Trial Outcomes & Findings for Safety and Efficacy Study of MT-2990 in Women With Endometriosis (NCT NCT03840993)
NCT ID: NCT03840993
Last Updated: 2025-12-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2025-12-31
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo, over 16 weeks
|
MT-2990
MT-2990, over 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
37
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Placebo, over 16 weeks
|
MT-2990
MT-2990, over 16 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Neutrophil count decrease, COVID-19
|
3
|
2
|
Baseline Characteristics
Safety and Efficacy Study of MT-2990 in Women With Endometriosis
Baseline characteristics by cohort
| Measure |
Placebo
n=39 Participants
Placebo, over 16 weeks
|
MT-2990
n=37 Participants
MT-2990, over 16 weeks
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 8.3 • n=1000 Participants
|
32.7 years
STANDARD_DEVIATION 7.6 • n=1986 Participants
|
33.8 years
STANDARD_DEVIATION 8.0 • n=2008 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=1000 Participants
|
37 Participants
n=1986 Participants
|
76 Participants
n=2008 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=1000 Participants
|
15 Participants
n=1986 Participants
|
35 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=1000 Participants
|
22 Participants
n=1986 Participants
|
41 Participants
n=2008 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
|
-0.28 units on a scale
Standard Error 0.12
|
-0.63 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
|
-0.47 units on a scale
Standard Error 0.15
|
-0.68 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo, over 16 weeks
|
MT-2990
n=24 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
|
-0.38 units on a scale
Standard Error 0.19
|
-0.57 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
|
-1.05 units on a scale
Standard Error 0.37
|
-2.33 units on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
|
-1.33 units on a scale
Standard Error 0.48
|
-2.28 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo, over 16 weeks
|
MT-2990
n=21 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain)
|
-1.32 units on a scale
Standard Error 0.56
|
-2.74 units on a scale
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo, over 16 weeks
|
MT-2990
n=27 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used
|
-0.33 pills
Standard Error 0.09
|
-0.27 pills
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=29 Participants
Placebo, over 16 weeks
|
MT-2990
n=27 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used
|
-0.01 Pills
Standard Error 0.02
|
-0.04 Pills
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo, over 16 weeks
|
MT-2990
n=7 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Time to Use of Rescue Medication (Analgesic)
|
42.0 days
Interval 42.0 to 42.0
|
19.0 days
Interval 19.0 to 19.0
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
|
34.4 percentage of NMPP responders
|
55.2 percentage of NMPP responders
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
|
34.4 percentage of dysmenorrhea responders
|
37.9 percentage of dysmenorrhea responders
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo, over 16 weeks
|
MT-2990
n=24 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe)
|
36.4 percentage of dyspareunia responders
|
37.5 percentage of dyspareunia responders
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
|
-18.87 mean percentage change
Standard Error 7.48
|
-37.29 mean percentage change
Standard Error 7.86
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=31 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
|
-21.92 Mean percentage change
Standard Error 7.54
|
-30.95 Mean percentage change
Standard Error 7.76
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo, over 16 weeks
|
MT-2990
n=24 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
|
-26.95 Mean percentage change
Standard Error 13.18
|
-20.88 Mean percentage change
Standard Error 12.48
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
|
25.0 percentage of NMPP responders
|
48.3 percentage of NMPP responders
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
|
34.4 percentage of dysmenorrhea responders
|
51.7 percentage of dysmenorrhea responders
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo, over 16 weeks
|
MT-2990
n=21 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
|
31.6 percentage of dyspareunia responders
|
47.6 percentage of dyspareunia responders
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo, over 16 weeks
|
MT-2990
n=36 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
|
-21.2 Mean percentage change
Standard Error 6.72
|
-43.07 Mean percentage change
Standard Error 7.05
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=32 Participants
Placebo, over 16 weeks
|
MT-2990
n=29 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
|
-18.54 Mean percentage change
Standard Error 7.12
|
-31.37 Mean percentage change
Standard Error 7.48
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo, over 16 weeks
|
MT-2990
n=21 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
|
-29.04 Mean percentage change
Standard Error 10.18
|
-40.8 Mean percentage change
Standard Error 9.4
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo, over 16 weeks
|
MT-2990
n=31 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Number of Responders Using Global 7-point Scale
|
12 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo, over 16 weeks
|
MT-2990
n=31 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Percentage of Responders Using Global 7-point Scale
|
40.0 Percentage of responders
|
58.1 Percentage of responders
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 4, 8, 12, and 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo, over 16 weeks
|
MT-2990
n=36 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 4
|
-15.58 units on a scale
Standard Error 3.27
|
-19.32 units on a scale
Standard Error 3.51
|
|
Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 8
|
-19.48 units on a scale
Standard Error 3.56
|
-28.60 units on a scale
Standard Error 3.76
|
|
Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 12
|
-20.03 units on a scale
Standard Error 3.89
|
-34.12 units on a scale
Standard Error 3.99
|
|
Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 16
|
-22.55 units on a scale
Standard Error 3.66
|
-33.55 units on a scale
Standard Error 3.78
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo, over 16 weeks
|
MT-2990
n=31 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Number of Responders Using Endometriosis Specific 7-point Scale
|
14 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo, over 16 weeks
|
MT-2990
n=31 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Percentage of Responders Using Endometriosis Specific 7-point Scale
|
46.7 percentage of responders
|
61.3 percentage of responders
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 4, 8, 12, and 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo, over 16 weeks
|
MT-2990
n=35 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 4
|
-19.80 units on a scale
Standard Error 3.68
|
-24.39 units on a scale
Standard Error 4.03
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 8
|
-25.47 units on a scale
Standard Error 4.42
|
-33.78 units on a scale
Standard Error 4.67
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 12
|
-26.66 units on a scale
Standard Error 5.24
|
-38.03 units on a scale
Standard Error 5.42
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 16
|
-25.27 units on a scale
Standard Error 5.02
|
-35.80 units on a scale
Standard Error 5.23
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 4, 8, 12, and 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo, over 16 weeks
|
MT-2990
n=35 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 4
|
-13.31 units on a scale
Standard Error 3.03
|
-13.06 units on a scale
Standard Error 3.25
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 8
|
-16.54 units on a scale
Standard Error 3.26
|
-19.01 units on a scale
Standard Error 3.42
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 12
|
-15.50 units on a scale
Standard Error 3.54
|
-23.52 units on a scale
Standard Error 3.57
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 16
|
-18.17 units on a scale
Standard Error 3.37
|
-23.75 units on a scale
Standard Error 3.47
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 4, 8, 12, and 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo, over 16 weeks
|
MT-2990
n=35 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 4
|
-13.77 units on a scale
Standard Error 3.66
|
-12.21 units on a scale
Standard Error 3.94
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 8
|
-22.28 units on a scale
Standard Error 4.00
|
-17.85 units on a scale
Standard Error 4.21
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 12
|
-21.35 units on a scale
Standard Error 4.74
|
-23.45 units on a scale
Standard Error 4.83
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 16
|
-19.28 units on a scale
Standard Error 4.50
|
-24.52 units on a scale
Standard Error 4.66
|
SECONDARY outcome
Timeframe: From Baseline to Weeks 4, 8, 12, and 16Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo, over 16 weeks
|
MT-2990
n=35 Participants
MT-2990, over 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 4
|
-17.39 units on a scale
Standard Error 3.90
|
-14.65 units on a scale
Standard Error 4.20
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 8
|
-23.20 units on a scale
Standard Error 4.02
|
-21.01 units on a scale
Standard Error 4.23
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 12
|
-17.65 units on a scale
Standard Error 4.59
|
-26.45 units on a scale
Standard Error 4.54
|
|
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Change from Baseline at Week 16
|
-19.42 units on a scale
Standard Error 4.53
|
-27.55 units on a scale
Standard Error 4.65
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
MT-2990
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=39 participants at risk
Placebo, over 16 weeks
|
MT-2990
n=37 participants at risk
MT-2990, over 16 weeks
|
|---|---|---|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
Other adverse events
| Measure |
Placebo
n=39 participants at risk
Placebo, over 16 weeks
|
MT-2990
n=37 participants at risk
MT-2990, over 16 weeks
|
|---|---|---|
|
General disorders
Pain
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
General disorders
Pyrexia
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Bacterial vaginosis
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Vascular disorders
Hot flush
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Bronchitis
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Cystitis
|
5.1%
2/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Localised infection
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
2/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
2/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Urinary tract infection
|
5.1%
2/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
10.8%
4/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
General disorders
Fatigue
|
7.7%
3/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
General disorders
Infusion site pain
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
4/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Gastrointestinal disorders
Toothache
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
General disorders
Axillary pain
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
General disorders
Catheter site swelling
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
General disorders
Chest pain
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Blood cholesterol increased
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
8.1%
3/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Blood triglycerides increased
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Neutrophil count decreased
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Clonic convulsion
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Headache
|
7.7%
3/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
5.4%
2/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Migraine
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Nervous system disorders
Presyncope
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Renal and urinary disorders
Haematuria
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Renal and urinary disorders
Urge incontinence
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Breast tenderness
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.6%
1/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
0.00%
0/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
|
Vascular disorders
Flushing
|
0.00%
0/39 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
2.7%
1/37 • Adverse Events were collected from Day 1 through to the end of the 16-week double-blind treatment phase.
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma America, Inc.
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER