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The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XP12B (tranexamic acid tablets) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid tablets (XP12B) | Drug | Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Adverse Event During the Study | An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship. | Up to 27 menstrual cycles |
| Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies. | Up to 27 menstrual cycles |
| Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies. | Up to 27 menstrual cycles |
| Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug. | Up to 27 menstrual cycles |
| Number of Subjects With at Least One Serious Adverse Event During the Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Birmingham | Alabama | 35235 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21867401 | Derived | Muse K, Lukes AS, Gersten J, Waldbaum A, Mabey RG, Trott E. Long-term evaluation of safety and health-related quality of life in women with heavy menstrual bleeding treated with oral tranexamic acid. Womens Health (Lond). 2011 Nov;7(6):699-707. doi: 10.2217/whe.11.65. Epub 2011 Aug 25. | |
| 21043553 | Derived | Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid Tablets (XP12B) | Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment.
| Up to 27 menstrual cycles |
| Number of Subjects With at Least One Life-Threatening Adverse Event During the Study | A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred. | Up to 27 menstrual cycles |
| Number of Subjects With Adverse Events That Led to Discontinuation From the Study | The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator | Up to 27 menstrual cycles |
| Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study | Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction. | Up to 27 menstrual cycles |
| Number of Subjects Who Died During the Study | Number of subjects who died, for any reason, during the study | Up to 27 menstrual cycles |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Investigative Site | Montgomery | Alabama | 36106 | United States |
| Investigative Site | Phoenix | Arizona | 85032 | United States |
| Investigative Site | Phoenix | Arizona | 85035 | United States |
| Investigative Site | Jonesboro | Arkansas | 72401 | United States |
| Investigative Site | Little Rock | Arkansas | 72205 | United States |
| Investigative Site | San Diego | California | 92103 | United States |
| Investigative Site | San Diego | California | 92108 | United States |
| Investigative Site | Colorado Springs | Colorado | 80909 | United States |
| Investigative Site | Denver | Colorado | 80202 | United States |
| Investigative Site | Fort Myers | Florida | 33916 | United States |
| Investigative Site | Miami | Florida | 33186 | United States |
| Investigative Site | New Port Richey | Florida | 34652 | United States |
| Investigative Site | Ocala | Florida | 34471 | United States |
| Investigative Site | Pinellas Park | Florida | 33781 | United States |
| Investigative Site | Venice | Florida | 34292 | United States |
| Investigative Site | West Palm Beach | Florida | 33407 | United States |
| Investigative Site | West Palm Beach | Florida | 33409 | United States |
| Investigative Site | Alpharetta | Georgia | 30005 | United States |
| Investigative Site | Roswell | Georgia | 30075 | United States |
| Investigative Site | Savannah | Georgia | 31405 | United States |
| Investigative Site | Savannah | Georgia | 31406 | United States |
| Investigative Site | Boise | Idaho | 83702 | United States |
| Investigative Site | Champaign | Illinois | 61820 | United States |
| Investigative Site | Evansville | Indiana | 47713 | United States |
| Investigative Site | Indianapolis | Indiana | 46250 | United States |
| Investigative Site | South Bend | Indiana | 46601 | United States |
| Investigative Site | Overland Park | Kansas | 66210 | United States |
| Investigative Site | Lexington | Kentucky | 40536 | United States |
| Investigative Site | Louisville | Kentucky | 40291 | United States |
| Investigative Site | Shreveport | Louisiana | 71103 | United States |
| Investigative Site | Portage | Michigan | 49024 | United States |
| Investigative Site | Chaska | Minnesota | 55318 | United States |
| Investigative Site | St Louis | Missouri | 63110 | United States |
| Investigative Site | St Louis | Missouri | 63117 | United States |
| Investigative Site | St Louis | Missouri | 63141 | United States |
| Investigative Site | Billings | Montana | 59102 | United States |
| Investigative Site | Omaha | Nebraska | 68131 | United States |
| Investigative Site | Las Vegas | Nevada | 89030 | United States |
| Investigative Site | Las Vegas | Nevada | 89128 | United States |
| Investigative Site | Moorestown | New Jersey | 08057 | United States |
| Investigative Site | Albuquerque | New Mexico | 87102 | United States |
| Investigative Site | Johnson City | New York | 13790 | United States |
| Investigative Site | Charlotte | North Carolina | 28209 | United States |
| Investigative Site | Durham | North Carolina | 27710 | United States |
| Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Investigative Site | Cincinnati | Ohio | 45249 | United States |
| Investigative Site | Cincinnati | Ohio | 45267 | United States |
| Investigative Site | Toledo | Ohio | 43614 | United States |
| Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| Investigative Site | Wexford | Pennsylvania | 15090 | United States |
| Investigative Site | Columbia | South Carolina | 29201 | United States |
| Investigative Site | Nashville | Tennessee | 37203 | United States |
| Investigative Site | Nashville | Tennessee | 37208 | United States |
| Investigative Site | Houston | Texas | 77030 | United States |
| Investigative Site | Norfolk | Virginia | 23507 | United States |
| Investigative Site | Seattle | Washington | 98105 | United States |
| Investigative Site | Tacoma | Washington | 98405 | United States |
| Intent to Treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid Tablets (XP12B) | Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With at Least One Adverse Event During the Study | An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship. | intent to treat population | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
|
| |||||||||||||||||||||||||
| Primary | Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies. | intent to treat population | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies. | intent to treat population | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study | The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug. | intent to treat population | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects With at Least One Serious Adverse Event During the Study | A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment. | intent to treat population | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects With at Least One Life-Threatening Adverse Event During the Study | A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred. | intent to treat population | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects With Adverse Events That Led to Discontinuation From the Study | The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
| |||||||||||||||||||||||||||
| Primary | Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study | Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction. | intent to treat population | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects Who Died During the Study | Number of subjects who died, for any reason, during the study | Posted | Dec 2009 | Number | participants | Up to 27 menstrual cycles |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid Tablets (XP12B) | Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | 28 | 723 | 678 | 723 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Abdominal Wall Abscess | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Glycopeptide antiobiotic resistant staphylococcal aureus infection | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Aseptic meningitis | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Wound Abscess | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Animal Bite | Injury, poisoning and procedural complications | MedDRA (7.1) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (7.1) | Systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (7.1) | Systematic Assessment |
| |
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (7.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Partial seizures with secondary generalization | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (7.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Uterine Leiomyoma | Reproductive system and breast disorders | MedDRA (7.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Upper abdominal pain | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Post procedural pain | Injury, poisoning and procedural complications | MedDRA (7.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Menstrual discomfort | Reproductive system and breast disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (7.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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