Vaginal inserted estradiol pharmaceutical compositions and methods
DCFirst Claim
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1. A method of treating vulvovaginal atrophy (VVA), comprising vaginally administering to a subject in need thereof a liquid pharmaceutical composition comprising estradiol at a dosage of 4 mcg, wherein the composition has a viscosity in the range of about 50 cP to about 1000 cP at 25°
- C., and increasing the dosage of estradiol if the subject does not exhibit an improvement in a clinical response for VVA.
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Abstract
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).
1210 Citations
21 Claims
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1. A method of treating vulvovaginal atrophy (VVA), comprising vaginally administering to a subject in need thereof a liquid pharmaceutical composition comprising estradiol at a dosage of 4 mcg, wherein the composition has a viscosity in the range of about 50 cP to about 1000 cP at 25°
- C., and increasing the dosage of estradiol if the subject does not exhibit an improvement in a clinical response for VVA.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- 12. A method of treating vulvovaginal atrophy (VVA), comprising vaginally administering to a subject in need thereof a liquid pharmaceutical composition comprising estradiol once daily for two weeks, then twice weekly thereafter, wherein the composition comprises estradiol at a dosage of 4 mcg and wherein the composition has a viscosity in the range of about 50 cP to about 1000 cP at 25°
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16. A method of treating moderate to severe dyspareunia, comprising vaginally administering to a subject in need thereof a liquid pharmaceutical composition comprising estradiol at a dosage of 4 mcg, wherein the composition has a viscosity in the range of about 50 cP to about 1000 cP at 25°
- C., and increasing the dosage of estradiol if the subject does not exhibit an improvement in the moderate to severe dyspareunia.
- View Dependent Claims (17, 18, 19, 20, 21)
Specification