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Safety Study of XP12B in Women With Menorrhagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00113568
Recruitment Status : Completed
First Posted : June 9, 2005
Results First Posted : January 20, 2010
Last Update Posted : June 15, 2010
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Menorrhagia
Heavy Menstrual Bleeding
Intervention Drug: Tranexamic acid tablets (XP12B)
Enrollment 784
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Period Title: Overall Study
Started 784
Intent to Treat Population 723
Completed 239
Not Completed 545
Reason Not Completed
Adverse Event             97
Death             1
Lack of Efficacy             30
Lost to Follow-up             156
Protocol Violation             32
Withdrawal by Subject             117
Other             112
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Baseline Participants 723
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 723 participants
38  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 723 participants
Female
723
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Subjects With at Least One Adverse Event During the Study
Hide Description 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.
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 723
Measure Type: Number
Unit of Measure: participants
678
2.Primary Outcome
Title Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study
Hide Description 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.
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 723
Measure Type: Number
Unit of Measure: participants
306
3.Primary Outcome
Title Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study
Hide Description 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.
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 723
Measure Type: Number
Unit of Measure: participants
40
4.Primary Outcome
Title Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study
Hide Description 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.
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 723
Measure Type: Number
Unit of Measure: participants
13
5.Primary Outcome
Title Number of Subjects With at Least One Serious Adverse Event During the Study
Hide Description 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.
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 723
Measure Type: Number
Unit of Measure: participants
28
6.Primary Outcome
Title Number of Subjects With at Least One Life-Threatening Adverse Event During the Study
Hide Description A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 723
Measure Type: Number
Unit of Measure: participants
2
7.Primary Outcome
Title Number of Subjects With Adverse Events That Led to Discontinuation From the Study
Hide Description 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
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 784
Measure Type: Number
Unit of Measure: participants
97
8.Primary Outcome
Title Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study
Hide Description Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 723
Measure Type: Number
Unit of Measure: participants
0
9.Primary Outcome
Title Number of Subjects Who Died During the Study
Hide Description Number of subjects who died, for any reason, during the study
Time Frame Up to 27 menstrual cycles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description:
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
Overall Number of Participants Analyzed 784
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tranexamic Acid Tablets (XP12B)
Hide Arm/Group Description Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
All-Cause Mortality
Tranexamic Acid Tablets (XP12B)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tranexamic Acid Tablets (XP12B)
Affected / at Risk (%)
Total   28/723 (3.87%) 
Blood and lymphatic system disorders   
Anemia  1  1/723 (0.14%) 
Cardiac disorders   
Cardiac Arrest  1  1/723 (0.14%) 
Gastrointestinal disorders   
Colitis  1  1/723 (0.14%) 
Hiatus Hernia  1  1/723 (0.14%) 
Hepatobiliary disorders   
Cholecystitis  1  1/723 (0.14%) 
Infections and infestations   
Abdominal Wall Abscess  1  1/723 (0.14%) 
Appendicitis  1  1/723 (0.14%) 
Cellulitis  1  2/723 (0.28%) 
Glycopeptide antiobiotic resistant staphylococcal aureus infection  1  1/723 (0.14%) 
Malaria  1  1/723 (0.14%) 
Aseptic meningitis  1  1/723 (0.14%) 
Pneumococcal sepsis  1  1/723 (0.14%) 
Pneumonia  1  1/723 (0.14%) 
Wound Abscess  1  1/723 (0.14%) 
Injury, poisoning and procedural complications   
Animal Bite  1  1/723 (0.14%) 
Post procedural complication  1  2/723 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Astrocytoma  1  1/723 (0.14%) 
Renal cell carcinoma stage unspecified  1  1/723 (0.14%) 
Nervous system disorders   
Headache  1  1/723 (0.14%) 
Migraine  1  4/723 (0.55%) 
Neuritis  1  1/723 (0.14%) 
Partial seizures with secondary generalization  1  2/723 (0.28%) 
Syncope  1  1/723 (0.14%) 
Pregnancy, puerperium and perinatal conditions   
Ectopic Pregnancy  1  1/723 (0.14%) 
Psychiatric disorders   
Depression  1  1/723 (0.14%) 
Reproductive system and breast disorders   
Adenomyosis  1  1/723 (0.14%) 
Dysmenorrhea  1  1/723 (0.14%) 
Menorrhagia  1  4/723 (0.55%) 
Uterine Leiomyoma  1  3/723 (0.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tranexamic Acid Tablets (XP12B)
Affected / at Risk (%)
Total   678/723 (93.78%) 
Blood and lymphatic system disorders   
Anemia  1  37/723 (5.12%) 
Gastrointestinal disorders   
Abdominal Discomfort  1  87/723 (12.03%) 
Upper abdominal pain  1  65/723 (8.99%) 
Diarrhea  1  88/723 (12.17%) 
Dyspepsia  1  60/723 (8.30%) 
Nausea  1  104/723 (14.38%) 
Toothache  1  42/723 (5.81%) 
Vomiting  1  43/723 (5.95%) 
General disorders   
Fatigue  1  57/723 (7.88%) 
Immune system disorders   
Multiple allergies  1  39/723 (5.39%) 
Seasonal allergy  1  66/723 (9.13%) 
Infections and infestations   
Sinusitis  1  94/723 (13.00%) 
Upper respiratory tract infection  1  68/723 (9.41%) 
Urinary tract infection  1  45/723 (6.22%) 
Viral upper respiratory tract infection  1  137/723 (18.95%) 
Injury, poisoning and procedural complications   
Post procedural pain  1  51/723 (7.05%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  105/723 (14.52%) 
Back pain  1  227/723 (31.40%) 
Muscle cramp  1  41/723 (5.67%) 
Musculoskeletal pain  1  98/723 (13.55%) 
Myalgia  1  50/723 (6.92%) 
Neck pain  1  61/723 (8.44%) 
Pain in extremity  1  100/723 (13.83%) 
Nervous system disorders   
Dizziness  1  50/723 (6.92%) 
Headache  1  437/723 (60.44%) 
Migraine  1  78/723 (10.79%) 
Sinus headache  1  70/723 (9.68%) 
Psychiatric disorders   
Insomnia  1  74/723 (10.24%) 
Reproductive system and breast disorders   
Dysmenorrhea  1  78/723 (10.79%) 
Menstrual discomfort  1  360/723 (49.79%) 
Menorrhagia  1  40/723 (5.53%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  80/723 (11.07%) 
Nasal congestion  1  64/723 (8.85%) 
Sinus congestion  1  69/723 (9.54%) 
Throat irritation  1  100/723 (13.83%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
EMail: DK0-Disclosure@ferring.com
Layout table for additonal information
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00113568     History of Changes
Other Study ID Numbers: XP12B-MR-302
First Submitted: June 8, 2005
First Posted: June 9, 2005
Results First Submitted: December 11, 2009
Results First Posted: January 20, 2010
Last Update Posted: June 15, 2010