Menorrhagia Instrument and Method for the Treatment of Menstrual Bleeding Disorders
First Claim
Patent Images
1. A method of using tranexamic acid in the treatment of heavy menstrual bleeding for a female patient in need thereof comprising:
- a) determining the perceived amount of blood loss during a patient'"'"'s most recent menstrual period, wherein the perceived amount of blood loss is determined based upon the patient'"'"'s response about their blood loss on a four point scale;
said scale comprising a response selected from the group consisting of i) “
light”
, ii) “
moderate”
, iii) “
heavy”
, and iv) “
very heavy”
;
b) identifying a patient in need of therapy as one with a perceived blood loss of greater than or equal to a response of “
heavy”
;
c) administering a therapeutically effective treatment regimen of a modified release tranexamic acid formulation for treating heavy menstrual bleeding, said treatment regimen to be administered beginning at the start of the patient'"'"'s next menstrual period for at least about 3 days;
d) determining a change in the perceived amount of blood loss after administration of the tranexamic acid treatment regimen, and determining whether that change was meaningful to the patient, wherein the change in the perceived amount of blood loss is determined based upon the patient'"'"'s response on a three point scale comprising a response selected from the group consisting of i) “
about the same”
, ii) “
better”
, and iii) “
worse”
, and the meaningfulness of the change to the patient is based upon the patient'"'"'s response about the change on a two point scale comprising a response selected from the group consisting of “
yes” and
“
no”
; and
e) classifying the patient as a responder when the patient'"'"'s response to the change in perceived amount of blood loss in step (d) is “
better”
, and the patient perceives the change to be meaningful.
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Abstract
Disclosed is a Menorrhagia Instrument and methods for the treatment of menstrual bleeding disorders.
122 Citations
12 Claims
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1. A method of using tranexamic acid in the treatment of heavy menstrual bleeding for a female patient in need thereof comprising:
-
a) determining the perceived amount of blood loss during a patient'"'"'s most recent menstrual period, wherein the perceived amount of blood loss is determined based upon the patient'"'"'s response about their blood loss on a four point scale;
said scale comprising a response selected from the group consisting of i) “
light”
, ii) “
moderate”
, iii) “
heavy”
, and iv) “
very heavy”
;b) identifying a patient in need of therapy as one with a perceived blood loss of greater than or equal to a response of “
heavy”
;c) administering a therapeutically effective treatment regimen of a modified release tranexamic acid formulation for treating heavy menstrual bleeding, said treatment regimen to be administered beginning at the start of the patient'"'"'s next menstrual period for at least about 3 days; d) determining a change in the perceived amount of blood loss after administration of the tranexamic acid treatment regimen, and determining whether that change was meaningful to the patient, wherein the change in the perceived amount of blood loss is determined based upon the patient'"'"'s response on a three point scale comprising a response selected from the group consisting of i) “
about the same”
, ii) “
better”
, and iii) “
worse”
, and the meaningfulness of the change to the patient is based upon the patient'"'"'s response about the change on a two point scale comprising a response selected from the group consisting of “
yes” and
“
no”
; ande) classifying the patient as a responder when the patient'"'"'s response to the change in perceived amount of blood loss in step (d) is “
better”
, and the patient perceives the change to be meaningful. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of diagnosing and treating heavy menstrual bleeding comprising assessing, and monitoring the symptoms of heavy menstrual bleeding comprising assessing the patient'"'"'s blood loss during their most recent menstrual period, assessing the symptomatic limitation on physical activities, assessing the limitation on social/leisure activities;
- identifying a patient in need of therapy as one with a perceived blood loss of greater to or equal to heavy or very heavy;
administering a treatment regimen of a tranexamic acid comprising at least 1.9 g/day for at least one day of the monthly menstrual period;
determining the change in perceived blood loss and symptoms;
determining the change in blood loss as, about the same, better, or worse, wherein the patient perceives the change as meaningful or not meaningful;
classifying the patient as a responder to the administration of tranexamic acid when the blood loss response is at least the same or better, and the patient perceives the change to be meaningful, and optionally the patient experiences at least one category change in one symptomatic measure selected from the group of social/leisure measures or physical measures.
- identifying a patient in need of therapy as one with a perceived blood loss of greater to or equal to heavy or very heavy;
Specification
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Current AssigneeFerring BV (Ferring Holding SA)
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Original AssigneeXanodyne Pharmaceuticals, Inc.
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InventorsHeasley, Ralph A., Patrick, Donald, Ruff, Brian J., Moore, Keith A.
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Application NumberUS12/770,185Publication NumberTime in Patent OfficeDaysField of SearchUS Class Current514/561CPC Class CodesA61K 31/196 the amino group being direc...A61P 15/02 for disorders of the vagina
