Natural combination hormone replacement formulations and therapies

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

What is claimed is: 
     
         1 . A method of treating menopause symptoms in a woman with a uterus comprising:
 administering an effective amount of a pharmaceutical composition, the pharmaceutical composition comprising solubilized estradiol, suspended progesterone, and a solubilizing agent;   wherein each of the estradiol and the suspended progesterone are present in the solubilizing agent, the estradiol and the suspended progesterone are uniformly dispersed and at least about 90% of the estradiol is solubilized in the solubilizing agent; and   wherein the solubilizing agent comprises predominately a saturated C6-C12 oil.   
     
     
         2 . The method of  claim 1 , further comprising partially solubilized progesterone, wherein the partially solubilized progesterone is solubilized in the solubilizing agent. 
     
     
         3 . The method of  claim 1 , wherein the composition is formulated in a gelatin capsule. 
     
     
         4 . The method of  claim 1 , wherein the estradiol has a dosage strength of at least about 0.125 mg and wherein the progesterone has a dosage strength of at least about 25 mg. 
     
     
         5 . The method of  claim 1 , wherein the ratio of progesterone to estradiol is about 24:1, about 25:1, about 96:1, about 100:1, about 192:1, or about 200:1.