US5877216A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Treatment of female sexual dysfunction
Assignee: Vivus LLC
•
Filing: 1997-10-28
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Granted: 1999-03-02
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Expires: 2017-10-28
Abstract
Abstract Methods and formulations for treating female sexual dysfunction are provided. A pharmaceutical composition formulated so as to contain a selected vasodilating agent is administered to the vagina or vulvar area of the individual undergoing treatment. Suitable vasodilating agents include naturally occurring prostaglandins, synthetic prostaglandin derivatives, endothelial-derived relaxation factors, vasoactive intestinal polypeptide agonists, smooth muscle relaxants, leukotriene inhibitors, pharmaceutically acceptable salts, esters and inclusion complexes of any of the foregoing, and mixtures thereof. The novel formulations are also useful for preventing the occurrence of yeast infections, improving vaginal muscle tone and tissue health, enhancing vaginal lubrication, and minimizing excess collagen deposition. A clitoral drug delivery device is also provided.
Inventors
- 👤 Virgil A. Place
- 👤 Leland F. Wilson
- 👤 Paul C. Doherty, Jr.
- 👤 Mark S. Hanamoto
- 👤 Alfred P. Spivack
- 👤 Neil Gesundheit
- 👤 Sean R. Bennett
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 21:51
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0034; A61K31/00; A61K31/13; A61K31/15; A61K31/21; A61K31/28; A61K31/295; A61K31/33; A61K31/395; A61K31/435; A61K31/47; A61K31/48; A61K31/535; A61K31/5375; A61K31/5377; A61K31/557; A61K31/5575; A61K31/558; A61K31/5585; A61K31/56; A61K45/00; A61K45/06; B; B82; B82Y; B82Y5/00
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
59 words
A method for treating sexual dysfunction in a female individual, comprising administering to the vagina and/or vulvar area of the individual a pharmaceutical formulation comprising an effective amount of a vasodilating agent selected from the group consisting of naturally occurring prostaglandins, synthetic prostaglandin derivatives, pharmaceutically acceptable salts, esters and inclusion complexes thereof, and combinations of any of the foregoing.
Claim 2
Independent Claim
59 words
A method for treating sexual dysfunction in a female individual, comprising administering to the vagina and/or vulvar area of the individual a pharmaceutical formulation comprising an effective amount of a vasodilating agent selected from the group consisting of naturally occurring prostaglandins, synthetic prostaglandin derivatives, pharmaceutically acceptable salts, esters and inclusion complexes thereof, and combinations of any of the foregoing.
Claim 3
Dependent Claim
19 words
The method of claim 1, wherein the pharmaceutical formulation further includes a pharmaceutical vehicle suited to vaginal drug administration.
Claim 4
Dependent Claim
21 words
The method of claim 1, wherein the vasodilating agent is a naturally occurring prostaglandin or a hydrolyzable lower alkyl ester thereof.
Claim 5
Dependent Claim
63 words
The method of claim 3, wherein the naturally occurring prostaglandin is selected from the group consisting of PGE 0 , PGE 1 , PGA 1 , PGB 1 , PGF 1 α, 19-hydroxy-PGA 1 , 19-hydroxy-PGB 1 , PGE 2 , PGA 2 , PGB 2 , 19-hydroxy-PGA 2 , 19-hydroxy-PGB 2 , PGE 3 , PGF 3 α and PGI 2 .
Claim 6
Dependent Claim
14 words
The method of claim 4, wherein the naturally occurring prostaglandin is PGE 0 .
Claim 7
Dependent Claim
14 words
The method of claim 4, wherein the naturally occurring prostaglandin is PGE 1 .
Claim 8
Dependent Claim
14 words
The method of claim 4, wherein the naturally occurring prostaglandin is PGE 2 .
Claim 9
Dependent Claim
21 words
The method of claim 1, wherein the vasodilating agent is a synthetic prostaglandin derivative or a hydrolyzable lower alkyl ester thereof.
Claim 10
Dependent Claim
26 words
The method of claim 8, wherein the synthetic prostaglandin derivative is selected from the group consisting of carboprost tromethamine, dinoprost tromethamine, gemeprost, metenoprost, sulprostone and tiaprost.
Claim 11
Dependent Claim
13 words
The method of claim 1, wherein the pharmaceutical formulation further includes a steroid.
Claim 12
Dependent Claim
22 words
The method of claim 1, wherein the pharmaceutical formulation further includes a compound which is a steroid agonist, partial agonist or antagonist.
Claim 13
Dependent Claim
25 words
The method of claim 11, wherein the compound is selected from the group consisting of tamoxifen, cenchroman, clomiphene, droloxifene, raloxifene and pharmaceutically acceptable salts thereof.
Claim 14
Dependent Claim
34 words
The method of claim 1, wherein the pharmaceutical formulation additionally includes a detergent in an amount effective to increase solubility of the vasodilating agent in the vehicle and bioavailability of the agent following administration.
Claim 15
Dependent Claim
23 words
The method of claim 1, wherein the pharmaceutical formulation further includes an effective inhibiting amount of a compound selected to inhibit prostaglandin-degrading enzymes.
Claim 16
Dependent Claim
23 words
The method of claim 1, wherein the pharmaceutical formulation is contained within a delivery system selected to provide a predetermined agent release profile.
Claim 17
Dependent Claim
12 words
The method of claim 15, wherein the agent release profile is pulsatile.
Claim 18
Dependent Claim
12 words
The method of claim 15, wherein the agent release profile is continuous.
Claim 19
Dependent Claim
12 words
The method of claim 15, wherein the agent release profile is cyclical.
Claim 20
Dependent Claim
12 words
The method of claim 15, wherein the agent release profile is diurnal.
Claim 21
Dependent Claim
25 words
The method of claim 1, wherein the pharmaceutical formulation is in the form of an ointment, cream, gel, solid, solution, suspension, foam or liposomal composition.
Claim 22
Dependent Claim
24 words
The method of claim 1, wherein the pharmaceutical formulation is contained within a vaginal ring, tampon, suppository, sponge, pillow, puff, or osmotic pump system.
Claim 23
Dependent Claim
28 words
The method of claim 1, wherein the method further comprises co-administering testosterone to the vulvar area of the individual in combination with vaginal administration of the vasodilating agent.
Claim 24
Dependent Claim
12 words
The method of claim 1, wherein the pharmaceutical formulation is administered vaginally.
Claim 25
Dependent Claim
18 words
The method of claim 1, wherein the pharmaceutical formulation is administered to the vulvar area of the individual.
Claim 26
Dependent Claim
22 words
The method of claim 1, wherein the pharmaceutical formulation is administered to the vagina and to the vulvar area of the individual.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-03-01 | 2002-08-31 | 2003-03-02 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-03-01 | 2006-08-31 | 2007-03-02 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-03-01 | 2010-08-31 | 2011-03-02 | $7700.00 | Window Closed / Lapsed |