The present invention provides methods for the prevention or treatment of Erectile dysfunction (ED) by administering SLPIs to animals, such as male humans. These methods can be administer together with vitamin D and/or phosphodiesterase 5 inhibitors.
CLAIMS 1<. A pharmaceutical composition for use in a method of treating erectile dysfunction in a> male human subject in need thereof, the composition comprising as an active< ingredient a human secretory leukocyte protease inhibitor or a polynucleotide coding>for the same, wherein the pharmaceutical composition is administered, in a manner which can affect the<corpora cavernosa of the penis of the male human subject in need thereof.> 2. The pharmaceutical composition for use according to claim 1, wherein the method is< for treating erectile dysfunction wherein the damage results from increased> superoxide and/or downregulation of SLPI.< 3. The pharmaceutical composition for use according to any one of claims 1 or 2, wherein>the erectile dysfunction is vascular erectile dysfunction. 4<. The pharmaceutical composition for use according to any one of claims 1 to 3, wherein>the composition is administered together, subsequently or simultaneously, with vitamin D, or a salt thereof. 5<. The pharmaceutical composition for use according to any one of claims 1 to 4, wherein>the active agent is the recombinant human secretory leukocyte protease inhibitor. 6<. The pharmaceutical composition for use according to any one of claims 1 to 4, wherein> the active ingredient is:< a. the human secretory leukocyte protease inhibitor of any of SEQ ID NO 1 to 3 or>any other sequence comprising variations in the amino acid sequences of anyone of SEQ ID NO 1 to SEQ ID NO 3, provided that the variations in the amino acid sequence maintain at least 75%, more preferably at least 80%, 90%, 95%, and most preferably 99% or more sequence identity and the molecule retains bioactivity; and/or b<. a polynucleotide sequence that may be transduced and/or transcribed in the>human or animal body leading to the expression of any one of SEQ ID NO 1 to 3 or any other sequence comprising variations in the amino acid sequences of anyone of SEQ ID NO 1 to SEQ ID NO 3, provided that the variations in the amino acid sequence maintain at least 75%, more preferably at least 80%, 90%, 95%, and most preferably 99% or more sequence identity and the molecule retains bioactivity.<7. The pharmaceutical composition for use according to any one of claims 1 to 6, wherein>the composition is administered prior to, or simultaneously to the administration of a selective phosphodiesterase 5 inhibitor (PDE5i) to the subject in need thereof.<8. The pharmaceutical composition for use according to claim 7, wherein the PDE5i is>selected from the group consisting of avanafil, lodenafil, mirodenafil, sildenafil, t<adalafil, vardenafil, udenafil, zaprinast, icariin and synthetic derivatives thereof, and>benzamidenafil.