaceutical formulation of  claim 1 , wherein the prostaglandin is a naturally occurring prostaglandin or a hydrolyzable lower alkyl ester thereof.  
     
     
         3 . The pharmaceutical formulation of  claim 2 , wherein the naturally occurring prostaglandin is selected from the group consisting of PGE 0 , PGE 1 , PGA 1 , PGB 1 , PGF 1 , 19-hydroxy-PGA 1 , 19-hydroxy-PGB 1 , PGE 2 , PGA 2 , PGB 2 , 19-hydroxy-PGA 2 , 19-hydroxy-PGB 2 , PGE 3 , PGF 3  and PGI 2 , hydrolyzable lower alkyl esters thereof, and combinations of any of the foregoing.  
     
     
         4 . The pharmaceutical formulation of  claim 1 , wherein the prostaglandin is a synthetic prostaglandin derivative or a hydrolyzable lower alkyl ester thereof.  
     
     
         5 . The pharmaceutical formulation of  claim 4 , wherein the synthetic prostaglandin derivative is selected from the group consisting of carboprost tromethamine, dinoprost tromethamine, dinoprostone, gemeprost, metenoprost, sulprostone and tiaprost.  
     
     
         6 . The pharmaceutical formulation of  claim 1 , wherein the vasoactive agent is PGE, and the androgenic agent is selected from the group consisting of testosterone, 5-dihydrotestosterone, and pharmaceutically acceptable esters thereof.  
     
     
         7 . The pharmaceutical formulation of  claim 1 , comprising an ointment, cream, gel, solid, solution, suspension, foam or liposomal composition.  
     
     
         8 . The pharmaceutical formulation of  claim 6 , comprising an ointment, cream, gel, solid, solution, suspension, foam or liposomal composition.  
     
     
         9 . The pharmaceutical formulation of  claim 1 , wherein the formulation is contained within a vaginal ring, tampon, suppository, sponge, pillow, puff, or osmotic pump system.  
     
     
         10 . The pharmaceutical formulation of  claim 6 , wherein the formulation is contained within a vaginal ring, tampon, suppository, sponge, pillow, puff, or osmotic pump system.