Trial Outcomes & Findings for Safety Study of XP12B in Women With Menorrhagia (NCT NCT00113568)
NCT ID: NCT00113568
Last Updated: 2010-06-15
Results Overview
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.
COMPLETED
PHASE3
784 participants
Up to 27 menstrual cycles
2010-06-15
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
784
|
|
Overall Study
Intent to Treat Population
|
723
|
|
Overall Study
COMPLETED
|
239
|
|
Overall Study
NOT COMPLETED
|
545
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Adverse Event
|
97
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
30
|
|
Overall Study
Lost to Follow-up
|
156
|
|
Overall Study
Protocol Violation
|
32
|
|
Overall Study
Withdrawal by Subject
|
117
|
|
Overall Study
Other
|
112
|
Baseline Characteristics
Safety Study of XP12B in Women With Menorrhagia
Baseline characteristics by cohort
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Age Continuous
|
38 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
723 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesPopulation: intent to treat population
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.
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects With at Least One Adverse Event During the Study
|
678 participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesPopulation: intent to treat population
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.
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study
|
306 participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesPopulation: intent to treat population
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.
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study
|
40 participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesPopulation: intent to treat population
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.
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study
|
13 participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesPopulation: intent to treat population
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.
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects With at Least One Serious Adverse Event During the Study
|
28 participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesPopulation: intent to treat population
A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects With at Least One Life-Threatening Adverse Event During the Study
|
2 participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesThe 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
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=784 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects With Adverse Events That Led to Discontinuation From the Study
|
97 participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesPopulation: intent to treat population
Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 27 menstrual cyclesNumber of subjects who died, for any reason, during the study
Outcome measures
| Measure |
Tranexamic Acid Tablets (XP12B)
n=784 Participants
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Number of Subjects Who Died During the Study
|
1 participants
|
Adverse Events
Tranexamic Acid Tablets (XP12B)
Serious adverse events
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 participants at risk
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.14%
1/723
|
|
Cardiac disorders
Cardiac Arrest
|
0.14%
1/723
|
|
Gastrointestinal disorders
Colitis
|
0.14%
1/723
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.14%
1/723
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
1/723
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.14%
1/723
|
|
Infections and infestations
Appendicitis
|
0.14%
1/723
|
|
Infections and infestations
Cellulitis
|
0.28%
2/723
|
|
Infections and infestations
Glycopeptide antiobiotic resistant staphylococcal aureus infection
|
0.14%
1/723
|
|
Infections and infestations
Malaria
|
0.14%
1/723
|
|
Infections and infestations
Aseptic meningitis
|
0.14%
1/723
|
|
Infections and infestations
Pneumococcal sepsis
|
0.14%
1/723
|
|
Infections and infestations
Pneumonia
|
0.14%
1/723
|
|
Infections and infestations
Wound Abscess
|
0.14%
1/723
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.14%
1/723
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.28%
2/723
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.14%
1/723
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.14%
1/723
|
|
Nervous system disorders
Headache
|
0.14%
1/723
|
|
Nervous system disorders
Migraine
|
0.55%
4/723
|
|
Nervous system disorders
Neuritis
|
0.14%
1/723
|
|
Nervous system disorders
Partial seizures with secondary generalization
|
0.28%
2/723
|
|
Nervous system disorders
Syncope
|
0.14%
1/723
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.14%
1/723
|
|
Psychiatric disorders
Depression
|
0.14%
1/723
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.14%
1/723
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.14%
1/723
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.55%
4/723
|
|
Reproductive system and breast disorders
Uterine Leiomyoma
|
0.41%
3/723
|
Other adverse events
| Measure |
Tranexamic Acid Tablets (XP12B)
n=723 participants at risk
Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
37/723
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
12.0%
87/723
|
|
Gastrointestinal disorders
Upper abdominal pain
|
9.0%
65/723
|
|
Gastrointestinal disorders
Diarrhea
|
12.2%
88/723
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
60/723
|
|
Gastrointestinal disorders
Nausea
|
14.4%
104/723
|
|
Gastrointestinal disorders
Toothache
|
5.8%
42/723
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
43/723
|
|
General disorders
Fatigue
|
7.9%
57/723
|
|
Immune system disorders
Multiple allergies
|
5.4%
39/723
|
|
Immune system disorders
Seasonal allergy
|
9.1%
66/723
|
|
Infections and infestations
Sinusitis
|
13.0%
94/723
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
68/723
|
|
Infections and infestations
Urinary tract infection
|
6.2%
45/723
|
|
Infections and infestations
Viral upper respiratory tract infection
|
18.9%
137/723
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
7.1%
51/723
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.5%
105/723
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.4%
227/723
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
5.7%
41/723
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.6%
98/723
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
50/723
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.4%
61/723
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
100/723
|
|
Nervous system disorders
Dizziness
|
6.9%
50/723
|
|
Nervous system disorders
Headache
|
60.4%
437/723
|
|
Nervous system disorders
Migraine
|
10.8%
78/723
|
|
Nervous system disorders
Sinus headache
|
9.7%
70/723
|
|
Psychiatric disorders
Insomnia
|
10.2%
74/723
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
10.8%
78/723
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
49.8%
360/723
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
80/723
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.9%
64/723
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.5%
69/723
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
13.8%
100/723
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.5%
40/723
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER