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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 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid tablets | Drug | 3900 mg/Day |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | reduction of menstrual blood loss in mL | Baseline MBL over 6 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 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 | Change from Baseline scores over 6 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 | Tucson | Arizona | 85712 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 20859150 | Derived | Lukes AS, Moore KA, Muse KN, Gersten JK, Hecht BR, Edlund M, Richter HE, Eder SE, Attia GR, Patrick DL, Rubin A, Shangold GA. Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):865-875. doi: 10.1097/AOG.0b013e3181f20177. |
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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 | Placebo | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo tablets | Drug |
|
|
| Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | A positive unit change 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 | Change from Baseline scores over 6 menstrual cycles |
| Responder Analysis - Reduction in Large Stains | Percentage of subjects who experienced a reduction from baseline in the frequency of large stains | Reduction from Baseline over 6 menstrual cycles |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Investigative Site | Little Rock | Arkansas | 72205 | United States |
| Investigative Site | Carmichael | California | 95608 | United States |
| Investigative Site | San Diego | California | 92123 | United States |
| Investigative Site | Upland | California | 91786 | United States |
| Investigative Site | Denver | Colorado | 80206 | United States |
| Investigative Site | Lakewood | Colorado | 80228 | United States |
| Investigative Site | Groton | Connecticut | 06340 | United States |
| Investigative Site | West Hartford | Connecticut | 06117 | United States |
| Investigative Site | Inverness | Florida | 34452 | United States |
| Investigative Site | Miami | Florida | 33133 | United States |
| Investigative Site | Miami | Florida | 33136 | United States |
| Investigative Site | Atlanta | Georgia | 30328 | United States |
| Investigative Site | Atlanta | Georgia | 30342 | United States |
| Investigative Site | Decatur | Georgia | 30033 | United States |
| Investigative Site | Savannah | Georgia | 31406 | United States |
| Investigative Site | Idaho Falls | Idaho | 83404 | United States |
| Investigative Site | Amite | Louisiana | 70422 | United States |
| Investigative Site | Baton Rouge | Louisiana | 70808 | United States |
| Investigative Site | Marrero | Louisiana | 70072 | United States |
| Investigative Site | Shreveport | Louisiana | 71115 | United States |
| Investigative Site | Paw Paw | Michigan | 49079 | United States |
| Investigative Site | Scottsbluff | Nebraska | 69361 | United States |
| Investigative Site | Lawrenceville | New Jersey | 08648 | United States |
| Investigative Site | Canfield | Ohio | 44406 | United States |
| Investigative Site | Centerville | Ohio | 45459 | United States |
| Investigative Site | Cleveland | Ohio | 44122 | United States |
| Investigative Site | Zanesville | Ohio | 43701 | United States |
| Investigative Site | Norman | Oklahoma | 73071 | United States |
| Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Investigative Site | Eugene | Oregon | 97401 | United States |
| Investigative Site | Medford | Oregon | 97504 | United States |
| Investigative Site | Portland | Oregon | 97210 | United States |
| Investigative Site | Salem | Oregon | 97301 | United States |
| Investigative Site | Abington | Pennsylvania | 19001 | United States |
| Investigative Site | Jenkintown | Pennsylvania | 19046 | United States |
| Investigative Site | Reading | Pennsylvania | 19606 | United States |
| Investigative Site | Charleston | South Carolina | 29401 | United States |
| Investigative Site | Columbia | South Carolina | 29201 | United States |
| Investigative Site | Greenville | South Carolina | 29615 | United States |
| Investigative Site | Greer | South Carolina | 29651 | United States |
| Investigative Site | Chattanooga | Tennessee | 37403 | United States |
| Investigative Site | Knoxville | Tennessee | 37920 | United States |
| Investigative Site | Memphis | Tennessee | 38119 | United States |
| Investigative Site | Dallas | Texas | 75235 | United States |
| Investigative Site | Houston | Texas | 77030 | United States |
| Investigative Site | Sandy City | Utah | 84070 | United States |
| Investigative Site | Spokane | Washington | 99207 | United States |
| Investigative Site | Charleston | West Virginia | 25301 | United States |
| Investigative Site | Huntington | West Virginia | 25701 | United States |
| Investigative Site | Menomonee Falls | Wisconsin | 53051 | United States |
| Intent to Treat Population |
|
| Modified Intent to Treat Population |
|
| COMPLETED |
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| 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 | Placebo | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation |
| BG002 | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding | A positive unit change 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 | Change from Baseline scores over 6 menstrual cycles |
|
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| |||||||||||||||||||||||||||
| Secondary | Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | A positive unit change 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 | Change from Baseline scores over 6 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 subjects | Reduction from Baseline over 6 menstrual cycles |
|
| |||||||||||||||||||||||||||||
| Primary | Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | reduction of menstrual blood loss in mL | modified intent to treat population | Posted | Least Squares Mean | Standard Deviation | mL | Baseline MBL over 6 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 | 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 | 2 | 117 | 111 | 117 | ||
| EG001 | Placebo | Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation | 3 | 72 | 66 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Bronchitis | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
| |
| Decreased Blood Sugar | Investigations | MedDRA (7.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Post-Traumatic Stress Disorder | Psychiatric disorders | MedDRA (7.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue 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 | Respiratory, thoracic and mediastinal 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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