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The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid tablets | Drug | 3900 mg/Day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | reduction of menstrual blood loss in mL | Baseline MBL over 3 menstrual cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding | A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited | Baseline scores over 3 menstrual cycles |
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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 | 35209 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21777897 | Derived | Freeman EW, Lukes A, VanDrie D, Mabey RG, Gersten J, Adomako TL. A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding. Am J Obstet Gynecol. 2011 Oct;205(4):319.e1-7. doi: 10.1016/j.ajog.2011.05.015. Epub 2011 May 14. | |
| 20942615 | Derived | Lukes AS, Muse K, Richter HE, Moore KA, Patrick DL. Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding. Curr Med Res Opin. 2010 Nov;26(11):2673-8. doi: 10.1185/03007995.2010.526098. Epub 2010 Oct 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3900 mg/Day | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation |
| FG001 | 1950 mg/Day | One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tranexamic acid tablets | Drug | 1950 mg/Day |
|
|
| Placebo tablets | Drug |
|
| Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited | Baseline scores over 3 menstrual cycles |
| Responder Analysis - Reduction in Large Stains | Percentage of subjects who experienced a reduction from baseline in the frequency of large stains | Baseline over 3 mentrual cycles |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Investigative Site | Tucson | Arizona | 85710 | United States |
| Investigative Site | Tucson | Arizona | 85712 | United States |
| Investigative Site | Little Rock | Arkansas | 72205 | United States |
| Investigative Site | Searcy | Arkansas | 72143 | United States |
| Investigative Site | Los Alamitos | California | 90720 | United States |
| Investigative Site | Los Angeles | California | 90027 | United States |
| Investigative Site | San Diego | California | 92108 | United States |
| Investigative Site | Denver | Colorado | 80202 | United States |
| Investigative Site | Groton | Connecticut | 06340 | United States |
| Investigative Site | Gainesville | Florida | 32610 | United States |
| Investigative Site | Jacksonville | Florida | 32216 | United States |
| Investigative Site | Lighthouse PT | Florida | 33064 | United States |
| Investigative Site | Miami | Florida | 33186 | United States |
| Investigative Site | Miami Beach | Florida | 33141 | United States |
| Investigative Site | New Port Richey | Florida | 34652 | United States |
| Investigative Site | Sarasota | Florida | 34233 | United States |
| Investigative Site | Atlanta | Georgia | 30328 | United States |
| Investigative Site | Decatur | Georgia | 30033 | United States |
| Investigative Site | Boise | Idaho | 83712 | United States |
| Investigative Site | Idaho Falls | Idaho | 83404 | United States |
| Investigative Site | Bloomington | Indiana | 47403 | United States |
| Investigative Site | Newton | Kansas | 67114 | United States |
| Investigative Site | Overland Park | Kansas | 66215 | United States |
| Investigative Site | Marrero | Louisiana | 70072 | United States |
| Investigative Site | Baltimore | Maryland | 21230 | United States |
| Investigative Site | Ann Arbor | Michigan | 48106 | United States |
| Investigative Site | Bingham Farms | Michigan | 48025 | United States |
| Investigative Site | Grand Rapids | Michigan | 49506 | United States |
| Investigative Site | Paw Paw | Michigan | 49079 | United States |
| Investigative Site | Saint Clair Shores | Michigan | 48081 | United States |
| Investigative Site | Kansas City | Missouri | 64114 | United States |
| Investigative Site | Missoula | Montana | 59808 | United States |
| Investigative Site | McCook | Nebraska | 69001 | United States |
| Investigative Site | Las Vegas | Nevada | 89128 | United States |
| Investigative Site | Lawrenceville | New Jersey | 08648 | United States |
| Investigative Site | Moorestown | New Jersey | 08057 | United States |
| Investigative Site | New Brunswick | New Jersey | 08903 | United States |
| Investigative Site | Albuquerque | New Mexico | 87131 | United States |
| Investigative Site | New York | New York | 10017 | United States |
| Investigative Site | Rochester | New York | 14621 | United States |
| Investigative Site | Durham | North Carolina | 27713 | United States |
| Investigative Site | Raleigh | North Carolina | 27607 | United States |
| Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Investigative Site | Bismarck | North Dakota | 58501 | United States |
| Investigative Site | Cleveland | Ohio | 44121 | United States |
| Investigative Site | Cleveland | Ohio | 44122 | United States |
| Investigative Site | Gallipolis | Ohio | 45631 | United States |
| Investigative Site | Zanesville | Ohio | 43701 | United States |
| Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Investigative Site | Eugene | Oregon | 97401 | United States |
| Investigative Site | Portland | Oregon | 97205 | United States |
| Investigative Site | Levittown | Pennsylvania | 19056 | United States |
| Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| Investigative Site | Philadelphia | Pennsylvania | 19114 | United States |
| Investigative Site | Phoenixville | Pennsylvania | 19460 | United States |
| Investigative Site | Strafford | Pennsylvania | 19087 | United States |
| Investigative Site | Wexford | Pennsylvania | 15090 | United States |
| Investigative Site | Wynnewood | Pennsylvania | 19096 | United States |
| Investigative Site | Greenville | South Carolina | 29605 | United States |
| Investigative Site | Sioux Falls | South Dakota | 57104 | United States |
| Investigative Site | Bristol | Tennessee | 37620 | United States |
| Investigative Site | Clarksville | Tennessee | 37043 | United States |
| Investigative Site | Nashville | Tennessee | 37203 | United States |
| Investigative Site | Austin | Texas | 78737 | United States |
| Investigative Site | Bryan | Texas | 77802 | United States |
| Investigative Site | Fort Worth | Texas | 76132 | United States |
| Investigative Site | Houston | Texas | 77030 | United States |
| Investigative Site | Plano | Texas | 75093 | United States |
| Investigative Site | Temple | Texas | 46502 | United States |
| Investigative Site | The Woodlands | Texas | 77380 | United States |
| Investigative Site | Waco | Texas | 76712 | United States |
| Investigative Site | Webster | Texas | 77598 | United States |
| Investigative Site | Pleasant Grove | Utah | 84062 | United States |
| Investigative Site | Salt Lake City | Utah | 84124 | United States |
| Investigative Site | West Jordan | Utah | 84088 | United States |
| Investigative Site | West Valley City | Utah | 84120 | United States |
| Investigative Site | Burlington | Vermont | 05401 | United States |
| Investigative Site | Norfolk | Virginia | 23502 | United States |
| Investigative Site | Richmond | Virginia | 23225 | United States |
| Investigative Site | Renton | Washington | 98055 | United States |
| FG002 | Placebo | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| Intent to Treat Population |
|
| Modified Intent to Treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3900 mg/Day | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation |
| BG001 | 1950 mg/Day | One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation |
| BG002 | Placebo | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Intent to Treat Population | 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 | Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | reduction of menstrual blood loss in mL | modified intent to treat population | Posted | Nov 2009 | Least Squares Mean | Standard Deviation | mL | Baseline MBL over 3 menstrual cycles |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding | A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited | modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis) | Posted | Dec 2009 | Least Squares Mean | Standard Deviation | units on a scale | Baseline scores over 3 menstrual cycles |
|
| |||||||||||||||||||||||||||||||
| Secondary | Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited | modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis) | Posted | Dec 2009 | Least Squares Mean | Standard Deviation | units on a scale | Baseline scores over 3 menstrual cycles |
|
| |||||||||||||||||||||||||||||||
| Secondary | Responder Analysis - Reduction in Large Stains | Percentage of subjects who experienced a reduction from baseline in the frequency of large stains | modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis) | Posted | Dec 2009 | Number | percentage of participants | Baseline over 3 mentrual 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 | 3900 mg/Day | Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation | 1 | 115 | 97 | 115 | ||
| EG001 | 1950 mg/Day | One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation | 1 | 115 | 104 | 115 | ||
| EG002 | Placebo | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation | 0 | 67 | 56 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Ovarian Torsion | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | 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 |
| |
| Fatigue | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Muscle Cramps & Spasms | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Nasal & Sinus Symptoms | Immune system disorders | MedDRA 7.1 | Systematic Assessment |
|
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| 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 |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Male |
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