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US6306914B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Progestin therapy for maintaining amenorrhea

Assignee: COLUMBIA LOBORATORIES Inc
•
Filing: 1998-10-13
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Granted: 2001-10-23
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Expires: 2018-10-13
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Abstract

Abstract The present invention teaches that daily, cyclical vaginal delivery of progestin may be used to provide regular, predictable withdrawal bleeding during hormone replacement therapy. The present invention also teaches that constant administration of progestin in a water-insoluble, water-swellable cross-linked polycarboxylic acid polymer may be used to maintain amenorrhea. Either regimen is accompanied by a significant decrease in adverse side effects.

Inventors

  • 👤 Dominique de Ziegler
  • 👤 William J. Bologna
  • 👤 Howard L. Levine

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 13:54
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/56; A61K31/57; A61K9/00; A61K9/0012; A61K9/0034; A61P; A61P15/00; A61P15/12; A61P15/18; A61P5/00; A61P5/24; A61P5/34; A61K47/00; A61K47/30; A61K47/32; A61K9/70; A61K9/7023

Claims Analysis

Total Claims: 12
Claim 1
Independent Claim 64 words
A method of maintaining amenorrhea in a woman undergoing constant progestin administration comprising constant vaginal administration of progestin via a drug delivery system in an amount sufficient to cause endometrial atrophy within the first month of administration and to maintain endometrial atrophy without causing the side effects encountered with progestin administration: wherein the drug delivery system comprises a water-soluble, water-swellable cross-linked polycarboxylic acid polymer.
Claim 2
Independent Claim 64 words
A method of maintaining amenorrhea in a woman undergoing constant progestin administration comprising constant vaginal administration of progestin via a drug delivery system in an amount sufficient to cause endometrial atrophy within the first month of administration and to maintain endometrial atrophy without causing the side effects encountered with progestin administration: wherein the drug delivery system comprises a water-soluble, water-swellable cross-linked polycarboxylic acid polymer.
Claim 3
Dependent Claim 10 words
The method of claim 1 wherein the polymer is polycarbophil.
Claim 4
Dependent Claim 14 words
The method of claim 1 wherein the progestin is administered about twice per week.
Claim 5
Dependent Claim 14 words
The method of claim 2 wherein the progestin is administered about twice per week.
Claim 6
Dependent Claim 10 words
The method of claim 1 wherein the progestin is progesterone.
Claim 7
Dependent Claim 10 words
The method of claim 2 wherein the progestin is progesterone.
Claim 8
Dependent Claim 21 words
The method of claim 5 wherein the amount of progesterone delivered is about 45 mg to about 90 mg per dose.
Claim 9
Dependent Claim 21 words
The method of claim 6 wherein the amount of progesterone delivered is about 45 mg to about 90 mg per dose.
Claim 10
Dependent Claim 16 words
The method of claim 5 wherein the drug delivery system additionally comprises at least one adjuvant.
Claim 11
Dependent Claim 16 words
The method of claim 6 wherein the drug delivery system additionally comprises at least one adjuvant.
Claim 12
Dependent Claim 14 words
The method of claim 2 wherein the woman is also being treated with estrogen.

References Cited (Backward Citations)

US4615697A Cited
USD345211S Cited
WO1995007699A1 Cited
US5543150A Cited
USD375352S Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2004-10-22 2005-04-23 2005-10-23 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2008-10-22 2009-04-23 2009-10-23 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2012-10-22 2013-04-23 2013-10-23 $7700.00 Window Closed / Lapsed

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