Vaginal inserted estradiol pharmaceutical compositions and methods
AssigneeTherapeuticsMD, Inc.
InventorsSebastian Mirkin, Julia M. Amadio, Brian Bernick
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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).
Claims66
A method for treating the symptoms of vulvo-vaginal atrophy (VVA) comprising:
- administering a vaginal suppository comprising 4 μg to 25 μg of estradiol to a subject having VVA,
- wherein the treatment is effective within two weeks of the first administration.
A method for treating female sexual dysfunction, the method comprising administering to a female subject in need thereof, a vaginal suppository comprising:
- (a) a liquid composition comprising:
- a therapeutically effective amount of estradiol;
- a caprylic/capric triglyceride;
- a non-ionic surfactant comprising PEG-6 palmitostearate and ethylene glycol palmitostearate;
- and (b) a soft gelatin capsule;
- wherein the vaginal suppository includes from about 1 microgram to about 25 micrograms of estradiol;
- wherein estradiol is the only active hormone in the vaginal suppository.
A method for treating vaginal dryness, the method comprising administering to a female subject in need thereof, a vaginal suppository comprising:
- (a) a liquid composition comprising:
- a therapeutically effective amount of estradiol;
- a caprylic/capric triglyceride;
- a non-ionic surfactant comprising PEG-6 palmitostearate and ethylene glycol palmitostearate;
- and (b) a soft gelatin capsule;
- wherein the vaginal suppository includes from about 1 microgram to about 25 micrograms of estradiol;
- wherein estradiol is the only active hormone in the vaginal suppository.
A method for treating dyspareunia, the method comprising administering to a female subject in need thereof, a vaginal suppository comprising:
- (a) a liquid composition comprising:
- a therapeutically effective amount of estradiol;
- a caprylic/capric triglyceride;
- a non-ionic surfactant comprising PEG-6 palmitostearate and ethylene glycol palmitostearate;
- and (b) a soft gelatin capsule;
- wherein the vaginal suppository includes from about 1 microgram to about 25 micrograms of estradiol;
- wherein estradiol is the only active hormone in the vaginal suppository.
A method for reestrogenizing the vagina, labia, or vulva, the method comprising administering to a female subject in need thereof, a vaginal suppository comprising:
- (a) a liquid composition comprising:
- a therapeutically effective amount of estradiol;
- a caprylic/capric triglyceride;
- a non-ionic surfactant comprising PEG-6 palmitostearate and ethylene glycol palmitostearate;
- and (b) a soft gelatin capsule;
- wherein the vaginal suppository includes from about 1 microgram to about 25 micrograms of estradiol;
- wherein estradiol is the only active hormone in the vaginal suppository.
Dependencies are inferred from the claim text.