Methods, compositions, and kits for enhancing female sexual desire and responsiveness

Abstract

Topical application of a prostaglandin directly to the clitoris is effective for enhancing female sexual desire and responsiveness.

We claim:  
     
         1 . A pharmaceutical composition for topical administering to the clitoris, comprising: (a) an effective amount of a prostaglandin; and (b) a pharmaceutically acceptable carrier; wherein said carrier provides release of the prostaglandin from the composition within about 1 minute to about 60 minutes following administration.  
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein said prostaglandin is selected from the group consisting of prostaglandin E-1; prostaglandin E-2; prostaglandin F-2α; prostaglandin A-1; prostaglandin B-1; prostaglandin D-2; prostaglandin E-M; prostaglandin F-M; prostaglandin H-2; prostaglandin 1-2; 19-hydroxy-prostaglandin A-1; 19-hydroxy-prostaglandin B-1; prostaglandin A-2; prostaglandin B-2; 19-hydroxy-prostaglandin A-2; 19-hydroxy-prostaglandin B-2; prostaglandin B-3; prostaglandin F-1α; 15-methyl-prostaglandin F-2α; 16,16-dimethyl-Δ 2 -prostaglandin E-1 methyl ester; 15-deoxy-16-hydroxy-16-methyl-prostaglandin E-1 methyl ester; 16,16-dimethyl-prostaglandin E-2; 11-deoxy-15-methyl-prostaglandin E-1; 16-methyl-18,18,19,19-tetrahydrocarbacyclin; (16RS)-15-deoxy-16-hydroxy-1-6-methyl-prostaglandin E-1 methyl ester; (+)-4,5-didehydro-16-phenoxy-α-tetranor-prostaglandin E-2 methyl ester; 11-deoxy-11a, 16,16-trimethyl-prostaglandin E-2; (+)-11a, 16a,b-dihydroxy-1,9-dioxo-1-(hydroxymethyl)-16-methyl-trans-prostene; 9-chloro-16,16-dimethyl-prostaglandin E-2; and arboprostil.  
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein said prostaglandin is selected from the group consisting of prostaglandin E-1, prostaglandin E-2, prostaglandin F-2α, prostaglandin D-2, prostaglandin F-1α, 15-methyl-prostaglandin F-2α, prostaglandin E-3, prostaglandin D-1, and misoprostol.  
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein said prostaglandin is present in an amount of 0.1 nanograms to 2,000 μg/ml.  
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein said prostaglandin is PGE-1.  
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein said prostaglandin is PGE-2.  
     
     
         7 . The pharmaceutical composition of  claim 1 , which further comprises at least one coagent selected from the group consisting of agents which inhibit 15-hydroxyprostaglandindehydrogenase, ACE inhibitors, nitro vasodilators, alpha blockers, yohimbine, labetalol, carvedilol, bucindolol, phosphodiesterase inhibitors, muscarinic agents, dopaminergic agonists, ergot alkaloids, opiate antagonists, and polypeptide neurotransmitters.  
     
     
         8 . The pharmaceutical composition of  claim 7 , wherein the at least one coagent is an agent which inhibits 15-hydroxyprostaglandindehydrogenase.  
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the prostaglandin is a unit dose.  
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the unit dose is in the range of about 20 nanograms to about 2000 μg.  
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein the unit dose is in the range of about 200 nanograms to about 500 μg.  
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the carrier provides release of the prostaglandin from the composition within about 5 minutes to about 30 minutes following administration.  
     
     
         13 . The pharmaceutical composition of  claim 1 , which is in the form of a gel, solution, ointment, cream, liposomes or suppository.  
     
     
         14 . The pharmaceutical composition of  claim 1 , comprising a controlled-release dosage form.  
     
     
         15 . A packaged kit for use in enhancing female sexual desire and response, comprising: (a) means for containing a prostaglandin or a pharmaceutical composition comprising a prostaglandin; and (b) means for administering a prostaglandin or a pharmaceutical composition comprising a prostaglandin to the clitoris, wherein said means for containing contains a prostaglandin or a pharmaceutical composition comprising a prostaglandin; and (c) instructions for carrying out drug administration to enhance sexual desire and responsiveness, on an as-needed basis.  
     
     
         16 . The packaged kit of  claim 15 , wherein said prostaglandin is selected from the group consisting of prostaglandin E-1; prostaglandin E-2; prostaglandin F-2α; prostaglandin A-1; prostaglandin B-1; prostaglandin D-2; prostaglandin E-M; prostaglandin F-M; prostaglandin H-2; prostaglandin 1-2; 19-hydroxy-prostaglandin A-1; 19-hydroxy-prostaglandin B-1; prostaglandin A-2; prostaglandin B-2; 19-hydroxy-prostaglandin A-2; 19-hydroxy-prostaglandin B-2; prostaglandin B-3; prostaglandin F-1α; 15-methyl-prostaglandin F-2α; 16,16-dimethyl-α-Δ-prostaglandin E-1 methyl ester; 15-deoxy-16-hydroxy-16-methyl-prostaglandin E-1 methyl ester; 16,16-dimethyl-prostaglandin E-2; 11-deoxy-15-methyl-prostaglandin E-1; 16-methyl-18,18,19,19-tetrahydrocarbacyclin; (16RS)-15-deoxy-16-hydroxy-16-methyl-prostaglandin E-1 methyl ester; (+)-4,5-didehydro-16-phenoxy-α-tetranor-prostaglandin E-2 methyl ester; 11-deoxy-11a, 16,16-trimethyl-prostaglandin E-2; (+)-11a, 16a,b-dihydroxy-1,9-dioxo-1-(hydroxymethyl)-16-methyl-trans-prostene; 9-chloro-16,16-dimethyl-prostaglandin E-2; and arboprostil.  
     
     
         17 . The packaged kit of  claim 15 , wherein said prostaglandin is selected from the group consisting of prostaglandin E-1, prostaglandin E-2, prostaglandin F-2α, prostaglandin D-2, prostaglandin F-1α, and 15-methyl-prostaglandin F-2α.  
     
     
         18 . The packaged kit of  claim 15 , wherein said prostaglandin is PGE-1.  
     
     
         19 . The packaged kit of  claim 15 , wherein said prostaglandin is PGE-2.  
     
     
         20 . The packaged kit of  claim 15 , wherein said means for administering a prostaglandin or a pharmaceutical composition comprising a prostaglandin to the clitoris is capable of delivering said prostaglandin to said clitoris in an amount of 0.1 nanograms to 2,000 μg.  
     
     
         21 . The packaged kit of  claim 15 , wherein the prostaglandin is a unit dose.  
     
     
         22 . The packaged kit of  claim 21 , wherein the unit dose is in the range of about 20 nanograms to about 2000 μg.  
     
     
         23 . The packaged kit of  claim 22 , wherein the unit dose is in the range of about 200 nanograms to about 500 μg.  
     
     
         24 . The packaged kit of  claim 15 , wherein the pharmaceutical composition comprises a carrier that provides release of the prostaglandin from the composition within about 1 minute to about 60 minutes following application.  
     
     
         25 . The packaged kit of  claim 15 , which further comprises at least one coagent selected from the group consisting of agents which inhibit 15-hydroxyprostaglandindehydrogenase, ACE inhibitors, nitro vasodilators, alpha blockers, yohimbine, labetalol, carvedilol, bucindolol, phosphodiesterase inhibitors, muscarinic agents, dopaminergic agonists, ergot alkaloids, opiate antagonists, and polypeptide neurotransmitters.  
     
     
         26 . A pharmaceutical composition for topical administration to the clitoris, comprising: (a) a prostaglandin; (b) a 15-hydroxyprostaglandindehydrogenase inhibitor; and (c) a pharmaceutically acceptable carrier; wherein said carrier provides release of the prostaglandin from the composition within about 1 minute to about 60 minutes following administration.  
     
     
         27 . The pharmaceutical composition of  claim 26 , wherein said prostaglandin is selected from the group consisting of prostaglandin E-1; prostaglandin E-2; prostaglandin F-2α; prostaglandin A-1; prostaglandin B-1; prostaglandin D-2; prostaglandin E-M; prostaglandin F-M; prostaglandin H-2; prostaglandin I-2; 19-hydroxy-prostaglandin A-1; 19-hydroxy-prostaglandin B-1; prostaglandin A-2; prostaglandin B-2; 19-hydroxy-prostaglandin A-2; 19-hydroxy-prostaglandin B-2; prostaglandin B-3; prostaglandin F-1α; 15-methyl-prostaglandin F-2α; 16,16-dimethyl-Δ 2 -prostaglandin E-1 methyl ester; 15-deoxy-16-hydroxy-16-methyl-prostaglandin E-1 methyl ester; 16,16-dimethyl-prostaglandin E-2; 11-deoxy-15-methyl-prostaglandin E-1; 16-methyl-18,18,19,19-tetrahydrocarbacyclin; (16RS)-15-deoxy-16-hydroxy-1-6-methyl-prostaglandin E-1 methyl ester; (+)-4,5-didehydro-16-phenoxy-α-tetranor-prostaglandin E-2 methyl ester; 11-deoxy-11α, 16,16-trim-ethyl-prostaglandin E-2; (+)-11a, 16a,b-dihydroxy-1,9-dioxo-1-(hydroxymethyl)-16-methyl-trans-prostene; 9-chloro-16,16-dimethyl-prostaglandin E-2; and arboprostil.  
     
     
         28 . The pharmaceutical composition of  claim 26 , wherein said prostaglandin is selected from the group consisting of prostaglandin E-1, prostaglandin E-2, prostaglandin F-2α, prostaglandin D-2, prostaglandin F-1α, 15-methyl-prostaglandin F-2α, prostaglandin E-3, prostaglandin D-1, and misoprostol.  
     
     
         29 . The pharmaceutical composition of  claim 26 , wherein said prostaglandin is present in an amount of 0.1 nanograms to 2,000 μg/ml.  
     
     
         30 . The pharmaceutical composition of  claim 26 , wherein said prostaglandin is PGE-1.  
     
     
         31 . The pharmaceutical composition of  claim 26 , wherein said prostaglandin is PGE-2.  
     
     
         32 . The pharmaceutical composition of  claim 26 , which further comprises at least one coagent selected from the group consisting of agents which inhibit ACE inhibitors, nitro vasodilators, alpha blockers, yohimbine, labetalol, carvedilol, bucindolol, phosphodiesterase inhibitors, muscarinic agents, dopaminergic agonists, ergot alkaloids, opiate antagonists, and polypeptide neurotransmitters.  
     
     
         33 . The pharmaceutical composition of  claim 26 , wherein the prostaglandin is a unit dose.  
     
     
         34 . The pharmaceutical composition of  claim 33 , wherein the unit dose is in the range of about 20 nanograms to about 2000 μg.  
     
     
         35 . The pharmaceutical composition of  claim 34 , wherein the unit dose is in the range of about 200 nanograms to about 500 μg.  
     
     
         36 . The pharmaceutical composition of  claim 26 , wherein the carrier provides release of the prostaglandin from the composition within about 5 minutes to about 30 minutes following application to the clitoris.  
     
     
         37 . The pharmaceutical composition of  claim 26 , which is in the form of a gel, solution, ointment, cream, liposomes or suppository.