Trial Outcomes & Findings for Efficacy and Safety of XP12B in Women With Menorrhagia (NCT NCT00401193)
NCT ID: NCT00401193
Last Updated: 2015-05-13
Results Overview
reduction of menstrual blood loss in mL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Baseline MBL over 3 menstrual cycles
Results posted on
2015-05-13
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
|
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
|
Placebo
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|---|
|
Overall Study
STARTED
|
118
|
117
|
69
|
|
Overall Study
Intent to Treat Population
|
115
|
115
|
67
|
|
Overall Study
Modified Intent to Treat Population
|
112
|
115
|
67
|
|
Overall Study
COMPLETED
|
103
|
106
|
63
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
6
|
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
|
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
|
Placebo
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
|
Overall Study
Other Event
|
3
|
2
|
2
|
Baseline Characteristics
Efficacy and Safety of XP12B in Women With Menorrhagia
Baseline characteristics by cohort
| 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
|
1950 mg/Day
n=115 Participants
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
|
Placebo
n=67 Participants
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 6 • n=5 Participants
|
40 years
STANDARD_DEVIATION 6 • n=7 Participants
|
39 years
STANDARD_DEVIATION 6 • n=5 Participants
|
39 years
STANDARD_DEVIATION 6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline MBL over 3 menstrual cyclesPopulation: modified intent to treat population
reduction of menstrual blood loss in mL
Outcome measures
| Measure |
3900 mg/Day
n=112 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
1950 mg/Day
n=115 Participants
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
|
Placebo
n=67 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)
|
65 mL
Standard Deviation 51
|
44 mL
Standard Deviation 57
|
7 mL
Standard Deviation 46
|
SECONDARY outcome
Timeframe: Baseline scores over 3 menstrual cyclesPopulation: modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)
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
Outcome measures
| Measure |
3900 mg/Day
n=112 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
1950 mg/Day
n=66 Participants
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
|
Placebo
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
|
1.0 units on a scale
Standard Deviation 1.1
|
0.4 units on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: Baseline scores over 3 menstrual cyclesPopulation: modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)
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
Outcome measures
| Measure |
3900 mg/Day
n=112 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
1950 mg/Day
n=66 Participants
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
|
Placebo
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|---|
|
Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding
|
0.9 units on a scale
Standard Deviation 1.0
|
0.3 units on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: Baseline over 3 mentrual 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=111 Participants
Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
|
1950 mg/Day
n=67 Participants
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
|
Placebo
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|---|
|
Responder Analysis - Reduction in Large Stains
|
64 percentage of participants
|
52 percentage of participants
|
—
|
Adverse Events
3900 mg/Day
Serious events: 1 serious events
Other events: 97 other events
Deaths: 0 deaths
1950 mg/Day
Serious events: 1 serious events
Other events: 104 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3900 mg/Day
n=115 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
|
1950 mg/Day
n=115 participants at risk
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
|
Placebo
n=67 participants at risk
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|---|
|
General disorders
Chest Pain
|
0.87%
1/115
|
0.00%
0/115
|
0.00%
0/67
|
|
Gastrointestinal disorders
Dyspepsia
|
0.87%
1/115
|
0.00%
0/115
|
0.00%
0/67
|
|
Gastrointestinal disorders
Gastritis
|
0.87%
1/115
|
0.00%
0/115
|
0.00%
0/67
|
|
Reproductive system and breast disorders
Ovarian Torsion
|
0.00%
0/115
|
0.87%
1/115
|
0.00%
0/67
|
Other adverse events
| Measure |
3900 mg/Day
n=115 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
|
1950 mg/Day
n=115 participants at risk
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
|
Placebo
n=67 participants at risk
Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
23/115
|
20.9%
24/115
|
22.4%
15/67
|
|
Blood and lymphatic system disorders
Anemia
|
0.87%
1/115
|
5.2%
6/115
|
1.5%
1/67
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
5/115
|
6.1%
7/115
|
1.5%
1/67
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
17.4%
20/115
|
17.4%
20/115
|
10.4%
7/67
|
|
General disorders
Fatigue
|
3.5%
4/115
|
11.3%
13/115
|
4.5%
3/67
|
|
Nervous system disorders
Headache
|
41.7%
48/115
|
47.0%
54/115
|
38.8%
26/67
|
|
Nervous system disorders
Migraine
|
6.1%
7/115
|
6.1%
7/115
|
6.0%
4/67
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps & Spasms
|
5.2%
6/115
|
2.6%
3/115
|
4.5%
3/67
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
11.3%
13/115
|
13.0%
15/115
|
3.0%
2/67
|
|
Immune system disorders
Nasal & Sinus Symptoms
|
13.9%
16/115
|
30.4%
35/115
|
10.4%
7/67
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER