IP Library Granted Patent US 10,500,166
Granted Patent B2
US 10,500,166 · App. 13/848,325 · Granted Dec 10, 2019

Methods for the treatment of erectile dysfunction using fispemifene

Inventors: Robert L. Zerbe (Ann Arbor, MI); Alexander Bridges (Saline, MI); Risto Lammintausta (Turku, FI); Rochelle Hanley (Ann Arbor, MI); Stuart Dombey (Ann Arbor, MI)
Assignee: QUATRX PHARMACEUTICALS
A61K31/085A61K31/4985A61K31/519
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Quick Facts
Patent No.
US 10,500,166
App. No.
13/848,325
Granted
Dec 10, 2019
Kind
B2
Abstract

A method of treatment of erectile dysfunction (ED) comprises the step of administering fispemifene to a subject in need thereof in an amount effective to raise the subject's testosterone level. Fispemifene may be used in combination with a PDE-5 inhibitor in individuals who have failed to respond sufficiently to conventional ED treatment. Methods are also disclosed of treating ED by administering clomifene, enclomifene, ospemifene, toremifene and mixtures thereof in combination with a PDE-5 inhibitor.

Claims (12)

1. A method of treating erectile dysfunction, comprising administering a therapeutically effective amount of fispemifene to a subject in need thereof, the subject further suffering from secondary hypogonadism and metabolic syndrome.

2. The method of claim 1 wherein the subject has low serum total testosterone, in a range of less than about 400 ng/dL.

3. The method of claim 1 wherein the subject is insufficiently responsive to treatment with a PDE-5 inhibitor alone.

4. The method according to claim 1 , wherein the therapeutically effective amount of fispemifene is about 10 mg to about 1000 mg.

5. The method of claim 1 , further comprising administration of a therapeutically effective amount of a PDE-5 inhibitor.

6. The method of claim 5 , wherein the PDE-5 inhibitor is sildenafil, vardenafil, or tadalafil.

7. The method of claim 5 , wherein the PDE-5 inhibitor is tadalafil.

8. The method of claim 1 , wherein the therapeutically effective amount of fispemifene is an amount sufficient to raise levels of testosterone, luteinizing hormone, and follicle-stimulating hormone.

9. The method of claim 1 , wherein the therapeutically effective amount of fispemifene is about 10 mg to about 1000 mg administered orally.

10. The method of claim 7 , wherein the therapeutically effective amount of tadalafil is in the range of 2.5 mg to 20 mg administered orally.

11. The method of claim 3 , further comprising administration of a therapeutically effective amount of a PDE-5 inhibitor.

12. The method of claim 1 , wherein the erectile dysfunction is treated without harmful effects on fertility.