A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding

Inclusion Criteria:

• The study enrolled subjects who had completed the double-blind therapy in either theXP12B-MR-301 or XP12B-MR-303 study, including scheduled evaluations, with no majorprotocol violations and no study events that, in the opinion of the investigator,would preclude the subject's entry into the open-label safety study.

• A negative urine pregnancy test was required immediately before entry into this study.

• Women must have been surgically sterile or, if of childbearing potential, must havebeen in a monogamous relationship with a sterile partner or a partner of the same sex.

• Women must have used an acceptable barrier contraception method with spermicide forthe duration of the study or must have been using a copper intrauterine device (IUD).

• In the opinion of the investigator, the subject must be able to understand this study,cooperate with all study procedures, be able to return to the study site for visitswithin the required visit windows and be deemed likely to complete the study.

• Subject will provide voluntary, written consent to participate in the study by signingand dating an institutional review board (IRB)-approved informed consent before anyprocedures are performed or study drug is dispensed.

Exclusion Criteria:

• History or presence of clinically significant hepatic or renal disease or othermedical disease that might confound the study or be detrimental to the subject (e.g.,clinically significant cardiac arrhythmia, uncontrolled diabetes or uncontrolledhypertension) as determined by the investigator.

• Normal gynecological examination and breast examination.

• Clinically significant abnormalities on screening physical examination that mightconfound the study or be detrimental to the subject as assessed by the investigator.Abnormal clinically significant electrocardiograms (ECG) as determined by thecentralized cardiologist, or laboratory tests suggestive of a potentialpituitary-prolactin stimulating tumor (prolactin >=30 µg/L), thrombocytopenia (platelet count <100,000/mm3), uncontrolled hypothyroidism (TSH >=10 mU/L) or severeanemia (hemoglobin <8 g/dL]).

• Anovulatory dysfunctional uterine bleeding, metrorrhagia (irregular or frequentnoncyclic flow), menometrorrhagia (irregular or frequent excessive noncyclic flow) orpolymenorrhea (frequent flow, cycles of less than 21 days).

• History or presence of endometrial polyps, endometrial hyperplasia, endometrialcarcinoma or cervical carcinoma (includes cervical carcinoma in situ).

• History of bilateral oophorectomy or hysterectomy.

• Women who are pregnant, breastfeeding, planning to become pregnant during the study orbecome pregnant during the study.

• History or active presence of myocardial infarction or ischemic disease. History oractive presence of cerebrovascular accident, stroke, or transient ischemic attack.

• History or presence of thrombosis, thromboembolic disease or coagulopathy including,but not limited to, pulmonary embolism, deep venous thrombosis, phlebitis and anyintravascular clotting disorder.

• History or known presence of acquired or inherited thrombophilia, including, but notlimited to, antithrombin deficiency, Protein C and/or S deficiency, antiphospholipiddeficiency, Factor V Leiden mutation and prothrombin mutation. Thalassemia or sicklecell disease (sickle cell trait individuals are not excluded).

• History or presence of subarachnoid hemorrhage.

• Use or anticipated use of medications taken to relieve β-Hydroxy β-methylbutyric acid (HMB) including the use of vaginal [rings, creams, gels] and transdermal hormoneproducts; use of oral estrogen-, progestin- or SERM-containing drug products, orintrauterine progestins containing drug products. Use or anticipated use of Lupron (1or 3 month) depot injection or estrogen pellet or long-acting progestin injectables.

• Use or anticipated use of meclofenamate sodium, mefenamic acid, danazol, ordesmopressin acetate or herbal remedies. Herbal remedies include, but are not limitedto, Capsella bursa pastoris (i.e. Sheperd's Purse), Agnus castus (i.e. Chasteberry,Vitex), Cimicifuga racemosa (i.e. Black Cohosh), Symphytum officionale (i.e. Comfrey),and/or Angelica sinensis (i.e. Dong Quai).

• Use of or anticipated use of the following drugs: oral, transdermal, injectable andvaginal ring (NuvaRing®) hormonal contraceptives; anticoagulants (warfarin [Coumadin®], heparin, low-molecular-weight heparin (LMWH), etc.), aminocaproic acid (Amicar®) or Plaquenil®.

• Current use of an intrauterine device (IUD) other than copper IUDs.

• History or presence of hypersensitivity or idiosyncratic reaction to antifibrinolytics (tranexamic acid or aminocaproic acid).

• Use of any investigational drug except XP12B-MR during the current study.

• Presence of untreated malabsorption disorder or malnutrition including, but notlimited to, chronic diarrhea, celiac disease, short bowl syndrome, Whipple's diseaseor history of gastric bypass procedure.

• Presence of defective color vision as determined by the optometrist orophthalmologist. Inability of the subject to correctly identify symbols on plate 7 ofthe HRR eye test is not considered defective color vision provided the subjectcorrectly identifies the symbols on plates 11-20.

• History or presence of glaucoma, ocular hypertension, macular degeneration orretinopathies.

• History or presence of alcoholism or drug abuse within the past year.

• Malignancy, or treatment for malignancy, within the previous 2 years, with theexception of basal cell carcinomas of the skin or squamous cell carcinoma of the skin.

• Does not read or understand English.