US5543150A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method of progesterone delivery and affect thereof
Assignee: Actavis Laboratories UT Inc
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Filing: 1993-09-15
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Granted: 1996-08-06
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Expires: 2013-09-15
Abstract
Abstract The present invention teaches that relatively low levels of serum progesterone, 1 to 6 ng/ml, may be used to prevent endometrial cancer. The vaginal delivery of progesterone using a cross-linked polycarboxylic polymer produces this low serum progesterone level while also providing the full secretory transformation of the endometrium, indicating the efficacy of the progesterone. Such low levels of serum progesterone will decrease the risk of breast cancer experienced by women undergoing hormone replacement therapy ("HRT") and minimize the potential of other undesirable progesterone associated side effects.
Inventors
- 👤 William J. Bologna
- 👤 Howard L. Levine
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 15:43
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0034; A61K31/00; A61K31/56; A61K31/57; A61K47/00; A61K47/30; A61K47/32; A61P; A61P15/00; A61P5/00; A61P5/24
Claims Analysis
Total Claims: 28
Claim 1
Independent Claim
49 words
A method of delivering progesterone to women comprising delivery of progesterone via a drug delivery system inserted into the vagina in an amount sufficient to cause secretory transformation of the endometrium while maintaining serum levels of progesterone below 6.0 ng/ml for a continuous period of at least forty-eight hours.
Claim 2
Independent Claim
49 words
A method of delivering progesterone to women comprising delivery of progesterone via a drug delivery system inserted into the vagina in an amount sufficient to cause secretory transformation of the endometrium while maintaining serum levels of progesterone below 6.0 ng/ml for a continuous period of at least forty-eight hours.
Claim 3
Dependent Claim
16 words
A method according to claim 1 wherein 10-200 milligrams of progesterone are inserted into the vagina.
Claim 4
Dependent Claim
17 words
A method according to claim 1 wherein the serum level is 1 to 4 ng/ml of progesterone.
Claim 5
Dependent Claim
14 words
A method according to claim 1 wherein adjuvants are also inserted into the vagina.
Claim 6
Dependent Claim
14 words
A method according to claim 1 wherein the vagina has been primed with estradiol.
Claim 7
Independent Claim
21 words
A method according to any one of claims 1-5 wherein the drug delivery system comprises a cross-linked polycarboxylic polymer and progesterone.
Claim 8
Dependent Claim
11 words
A method according to claim 6 wherein the polymer is polycarbophil.
Claim 9
Independent Claim
37 words
A method of targeting the delivery of progesterone to the endometrium comprising inserting into the vagina a drug delivery system comprising a cross-linked carboxylic polymer and progesterone wherein 10-200 milligrams of progesterone are inserted into the vagina.
Claim 10
Independent Claim
37 words
A method of targeting the delivery of progesterone to the endometrium comprising inserting into the vagina a drug delivery system comprising a cross-linked carboxylic polymer and progesterone wherein 10-200 milligrams of progesterone are inserted into the vagina.
Claim 11
Dependent Claim
20 words
A method according to claim 8 wherein the resulting serum level of progesterone is 1 to 4 ng/ml of progesterone.
Claim 12
Dependent Claim
11 words
A method according to claim 8 wherein the polymer is polycarbophil.
Claim 13
Independent Claim
38 words
A method of targeting the delivery of progesterone to the endometrium comprising inserting into the vagina a drug delivery system comprising a cross-linked carboxylic polymer and progesterone wherein the drug delivery system additionally comprises at least one adjuvant.
Claim 14
Independent Claim
38 words
A method of targeting the delivery of progesterone to the endometrium comprising inserting into the vagina a drug delivery system comprising a cross-linked carboxylic polymer and progesterone wherein the drug delivery system additionally comprises at least one adjuvant.
Claim 15
Independent Claim
24 words
A method of causing secretory transformation in the endometrium while maintaining serum levels of progesterone between about 1 to less than about 5 ng/ml.
Claim 16
Independent Claim
24 words
A method of causing secretory transformation in the endometrium while maintaining serum levels of progesterone between about 1 to less than about 5 ng/ml.
Claim 17
Independent Claim
43 words
A method of causing secretory transformation in the endometrium while maintaining serum levels of progesterone between about 1 to 6 ng/ml, wherein the progesterone level is achieved by inserting into the vagina a drug delivery system comprising a cross-linked polycarboxylic polymer and progesterone.
Claim 18
Independent Claim
43 words
A method of causing secretory transformation in the endometrium while maintaining serum levels of progesterone between about 1 to 6 ng/ml, wherein the progesterone level is achieved by inserting into the vagina a drug delivery system comprising a cross-linked polycarboxylic polymer and progesterone.
Claim 19
Dependent Claim
16 words
A method according to claim 13 wherein 10-200 milligrams of progesterone are inserted into the vagina.
Claim 20
Dependent Claim
17 words
A method according to claim 13 wherein the serum level is 1 to 4 ng/ml of progesterone.
Claim 21
Dependent Claim
11 words
A method according to claim 13 wherein the polymer is polycarbophil.
Claim 22
Dependent Claim
17 words
A method according to claim 13 wherein the drug delivery system additionally comprises at least one adjuvant.
Claim 23
Dependent Claim
14 words
A method according to claim 13 wherein the vagina has been primed with estradiol.
Claim 24
Dependent Claim
24 words
A method according to claim 13 wherein the polymer is cross-linked with 0.1 to 6.0 weight percent of the polymer of a cross-linking agent.
Claim 25
Dependent Claim
18 words
A method according to claim 12 wherein the progesterone level is maintained between about 1 to 4 ng/ml.
Claim 26
Dependent Claim
18 words
A method according to claim 20 wherein the progesterone level is maintained between about 1 to 2 ng/ml.
Claim 27
Independent Claim
26 words
A method according to any one of claims 12, 20 and 21 wherein the progesterone is delivered via a drug delivery device inserted into the vagina.
Claim 28
Dependent Claim
25 words
A method according to claim 6 wherein the polymer is cross-linked with about 0.1 to 6.0 weight percent of the polymer of a cross-linking agent.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-08-06 | 2000-02-05 | 2000-08-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-08-06 | 2004-02-05 | 2004-08-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-08-06 | 2008-02-05 | 2008-08-06 | $7700.00 | Window Closed / Lapsed |