VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS
Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).
1 . A method of treating vulvovaginal atrophy (VVA), comprising vaginally administering to a subject in need thereof estradiol at a dosage of 4 mcg and increasing the dosage of estradiol if the subject does not exhibit an improvement in a clinical response for VVA.
2 . The method of claim 1 , wherein the estradiol is administered once daily for two weeks, then twice weekly thereafter.
3 . The method of claim 1 , wherein the estradiol is solubilized.
4 . The method of claim 1 , wherein a dosage form comprising the estradiol is manually inserted about two inches into the vagina.
5 . The method of claim 4 , wherein the estradiol is formulated in a soft gelatin capsule.
6 . The method of claim 1 , comprising increasing the dosage of estradiol to 10 mcg if the subject does not exhibit an improvement in the clinical response.
7 . The method of claim 1 , comprising increasing the dosage of estradiol to 25 mcg if the subject does not exhibit an improvement in the clinical response.
8 . The method of claim 1 , comprising maintaining the dosage of estradiol if an improvement in a clinical response is achieved.
9 . The method of claim 1 , comprising decreasing the dosage of estradiol if an improvement in a clinical response is achieved.
10 . A method of treating vulvovaginal atrophy (VVA), comprising vaginally administering to a subject in need thereof estradiol once daily for two weeks, then twice weekly thereafter, wherein the estradiol is administered at a dosage of 4 mcg.
11 . The method of claim 10 , wherein the estradiol is solubilized.
12 . The method of claim 10 , wherein a dosage form comprising the estradiol is manually inserted about two inches into the vagina.
13 . The method of claim 12 , wherein the estradiol is formulated in a soft gelatin capsule.
14 . A method of treating moderate to severe dyspareunia, comprising vaginally administering to a subject in need thereof estradiol at a dosage of 4 mcg and increasing the dosage of estradiol if the subject does not exhibit an improvement in the moderate to severe dyspareunia.
15 . The method of claim 14 , wherein the estradiol is administered once daily for two weeks, then twice weekly thereafter.
16 . The method of claim 14 , wherein the estradiol is solubilized.
17 . The method of claim 14 , wherein the estradiol is formulated in a soft gelatin capsule.
18 . The method of claim 14 , comprising increasing the dosage of estradiol to 10 mcg if the subject does not exhibit an improvement in the moderate to severe dyspareunia.
19 . The method of claim 14 , comprising increasing the dosage of estradiol to 25 mcg if the subject does not exhibit an improvement in the moderate to severe dyspareunia.