Menorrhagia Instrument and Method for the Treatment of Menstrual Bleeding Disorders

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.

2 . The method of claim 1 , wherein step a) further comprises determining the perceived work limitation during a patient's most recent menstrual period, wherein the perceived work limitation is determined based upon the patient's response about how much their blood loss limited their work outside or inside the home, the patient's response being based on a five point scale selected from the group consisting of i) “not at all”, ii) “slightly”, iii) “moderately”, iv) “quite a bit”, and v) “extremely”.

3 . The method of claim 2 , wherein step a) further comprises determining the perceived limitation on the patient's physical activities during a patient's most recent menstrual period, wherein the perceived limitation is determined based upon the patient's response about how much their blood loss limited their physical activities, the patient's response being based on a five point scale selected from the group consisting i) “not at all”, ii) “slightly”, iii) “moderately”, iv) “quite a bit”, and v) “extremely”.

4 . The method of claim 3 , wherein step a) further comprises determining the perceived limitation on social and leisure activities during a patient's most recent menstrual period, wherein the perceived limitation is determined based upon the patient's response about how much their blood loss limited their social and leisure activities, the patient's response being based on a five point scale selected from the group consisting of i) “not at all”, ii) “slightly”, iii) “moderately”, iv) “quite a bit”, and v) “extremely”.

5 . The method of claim 4 , wherein step a) further comprises determining the specific activities that were limited by the patient's blood loss during a patient's most recent menstrual period, wherein the specific activities are selected from the group consisting of walking, standing, climbing stairs, squatting or bending down, childcare, shopping, home management, leisure, exercise, sports, gardening, traveling or vacation and any other physical, social or leisure activity.

6 . The method of claim 2 , further comprising classifying the patient as a responder to the administration of the tranexamic acid treatment regimen based upon the patient's response to an inquiry about the perceived work limitation, wherein the patient experiences an improvement in the perceived limitation of at least one unit.

7 . The method of claim 3 , further comprising classifying the patient as a responder to the administration of the tranexamic acid treatment regimen based upon the patient's response to an inquiry about the perceived limitation on the patient's physical activities, wherein the patient experiences an improvement in the perceived limitation of at least one unit.

8 . The method of claim 4 , further comprising classifying the patient as a responder to the administration of the tranexamic acid treatment regimen based upon the patient's response to an inquiry about the perceived limitation on the patient's social and leisure activities, wherein the patient experiences an improvement in the perceived limitation of at least one unit.

9 . The method of claim 6 , wherein the at least one unit improvement in perceived limitation is selected from the group consisting of i) “extremely” to “quite a bit”, ii) “quite a bit” to “moderately”, iii) “moderately” to “slightly”, and iv) “slightly” to “not at all”.

10 . The method of claim 7 , wherein the at least one unit improvement in perceived limitation is selected from the group consisting of i) “extremely” to “quite a bit”, ii) “quite a bit” to “moderately”, iii) “moderately” to “slightly”, and iv) “slightly” to “not at all”.

11 . The method of claim 8 , wherein the at least one unit improvement in perceived limitation is selected from the group consisting of i) “extremely” to “quite a bit”, ii) “quite a bit” to “moderately”, iii) “moderately” to “slightly”, and iv) “slightly” to “not at all”.

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.