MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
Sponsor
Mitsubishi Tanabe Pharma Development America, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03291067
Collaborator
(none)
375
63
4
13
6
0.5
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows:
-
Moderate: sensation of heat with sweating, able to continue activity
-
Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.
Study Design
Study Type:
Interventional
Actual Enrollment
:
375 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of MT-8554 on the Frequency and Severity of Vasomotor Symptoms in Postmenopausal Women
Actual Study Start Date
:
Oct 9, 2017
Actual Primary Completion Date
:
Oct 19, 2018
Actual Study Completion Date
:
Nov 9, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MT-8554 1mg
|
Drug: MT-8554 1mg
MT-8554 1mg QD, oral, 12 weeks
|
| Experimental: MT-8554 5mg
|
Drug: MT-8554 5mg
MT-8554 5mg QD, oral, 12 weeks
|
| Experimental: MT-8554 10mg
|
Drug: MT-8554 10mg
MT-8554 10mg QD, oral, 12 weeks
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo QD, oral, 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 [Baseline, Weeks 4 and 12]
The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
- Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12 [Baseline, Weeks 4 and 12]
The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated.
Secondary Outcome Measures
- Percentage of Responders at Weeks 4 and 12 [Week 4 and Week 12]
Subjects with cutoff number or greater reduction in the average daily frequency of moderate and severe VMS compared to baseline. The cutoff number was calculated using anchor-based method. The cutoff number was defined as numerical value to maximize the sensitivity and the specificity, using Patient Global Impression of Change (PGIC) as the anchor.
- Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12 [Baseline, Weeks 4 and 12]
The Insomnia Severity Index was a self-rated, 7-item validated sleep scale that measured clinical insomnia severity. The total score ranged from 0-28 where higher values indicated increased severity of insomnia.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Additional screening criteria check may apply for qualification:
-
Provide written informed consent to participate in this study
-
Spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (FSH) levels >40 mIU/mL; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy
-
7 or more moderate to severe VMS per day, or 50 or more moderate to severe VMS per week
-
Have a consistent bedtime on at least 5 nights per week
-
Mean VMS frequency during the Placebo Run in period does not drop by more than 50% from the mean level reported for 2 weeks during the Screening period
-
VMS diary compliance >50%
-
In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
-
History of any cancer within 5 years except for basal cell carcinoma
-
History of undiagnosed abnormal vaginal bleeding
-
History of Hepatitis B, Hepatitis C or HIV
-
History of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance
-
Presence or history of severe adverse reaction or allergy to any drug
-
Peripheral vascular disease or disorders with associated vasculopathies
-
Clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator
-
Endometrial thickness of >=5 mm as measured by transvaginal ultrasound
-
Abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer)
-
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 × upper limit of normal (ULN) above the reference range
-
Subjects of childbearing potential
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Birmingham | Alabama | United States | 35209 |
| 2 | Research Site | Dothan | Alabama | United States | 36303 |
| 3 | Research Site | Phoenix | Arizona | United States | 85032 |
| 4 | Research Site | Norwalk | California | United States | 90650 |
| 5 | Research Site | Sacramento | California | United States | 95821 |
| 6 | Research Site | San Diego | California | United States | 92111 |
| 7 | Research Site | Denver | Colorado | United States | 80209 |
| 8 | Research Site | New London | Connecticut | United States | 06320 |
| 9 | Research Site | New London | Connecticut | United States | 33176 |
| 10 | Research Site | Aventura | Florida | United States | 33180 |
| 11 | Research Site | Clearwater | Florida | United States | 33759 |
| 12 | Research Site | Crystal River | Florida | United States | 34429 |
| 13 | Research Site | Fort Myers | Florida | United States | 33912 |
| 14 | Research Site | Hialeah | Florida | United States | 33012 |
| 15 | Research Site | Hialeah | Florida | United States | 33016 |
| 16 | Research Site | Jacksonville | Florida | United States | 32216 |
| 17 | Research Site | Jacksonville | Florida | United States | 32256 |
| 18 | Research Site | Jupiter | Florida | United States | 33458 |
| 19 | Research Site | Miami | Florida | United States | 33176 |
| 20 | Research Site | Miami | Florida | United States | 33185 |
| 21 | Research Site | Miami | Florida | United States | 33186 |
| 22 | Research Site | Orlando | Florida | United States | 32801 |
| 23 | Research Site | Orlando | Florida | United States | 32806 |
| 24 | Research Site | Ponte Vedra | Florida | United States | 32081 |
| 25 | Research Site | Port Saint Lucie | Florida | United States | 34952 |
| 26 | Research Site | Sarasota | Florida | United States | 34231 |
| 27 | Research Site | Sarasota | Florida | United States | 34239 |
| 28 | Research Site | Wellington | Florida | United States | 33414 |
| 29 | Research Site | West Palm Beach | Florida | United States | 33409 |
| 30 | Research Site | Sandy Springs | Georgia | United States | 30328 |
| 31 | Research Site | Idaho Falls | Idaho | United States | 83404 |
| 32 | Research Site | Ankeny | Iowa | United States | 50023 |
| 33 | Research Site | Wichita | Kansas | United States | 67226 |
| 34 | Research Site | Marrero | Louisiana | United States | 70072 |
| 35 | Research Site | Metairie | Louisiana | United States | 70001 |
| 36 | Research Site | Baltimore | Maryland | United States | 21208 |
| 37 | Research Site | Kalamazoo | Michigan | United States | 49009 |
| 38 | Research Site | Saginaw | Michigan | United States | 48504 |
| 39 | Research Site | Saginaw | Michigan | United States | 48604 |
| 40 | Research Site | Kansas City | Missouri | United States | 64114 |
| 41 | Research Site | Missoula | Montana | United States | 59808 |
| 42 | Research Site | Las Vegas | Nevada | United States | 89113 |
| 43 | Research Site | Las Vegas | Nevada | United States | 89128 |
| 44 | Research Site | Lawrenceville | New Jersey | United States | 08648 |
| 45 | Research Site | Morehead City | North Carolina | United States | 28557 |
| 46 | Research Site | Winston-Salem | North Carolina | United States | 27103 |
| 47 | Research Site | Cleveland | Ohio | United States | 44122 |
| 48 | Research Site | Columbus | Ohio | United States | 43213 |
| 49 | Research Site | Columbus | Ohio | United States | 43231 |
| 50 | Research Site | Englewood | Ohio | United States | 45322 |
| 51 | Research Site | Philadelphia | Pennsylvania | United States | 19114 |
| 52 | Research Site | Bristol | Tennessee | United States | 37620 |
| 53 | Research Site | Jackson | Tennessee | United States | 38305 |
| 54 | Research Site | Knoxville | Tennessee | United States | 37920 |
| 55 | Research Site | Memphis | Tennessee | United States | 38119 |
| 56 | Research Site | Fort Worth | Texas | United States | 76104 |
| 57 | Research Site | Schertz | Texas | United States | 78154 |
| 58 | Research Site | Draper | Utah | United States | 84020 |
| 59 | Research Site | Ogden | Utah | United States | 84403 |
| 60 | Research Site | Salt Lake City | Utah | United States | 84107 |
| 61 | Research Site | Norfolk | Virginia | United States | 23502 |
| 62 | Research Site | Covington | Washington | United States | 98042 |
| 63 | Research Site | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
- Study Director: Head of Clinical Development,, Mitsubishi Tanabe Pharma Development America, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier:
NCT03291067
Other Study ID Numbers:
- MT-8554-A01
First Posted:
Sep 25, 2017
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | One subject with dual status of the run-in-failure and randomized in error in MT-8554 5 mg group was excluded from the Randomized Population. |
| Arm/Group Title | MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | MT-8554 1mg QD, oral, 12 weeks | MT-8554 5mg QD, oral, 12 weeks | MT-8554 10mg QD, oral, 12 weeks | Placebo QD, oral, 12 weeks |
| Period Title: Overall Study | ||||
| STARTED | 94 | 92 | 94 | 94 |
| Treated | 95 | 90 | 93 | 90 |
| COMPLETED | 84 | 78 | 61 | 77 |
| NOT COMPLETED | 10 | 14 | 33 | 17 |
Baseline Characteristics
| Arm/Group Title | MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo | Total |
|---|---|---|---|---|---|
| Arm/Group Description | MT-8554 1mg QD, oral, 12 weeks | MT-8554 5mg QD, oral, 12 weeks | MT-8554 10mg QD, oral, 12 weeks | Placebo QD, oral, 12 weeks | Total of all reporting groups |
| Overall Participants | 95 | 90 | 93 | 90 | 368 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
54.5
(6.27)
|
54.6
(6.62)
|
56.0
(6.55)
|
55.7
(6.25)
|
55.2
(6.43)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
95
100%
|
90
100%
|
93
100%
|
90
100%
|
368
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
1
1.1%
|
0
0%
|
0
0%
|
1
0.3%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
20
21.1%
|
25
27.8%
|
19
20.4%
|
28
31.1%
|
92
25%
|
| White |
74
77.9%
|
64
71.1%
|
74
79.6%
|
62
68.9%
|
274
74.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
1.1%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
Outcome Measures
| Title | Change From Baseline in the Average Daily Frequency of Moderate to Severe VMS at Weeks 4 and 12 |
|---|---|
| Description | The average daily frequency of moderate to severe VMS at a time point (Baseline, Weeks 4 and 12) was the average of the frequency of moderate to severe VMS of available diary days in a 7-day window. Changes in the average daily frequency of moderate to severe VMS at Week 4 and Week 12 compared to baseline were evaluated. |
| Time Frame | Baseline, Weeks 4 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment |
| Arm/Group Title | MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | MT-8554 1mg QD, oral, 12 weeks | MT-8554 5mg QD, oral, 12 weeks | MT-8554 10mg QD, oral, 12 weeks | Placebo QD, oral, 12 weeks |
| Measure Participants | 93 | 90 | 89 | 91 |
| Week 4 |
-1.92
(0.609)
|
-2.75
(0.705)
|
-2.75
(0.734)
|
-1.39
(0.705)
|
| Week 12 |
-2.91
(0.690)
|
-3.11
(0.780)
|
-3.38
(0.821)
|
-2.78
(0.779)
|
| Title | Change From Baseline in the Average Daily Severity Score of Mild to Severe VMS at Weeks 4 and 12 |
|---|---|
| Description | The daily severity score of VMS was defined as (2xFmo + 3xFse)/(Fmo + Fse) for baseline, and (1xFmi + 2xFmo + 3xFse)/(Fmi + Fmo + Fse) for Weeks 4 and 12, where Fmi, Fmo, and Fse were the daily frequencies of mild, moderate, and severe VMS, respectively. The average daily severity score of mild to severe VMS at a time point (Baseline, Week 4 and Week 12) was the average of the daily severity of available diary days in the corresponding 7-day window. The severity score of VMS ranged from 0 (lowest severity) to 3 (highest severity). Change in the average daily severity score of mild to severe VMS at Week 4 and Week 12 compared to baseline were evaluated. |
| Time Frame | Baseline, Weeks 4 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment |
| Arm/Group Title | MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | MT-8554 1mg QD, oral, 12 weeks | MT-8554 5mg QD, oral, 12 weeks | MT-8554 10mg QD, oral, 12 weeks | Placebo QD, oral, 12 weeks |
| Measure Participants | 93 | 90 | 89 | 91 |
| Week 4 |
-0.302
(0.0609)
|
-0.407
(0.0714)
|
-0.305
(0.0740)
|
-0.316
(0.0712)
|
| Week 12 |
-0.374
(0.0725)
|
-0.481
(0.0822)
|
-0.433
(0.0864)
|
-0.388
(0.0819)
|
| Title | Percentage of Responders at Weeks 4 and 12 |
|---|---|
| Description | Subjects with cutoff number or greater reduction in the average daily frequency of moderate and severe VMS compared to baseline. The cutoff number was calculated using anchor-based method. The cutoff number was defined as numerical value to maximize the sensitivity and the specificity, using Patient Global Impression of Change (PGIC) as the anchor. |
| Time Frame | Week 4 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment. The subjects without VMS frequency data at Week 4 were excluded from the analysis at Week 4. The subjects without VMS frequency data at Week 12 were excluded from the analysis at Week 12. |
| Arm/Group Title | MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | MT-8554 1mg QD, oral, 12 weeks | MT-8554 5mg QD, oral, 12 weeks | MT-8554 10mg QD, oral, 12 weeks | Placebo QD, oral, 12 weeks |
| Measure Participants | 93 | 90 | 89 | 91 |
| Week 4 |
31.8
|
52.4
|
36.1
|
36.0
|
| Week 12 |
44.4
|
60.5
|
54.1
|
54.1
|
| Title | Change From Baseline in the Insomnia Severity Index at Week 4 and Week 12 |
|---|---|
| Description | The Insomnia Severity Index was a self-rated, 7-item validated sleep scale that measured clinical insomnia severity. The total score ranged from 0-28 where higher values indicated increased severity of insomnia. |
| Time Frame | Baseline, Weeks 4 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population=All randomized subjects who have at least 1 post-baseline efficacy assessment |
| Arm/Group Title | MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | MT-8554 1mg QD, oral, 12 weeks | MT-8554 5mg QD, oral, 12 weeks | MT-8554 10mg QD, oral, 12 weeks | Placebo QD, oral, 12 weeks |
| Measure Participants | 93 | 90 | 89 | 91 |
| Week 4 |
-1.8
(0.49)
|
-3.1
(0.51)
|
-3.6
(0.55)
|
-1.8
(0.50)
|
| Week 12 |
-3.2
(0.53)
|
-2.7
(0.55)
|
-2.4
(0.54)
|
-3.0
(0.55)
|
Adverse Events
| Time Frame | Week 12 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | One subject was randomized to placebo group; but the subject got one week of MT-8554 1 mg treatment so that the subject was counted as MT-8554 1 mg group in the Safety Population. Total of 6 subjects (3 on placebo, 2 on MT-8554 5 mg and 1 on MT-8554 10 mg) did not take any study medication so that these subjects were excluded from the Safety Population. | |||||||
| Arm/Group Title | MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo | ||||
| Arm/Group Description | MT-8554 1mg QD, oral, 12 weeks | MT-8554 5mg QD, oral, 12 weeks | MT-8554 10mg QD, oral, 12 weeks | Placebo QD, oral, 12 weeks | ||||
All Cause Mortality |
||||||||
| MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
Serious Adverse Events |
||||||||
| MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Nervous system disorders | ||||||||
| Transient ischaemic attack | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| MT-8554 1mg | MT-8554 5mg | MT-8554 10mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 37/95 (38.9%) | 41/90 (45.6%) | 46/93 (49.5%) | 37/90 (41.1%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Lymphadenopathy | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Endocrine disorders | ||||||||
| Goitre | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Eye disorders | ||||||||
| Conjunctival hyperaemia | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal distension | 0/95 (0%) | 1/90 (1.1%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Abdominal pain | 2/95 (2.1%) | 2/90 (2.2%) | 0/93 (0%) | 0/90 (0%) | ||||
| Abdominal pain upper | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Constipation | 0/95 (0%) | 1/90 (1.1%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Diarrhoea | 1/95 (1.1%) | 0/90 (0%) | 2/93 (2.2%) | 1/90 (1.1%) | ||||
| Dry mouth | 0/95 (0%) | 0/90 (0%) | 2/93 (2.2%) | 1/90 (1.1%) | ||||
| Dyspepsia | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Flatulence | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Gastritis | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Hypoaesthesia oral | 0/95 (0%) | 2/90 (2.2%) | 4/93 (4.3%) | 0/90 (0%) | ||||
| Nausea | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 2/90 (2.2%) | ||||
| Oral discomfort | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Paraesthesia oral | 0/95 (0%) | 2/90 (2.2%) | 11/93 (11.8%) | 0/90 (0%) | ||||
| Swollen tongue | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Toothache | 1/95 (1.1%) | 1/90 (1.1%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Vomiting | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| General disorders | ||||||||
| Chills | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Cyst | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Fatigue | 1/95 (1.1%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Feeling cold | 1/95 (1.1%) | 2/90 (2.2%) | 3/93 (3.2%) | 1/90 (1.1%) | ||||
| Feeling hot | 0/95 (0%) | 0/90 (0%) | 7/93 (7.5%) | 0/90 (0%) | ||||
| Feeling jittery | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Feeling of body temperature change | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Hypothermia | 0/95 (0%) | 0/90 (0%) | 2/93 (2.2%) | 0/90 (0%) | ||||
| Malaise | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Immune system disorders | ||||||||
| Drug hypersensitivity | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 2/90 (2.2%) | ||||
| Bronchitis viral | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Chronic sinusitis | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Ear infection | 0/95 (0%) | 1/90 (1.1%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Furuncle | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Gastroenteritis viral | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Herpes zoster | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Influenza | 1/95 (1.1%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Nasopharyngitis | 0/95 (0%) | 3/90 (3.3%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Oral herpes | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Pneumonia | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Rhinitis | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Sinusitis | 1/95 (1.1%) | 0/90 (0%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Tooth abscess | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Upper respiratory tract infection | 2/95 (2.1%) | 3/90 (3.3%) | 2/93 (2.2%) | 1/90 (1.1%) | ||||
| Urinary tract infection | 1/95 (1.1%) | 3/90 (3.3%) | 1/93 (1.1%) | 2/90 (2.2%) | ||||
| Vaginal infection | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Viral rhinitis | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Viral upper respiratory tract infection | 1/95 (1.1%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Accidental overdose | 1/95 (1.1%) | 2/90 (2.2%) | 1/93 (1.1%) | 2/90 (2.2%) | ||||
| Arthropod bite | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Contusion | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Fall | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Joint dislocation | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Laceration | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Ligament sprain | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Meniscus injury | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Periorbital haemorrhage | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Investigations | ||||||||
| Activated partial thromboplastin time prolonged | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Alanine aminotransferase increased | 2/95 (2.1%) | 2/90 (2.2%) | 0/93 (0%) | 2/90 (2.2%) | ||||
| Aspartate aminotransferase increased | 1/95 (1.1%) | 1/90 (1.1%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Biopsy endometrium abnormal | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Blood alkaline phosphatase increased | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Blood cholesterol increased | 1/95 (1.1%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Blood creatine phosphokinase increased | 3/95 (3.2%) | 4/90 (4.4%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Blood glucose increased | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Blood pressure increased | 1/95 (1.1%) | 1/90 (1.1%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Blood triglycerides increased | 2/95 (2.1%) | 1/90 (1.1%) | 1/93 (1.1%) | 2/90 (2.2%) | ||||
| Blood urine present | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Body temperature decreased | 1/95 (1.1%) | 0/90 (0%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Electrocardiogram ST-T change | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Electrocardiogram T wave amplitude decreased | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Electrocardiogram abnormal | 0/95 (0%) | 1/90 (1.1%) | 2/93 (2.2%) | 0/90 (0%) | ||||
| Gamma-glutamyltransferase increased | 1/95 (1.1%) | 1/90 (1.1%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Haemoglobin decreased | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Hepatic enzyme increased | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| International normalised ratio increased | 0/95 (0%) | 1/90 (1.1%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Low density lipoprotein increased | 2/95 (2.1%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Neutrophil count increased | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Oestradiol increased | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Prothrombin time prolonged | 0/95 (0%) | 1/90 (1.1%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Red blood cells urine positive | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Weight increased | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| White blood cell count increased | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| White blood cells urine positive | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Increased appetite | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Vitamin D deficiency | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 3/90 (3.3%) | ||||
| Arthritis | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Back pain | 0/95 (0%) | 2/90 (2.2%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Fibromyalgia | 1/95 (1.1%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Flank pain | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Intervertebral disc degeneration | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Muscle spasms | 2/95 (2.1%) | 1/90 (1.1%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Myalgia | 1/95 (1.1%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Neck mass | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Pain in extremity | 0/95 (0%) | 1/90 (1.1%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Tendonitis | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Dysgeusia | 0/95 (0%) | 1/90 (1.1%) | 2/93 (2.2%) | 0/90 (0%) | ||||
| Headache | 3/95 (3.2%) | 1/90 (1.1%) | 1/93 (1.1%) | 6/90 (6.7%) | ||||
| Hypoaesthesia | 0/95 (0%) | 0/90 (0%) | 5/93 (5.4%) | 0/90 (0%) | ||||
| Migraine | 2/95 (2.1%) | 1/90 (1.1%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Paraesthesia | 0/95 (0%) | 2/90 (2.2%) | 14/93 (15.1%) | 2/90 (2.2%) | ||||
| Parosmia | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Sciatica | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Sinus headache | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Psychiatric disorders | ||||||||
| Affect lability | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Anxiety | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Depression | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Insomnia | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Irritability | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Nightmare | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Sleep disorder | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Sleep inertia | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Glycosuria | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Breast mass | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Breast tenderness | 1/95 (1.1%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Rectocele | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Uterine haemorrhage | 1/95 (1.1%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Uterine polyp | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Uterine prolapse | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Vaginal haemorrhage | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Vulvovaginal dryness | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Allergic sinusitis | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Cough | 1/95 (1.1%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Epistaxis | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Nasal congestion | 1/95 (1.1%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Oropharyngeal pain | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 2/90 (2.2%) | ||||
| Pharyngeal hypoaesthesia | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Pharyngeal oedema | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Rhinorrhoea | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Upper-airway cough syndrome | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Wheezing | 0/95 (0%) | 1/90 (1.1%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Cold sweat | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Dermatitis | 1/95 (1.1%) | 0/90 (0%) | 0/93 (0%) | 0/90 (0%) | ||||
| Dry skin | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 1/90 (1.1%) | ||||
| Hyperhidrosis | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Nail disorder | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Rash | 0/95 (0%) | 0/90 (0%) | 2/93 (2.2%) | 0/90 (0%) | ||||
| Skin burning sensation | 0/95 (0%) | 0/90 (0%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Urticaria | 0/95 (0%) | 0/90 (0%) | 0/93 (0%) | 1/90 (1.1%) | ||||
| Surgical and medical procedures | ||||||||
| Tooth extraction | 0/95 (0%) | 1/90 (1.1%) | 0/93 (0%) | 0/90 (0%) | ||||
| Vascular disorders | ||||||||
| Flushing | 0/95 (0%) | 0/90 (0%) | 2/93 (2.2%) | 0/90 (0%) | ||||
| Hot flush | 1/95 (1.1%) | 0/90 (0%) | 3/93 (3.2%) | 0/90 (0%) | ||||
| Hypertension | 0/95 (0%) | 1/90 (1.1%) | 1/93 (1.1%) | 0/90 (0%) | ||||
| Peripheral coldness | 0/95 (0%) | 0/90 (0%) | 2/93 (2.2%) | 0/90 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Clinical Trials, Information Desk |
|---|---|
| Organization | Mitsubishi Tanabe Pharma Development America, Inc. |
| Phone | Please e-mail |
| information@mt-pharma-us.com |
Responsible Party:
Mitsubishi Tanabe Pharma Development America, Inc.
ClinicalTrials.gov Identifier:
NCT03291067
Other Study ID Numbers:
- MT-8554-A01
First Posted:
Sep 25, 2017
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021