Trial Outcomes & Findings for Efficacy and Safety Study of XP12B in Women With Menorrhagia (NCT NCT00386308)
NCT ID: NCT00386308
Last Updated: 2011-05-04
Results Overview
reduction of menstrual blood loss in mL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
196 participants
Primary outcome timeframe
Baseline MBL over 6 menstrual cycles
Results posted on
2011-05-04
Participant Flow
Participant milestones
| Measure |
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
|
Placebo
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
73
|
|
Overall Study
Intent to Treat Population
|
117
|
72
|
|
Overall Study
Modified Intent to Treat Population
|
115
|
72
|
|
Overall Study
COMPLETED
|
94
|
54
|
|
Overall Study
NOT COMPLETED
|
29
|
19
|
Reasons for withdrawal
| Measure |
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
|
Placebo
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Protocol Violation
|
2
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
10
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Other Event
|
8
|
1
|
Baseline Characteristics
Efficacy and Safety Study of XP12B in Women With Menorrhagia
Baseline characteristics by cohort
| Measure |
3900 mg/Day
n=117 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
Placebo
n=72 Participants
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
39 years
STANDARD_DEVIATION 6 • n=5 Participants
|
39 years
STANDARD_DEVIATION 7 • n=7 Participants
|
39 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline MBL over 6 menstrual cyclesPopulation: modified intent to treat population
reduction of menstrual blood loss in mL
Outcome measures
| Measure |
3900 mg/Day
n=115 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
Placebo
n=72 Participants
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|
|
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
|
66 mL
Standard Deviation 64
|
18 mL
Standard Deviation 36
|
SECONDARY outcome
Timeframe: Change from Baseline scores over 6 menstrual cyclesPopulation: modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)
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
Outcome measures
| Measure |
3900 mg/Day
n=115 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
Placebo
n=72 Participants
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|
|
Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding
|
0.9 units on a scale
Standard Deviation 0.8
|
0.4 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Change from Baseline scores over 6 menstrual cyclesPopulation: modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)
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
Outcome measures
| Measure |
3900 mg/Day
n=115 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
Placebo
n=72 Participants
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|
|
Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
|
0.9 units on a scale
Standard Deviation 0.9
|
0.4 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Reduction from Baseline over 6 menstrual cyclesPopulation: modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)
Percentage of subjects who experienced a reduction from baseline in the frequency of large stains
Outcome measures
| Measure |
3900 mg/Day
n=115 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
Placebo
n=72 Participants
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|
|
Responder Analysis - Reduction in Large Stains
|
57 percentage of subjects
|
51 percentage of subjects
|
Adverse Events
3900 mg/Day
Serious events: 2 serious events
Other events: 111 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3900 mg/Day
n=117 participants at risk
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
Placebo
n=72 participants at risk
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|
|
Infections and infestations
Acute Bronchitis
|
0.00%
0/117
|
1.4%
1/72
|
|
Investigations
Decreased Blood Sugar
|
0.85%
1/117
|
0.00%
0/72
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/117
|
1.4%
1/72
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.00%
0/117
|
1.4%
1/72
|
|
Cardiac disorders
Tachycardia
|
0.85%
1/117
|
0.00%
0/72
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/117
|
1.4%
1/72
|
Other adverse events
| Measure |
3900 mg/Day
n=117 participants at risk
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
Placebo
n=72 participants at risk
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
19.7%
23/117
|
13.9%
10/72
|
|
Blood and lymphatic system disorders
Anemia
|
10.3%
12/117
|
5.6%
4/72
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
11/117
|
8.3%
6/72
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
23.9%
28/117
|
19.4%
14/72
|
|
General disorders
Fatigue
|
6.8%
8/117
|
4.2%
3/72
|
|
Nervous system disorders
Headache
|
59.0%
69/117
|
54.2%
39/72
|
|
Nervous system disorders
Migraine
|
6.0%
7/117
|
5.6%
4/72
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps & Spasms
|
7.7%
9/117
|
6.9%
5/72
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
11.1%
13/117
|
2.8%
2/72
|
|
Respiratory, thoracic and mediastinal disorders
Nasal & Sinus Symptoms
|
36.8%
43/117
|
23.6%
17/72
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER