NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES
Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.
1 . A method of treating a subject having vasomotor symptoms associated with estrogen deficiency, the method comprising:
administering to the subject a pharmaceutical composition comprising solubilized estradiol, suspended progesterone, and a solubilizing agent, wherein the solubilizing agent comprises a medium chain (C6-C12) oil;
wherein the frequency and/or severity of moderate to severe vasomotor symptoms associated with menopause is reduced.
2 . The method of claim 1 , wherein the frequency and/or severity of moderate to severe vasomotors symptoms associated with menopause is reduced compared to placebo or no treatment.
3 . The method of claim 1 , wherein both the frequency and the severity of moderate to severe vasomotors symptoms associated with menopause is reduced.
4 . The method of claim 1 , wherein the pharmaceutical composition comprises about 0.25 mg estradiol and about 50 mg progesterone.
5 . The method of claim 1 , wherein the pharmaceutical composition comprises about 0.50 mg estradiol and about 50 mg progesterone.
6 . The method of claim 1 , wherein the pharmaceutical composition comprises about 0.50 mg estradiol and about 100 mg progesterone.
7 . The method of claim 1 , wherein the pharmaceutical composition comprises about 1 mg estradiol and about 100 mg progesterone.
8 . The method of claim 1 , wherein the subject is female.
9 . The method of claim 1 , wherein the subject is a woman having a uterus.
10 . The method of claim 1 , wherein prior to treatment, the woman has a serum estradiol level of ≤50 pg/mL.
11 . The method of claim 1 , wherein prior to treatment, the woman has 7 moderate to severe hot flushes per day.
12 . The method of claim 1 , wherein prior to treatment, the woman has 50 moderate to severe hot flushes per week.
13 . The method of claim 1 , wherein the frequency and severity of moderate to severe vasomotor symptoms associated with menopause is reduced when compared with placebo treatment at 4 weeks.
14 . The method of claim 1 , wherein the frequency and severity of moderate to severe vasomotor symptoms associated with menopause is reduced when compared with placebo treatment at 12 weeks.
15 . The method of claim 1 , wherein the method results in a lower incidence of somnolence compared to the reference listed drug
16 . The method of claim 15 , wherein the reference listed drug is Prometrium.
17 . The method of claim 1 , wherein the vasomotor symptom are sleeted from the group consisting of hot flashes or flushes, night sweats, sweating, sleep disturbances, and combinations thereof.
18 . A method of treating a subject having vasomotor symptoms associated with estrogen deficiency, the method comprising:
administering to the subject a pharmaceutical composition comprising solubilized estradiol, suspended progesterone, and a solubilizing agent, wherein the solubilizing agent comprises a medium chain (C6-C12) oil;
wherein the frequency and severity of moderate to severe vasomotor symptoms associated with menopause is reduced when compared with placebo treatment; and
wherein the pharmaceutical composition is effective at achieving a ≤1% incidence rate of endometrial hyperplasia following 12 months of therapy.