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A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655224
Recruitment Status : Completed
First Posted : January 13, 2016
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Uterine Fibroids
Interventions Drug: Relugolix
Drug: Relugolix placebo
Enrollment 65
Recruitment Details Participants took part in the study at 15 investigative sites in Japan from 26 March 2016 to 19 May 2017.
Pre-assignment Details Participants with a diagnosis of uterine fibroids were enrolled in a 1:1 ratio in one of two treatment groups: relugolix 40 mg or placebo.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks. Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Period Title: Overall Study
Started 33 32
Completed [1] 32 31
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
[1]
Completed=Completed Treatment
Arm/Group Title Relugolix 40 mg Placebo Total
Hide Arm/Group Description Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks. Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 33 32 65
Hide Baseline Analysis Population Description
Randomized Set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 32 participants 65 participants
40.5  (3.95) 42.6  (5.24) 41.5  (4.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
Female
33
 100.0%
32
 100.0%
65
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 33 participants 32 participants 65 participants
33
 100.0%
32
 100.0%
65
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 33 participants 32 participants 65 participants
157.5  (6.40) 159.2  (4.25) 158.3  (5.48)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 33 participants 32 participants 65 participants
57.55  (11.775) 57.47  (11.511) 57.51  (11.555)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 33 participants 32 participants 65 participants
23.15  (4.146) 22.56  (3.714) 22.86  (3.919)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Never Smoked Number Analyzed 33 participants 32 participants 65 participants
20
  60.6%
21
  65.6%
41
  63.1%
Current Smoker Number Analyzed 33 participants 32 participants 65 participants
6
  18.2%
8
  25.0%
14
  21.5%
Ex-Smoker Number Analyzed 33 participants 32 participants 65 participants
7
  21.2%
3
   9.4%
10
  15.4%
Birth Experience  
Measure Type: Count of Participants
Unit of measure:  Participants
Had Birth Experience Number Analyzed 33 participants 32 participants 65 participants
12
  36.4%
12
  37.5%
24
  36.9%
Had No Birth Experience Number Analyzed 33 participants 32 participants 65 participants
21
  63.6%
20
  62.5%
41
  63.1%
Type of Uterine Fibroid  
Measure Type: Count of Participants
Unit of measure:  Participants
Subserosal Fibroid Number Analyzed 33 participants 32 participants 65 participants
17
  51.5%
9
  28.1%
26
  40.0%
Intramural Fibroid Number Analyzed 33 participants 32 participants 65 participants
22
  66.7%
29
  90.6%
51
  78.5%
Stopped Any Medications for Uterine Fibroids  
Measure Type: Count of Participants
Unit of measure:  Participants
Had Stopped Any Medications Number Analyzed 33 participants 32 participants 65 participants
5
  15.2%
7
  21.9%
12
  18.5%
Had not Stopped Any Medications Number Analyzed 33 participants 32 participants 65 participants
28
  84.8%
25
  78.1%
53
  81.5%
Number of Participants With No Surgery for Uterine Fibroids  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
33
 100.0%
32
 100.0%
65
 100.0%
Volume of Myoma  
Mean (Standard Deviation)
Unit of measure:  Cm^3
Number Analyzed 33 participants 32 participants 65 participants
78.83  (84.189) 101.38  (172.738) 89.94  (134.633)
Volume of Uterus  
Mean (Standard Deviation)
Unit of measure:  Cm^3
Number Analyzed 33 participants 32 participants 65 participants
252.29  (202.938) 300.09  (295.341) 275.82  (251.837)
Maximum Numerical Rating Scale (NRS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 33 participants 32 participants 65 participants
6.64  (1.817) 6.28  (1.689) 6.46  (1.751)
[1]
Measure Description: Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain.
Uterine Fibroid Symptom and Quality of Life (UFS-QOL) Score: Symptom Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 33 participants 32 participants 65 participants
25.5  (8.59) 30.3  (13.07) 27.9  (11.20)
[1]
Measure Description: UFS-QOL was a 37-item self-reporting tool for evaluating QOL in participants with uterine fibroid. It includes eight symptom-related questions and 29 HRQL questions across six subscales (concern, activities, energy/mood, control, self-consciousness, sexual function). The total symptom severity score is ranging from 0 to 100. The higher scores indicate greater severity.
UFS-QOL Score: Health Relate Quality of Life (HRQL) Total   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 33 participants 32 participants 65 participants
83.9  (12.47) 80.0  (15.00) 82.0  (13.81)
[1]
Measure Description: UFS-QOL was a 37-item self-reporting tool for evaluating QOL in participants with uterine fibroid. It includes eight symptom-related questions and 29 HRQL questions across six subscales (concern, activities, energy/mood, control, self-consciousness, sexual function). The total HRQL score is ranging from 0 to 100. The higher scores indicate better QOL.
1.Primary Outcome
Title Percentage of Participants With a Maximum NRS Score of 1 or Less During the 28 Days Before the Final Dose of Study Drug
Hide Description Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 1 or less is reported.
Time Frame For 28 days before the final dose of study drug (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Number
Unit of Measure: percentage of participants
57.6 3.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher's Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 42.071
Confidence Interval (2-Sided) 95%
5.113 to 346.181
Estimation Comments Relugolix 40 mg/Placebo
2.Secondary Outcome
Title Percentage of Participants With a Maximum NRS Score of 0 During the 28 Days Before the Final Dose of Study Drug
Hide Description Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 0 is reported.
Time Frame For 28 days before the final dose of study drug (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Number
Unit of Measure: percentage of participants
48.5 3.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 29.176
Confidence Interval (2-Sided) 95%
3.555 to 239.478
Estimation Comments Relugolix 40 mg/Placebo
3.Secondary Outcome
Title Mean NRS Score During the 28 Days Before the Final Dose of Study Drug
Hide Description Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain.
Time Frame For 28 days before the final dose of study drug (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.50  (0.967) 0.99  (1.274)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-1.050 to 0.069
Estimation Comments Relugolix 40 mg-Placebo
4.Secondary Outcome
Title Percentage of Days Without Pain Symptoms (NRS = 0) During the 28 Days Before the Final Dose of Study Drug
Hide Description Percentage of day without pain symptoms (NRS = 0) was reported. Number of days without pain symptoms is determined by a zero score on the NRS. Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. Percentage of days without pain symptoms (NRS=0) during the 28 days before the final dose of study drug (%) = [(number of days without pain symptoms (NRS=0) during the last 28 days of the treatment)/(number of days with available data during the last 28 days of the treatment)]*100.
Time Frame For 28 days before the final dose of study drug (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: percentage of days
76.73  (32.006) 64.78  (29.015)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.96
Confidence Interval (2-Sided) 95%
-3.201 to 27.112
Estimation Comments Relugolix 40 mg-Placebo
5.Secondary Outcome
Title Percentage of Participants With Maximum NRS Score of 1 or Less From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Hide Description Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 1 or less is reported.
Time Frame Day 1 to 28, Day 29 to 56, and Day 57 to 84
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 to 28 Number Analyzed 33 participants 32 participants
24.2 0.0
Day 29 to 56 Number Analyzed 33 participants 31 participants
45.5 12.9
Day 57 to 84 Number Analyzed 32 participants 31 participants
59.4 12.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 29 to 56
Type of Statistical Test Other
Comments The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.625
Confidence Interval (2-Sided) 95%
1.605 to 19.709
Estimation Comments Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 57 to 84
Type of Statistical Test Other
Comments The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.865
Confidence Interval (2-Sided) 95%
2.784 to 34.955
Estimation Comments Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.
6.Secondary Outcome
Title Percentage of Participants With a Maximum NRS Score of 0 From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Hide Description Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 0 is reported.
Time Frame Day 1 to 28, Day 29 to 56, and Day 57 to 84
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 to 28 Number Analyzed 33 participants 32 participants
15.2 0.0
Day 29 to 56 Number Analyzed 33 participants 31 participants
27.3 6.5
Day 57 to 84 Number Analyzed 32 participants 31 participants
46.9 6.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 29 to 56
Type of Statistical Test Other
Comments The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.438
Confidence Interval (2-Sided) 95%
1.071 to 27.609
Estimation Comments Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 57 to 84
Type of Statistical Test Other
Comments The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.794
Confidence Interval (2-Sided) 95%
2.603 to 62.880
Estimation Comments Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.
7.Secondary Outcome
Title Mean NRS Score From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Hide Description Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain.
Time Frame Day 1 to 28, Day 29 to 56, and Day 57 to 84
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 1 to 28 Number Analyzed 33 participants 32 participants
1.26  (1.490) 1.17  (1.141)
Day 29 to 56 Number Analyzed 33 participants 31 participants
0.59  (0.991) 1.16  (1.457)
Day 57 to 84 Number Analyzed 32 participants 31 participants
0.43  (0.776) 0.97  (1.279)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 1 to 28
Type of Statistical Test Other
Comments The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.
Method of Estimation Estimation Parameter Mean Difference (Each Period)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.574 to 0.745
Estimation Comments Relugolix 40 mg-Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 29 to 56
Type of Statistical Test Other
Comments The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.
Method of Estimation Estimation Parameter Mean Difference (Each Period)
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.190 to 0.049
Estimation Comments Relugolix 40 mg-Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 57 to 84
Type of Statistical Test Other
Comments The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.
Method of Estimation Estimation Parameter Mean Difference (Each Period)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-1.074 to -0.012
Estimation Comments Relugolix 40 mg-Placebo
8.Secondary Outcome
Title Percentage of Days Without Pain Symptoms (NRS = 0) From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Hide Description Percentage of day without pain symptoms (NRS = 0) was reported. Number of days without pain symptoms is determined by a zero score on the NRS. Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. Percentage of days without pain symptoms (NRS=0) (%) = [(number of days without pain symptoms (NRS=0) during the last 28 days of the treatment)/(number of days with available data during the last 28 days of the treatment)]*100.
Time Frame Day 1 to 28, Day 29 to 56, and Day 57 to 84
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: percentage of days
Day 1 to 28 Number Analyzed 33 participants 32 participants
60.49  (34.043) 56.32  (28.891)
Day 29 to 56 Number Analyzed 33 participants 31 participants
73.98  (31.718) 61.29  (31.459)
Day 57 to 84 Number Analyzed 32 participants 31 participants
77.43  (30.854) 65.84  (29.224)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 1 to 28
Type of Statistical Test Other
Comments The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.
Method of Estimation Estimation Parameter Mean Difference (Each Period)
Estimated Value 4.17
Confidence Interval (2-Sided) 95%
-11.507 to 19.839
Estimation Comments Relugolix 40 mg-Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 29 to 56
Type of Statistical Test Other
Comments The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.
Method of Estimation Estimation Parameter Mean Difference (Each Period)
Estimated Value 12.70
Confidence Interval (2-Sided) 95%
-3.098 to 28.494
Estimation Comments Relugolix 40 mg-Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relugolix 40 mg, Placebo
Comments Day 57 to 84
Type of Statistical Test Other
Comments The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.
Method of Estimation Estimation Parameter Mean Difference (Each Period)
Estimated Value 11.60
Confidence Interval (2-Sided) 95%
-3.554 to 26.745
Estimation Comments Relugolix 40 mg-Placebo
9.Secondary Outcome
Title Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
Hide Description An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
29
  87.9%
18
  56.3%
10.Secondary Outcome
Title Number of Participants With Markedly Abnormal Values of Vital Signs
Hide Description Vital signs included sitting blood pressure (after the participant has rested for at least 5 minutes), body temperature (oral or tympanic measurement) (degree Celsius [°C]) and pulse (beats per minute [bpm]) are reported.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
Diastolic Blood Pressure Lower (<50 mmHg)
2
   6.1%
1
   3.1%
Body temperature Lower (<35.6 °C)
4
  12.1%
2
   6.3%
11.Secondary Outcome
Title Number of Participants With TEAEs Related to Weight
Hide Description Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to weight was reported.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With TEAEs Related to Standard 12-lead Electrocardiogram (ECG)
Hide Description Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to ECG was reported.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Markedly Abnormal Values of Laboratory Tests
Hide Description Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. WBC = White blood cells, GGT = gamma-glutamyl transferase, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit.
Time Frame Up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description:
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks.
Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin Lower (<0.8×LLN g/dL)
0
   0.0%
1
   3.1%
WBC Upper (>1.5×ULN × 10^3cells/μL)
0
   0.0%
1
   3.1%
Total Cholesterol Upper (>300 mg/dL)
2
   6.1%
0
   0.0%
Triglycerides Upper (>2.5×ULN mg/dL)
0
   0.0%
3
   9.4%
Total Bilirubin Upper (>2.0 mg/dL)
1
   3.0%
0
   0.0%
GGT Upper (>3×ULN U/L)
1
   3.0%
0
   0.0%
Time Frame Up to Week 16
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Relugolix 40 mg Placebo
Hide Arm/Group Description Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks. Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks.
All-Cause Mortality
Relugolix 40 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/32 (0.00%) 
Hide Serious Adverse Events
Relugolix 40 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/32 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Relugolix 40 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   27/33 (81.82%)   14/32 (43.75%) 
Infections and infestations     
Viral upper respiratory tract infection  1  7/33 (21.21%)  9/32 (28.13%) 
Investigations     
Alanine aminotransferase increased  1  2/33 (6.06%)  0/32 (0.00%) 
Aspartate aminotransferase increased  1  2/33 (6.06%)  0/32 (0.00%) 
Nervous system disorders     
Headache  1  0/33 (0.00%)  2/32 (6.25%) 
Psychiatric disorders     
Insomnia  1  3/33 (9.09%)  0/32 (0.00%) 
Reproductive system and breast disorders     
Metrorrhagia  1  13/33 (39.39%)  3/32 (9.38%) 
Menorrhagia  1  4/33 (12.12%)  3/32 (9.38%) 
Menstruation irregular  1  1/33 (3.03%)  3/32 (9.38%) 
Genital haemorrhage  1  2/33 (6.06%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/33 (0.00%)  2/32 (6.25%) 
Oropharyngeal pain  1  2/33 (6.06%)  0/32 (0.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  5/33 (15.15%)  0/32 (0.00%) 
Vascular disorders     
Hot flush  1  15/33 (45.45%)  0/32 (0.00%) 
1
Term from vocabulary, MedDRA version: 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02655224    
Other Study ID Numbers: TAK-385-3008
U1111-1178-1086 ( Registry Identifier: WHO )
JapicCTI-163127 ( Registry Identifier: JapicCTI )
First Submitted: January 12, 2016
First Posted: January 13, 2016
Results First Submitted: May 16, 2018
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019