Trial Outcomes & Findings for A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids (NCT NCT02655224)
NCT ID: NCT02655224
Last Updated: 2019-03-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
65 participants
Primary outcome timeframe
For 28 days before the final dose of study drug (up to Week 12)
Results posted on
2019-03-22
Participant Flow
Participants took part in the study at 15 investigative sites in Japan from 26 March 2016 to 19 May 2017.
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.
Participant milestones
| Measure |
Relugolix 40 mg
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.
|
Placebo
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 Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Relugolix 40 mg
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.
|
Placebo
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 Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 3.95 • n=33 Participants
|
42.6 years
STANDARD_DEVIATION 5.24 • n=32 Participants
|
41.5 years
STANDARD_DEVIATION 4.72 • n=65 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=33 Participants
|
32 Participants
n=32 Participants
|
65 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=33 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=65 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
33 Participants
n=33 Participants
|
32 Participants
n=32 Participants
|
65 Participants
n=65 Participants
|
|
Height
|
157.5 centimeter (cm)
STANDARD_DEVIATION 6.40 • n=33 Participants
|
159.2 centimeter (cm)
STANDARD_DEVIATION 4.25 • n=32 Participants
|
158.3 centimeter (cm)
STANDARD_DEVIATION 5.48 • n=65 Participants
|
|
Weight
|
57.55 kilogram (kg)
STANDARD_DEVIATION 11.775 • n=33 Participants
|
57.47 kilogram (kg)
STANDARD_DEVIATION 11.511 • n=32 Participants
|
57.51 kilogram (kg)
STANDARD_DEVIATION 11.555 • n=65 Participants
|
|
Body Mass Index (BMI)
|
23.15 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.146 • n=33 Participants
|
22.56 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.714 • n=32 Participants
|
22.86 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.919 • n=65 Participants
|
|
Smoking Classification
Never Smoked
|
20 Participants
n=33 Participants
|
21 Participants
n=32 Participants
|
41 Participants
n=65 Participants
|
|
Smoking Classification
Current Smoker
|
6 Participants
n=33 Participants
|
8 Participants
n=32 Participants
|
14 Participants
n=65 Participants
|
|
Smoking Classification
Ex-Smoker
|
7 Participants
n=33 Participants
|
3 Participants
n=32 Participants
|
10 Participants
n=65 Participants
|
|
Birth Experience
Had Birth Experience
|
12 Participants
n=33 Participants
|
12 Participants
n=32 Participants
|
24 Participants
n=65 Participants
|
|
Birth Experience
Had No Birth Experience
|
21 Participants
n=33 Participants
|
20 Participants
n=32 Participants
|
41 Participants
n=65 Participants
|
|
Type of Uterine Fibroid
Subserosal Fibroid
|
17 Participants
n=33 Participants
|
9 Participants
n=32 Participants
|
26 Participants
n=65 Participants
|
|
Type of Uterine Fibroid
Intramural Fibroid
|
22 Participants
n=33 Participants
|
29 Participants
n=32 Participants
|
51 Participants
n=65 Participants
|
|
Stopped Any Medications for Uterine Fibroids
Had Stopped Any Medications
|
5 Participants
n=33 Participants
|
7 Participants
n=32 Participants
|
12 Participants
n=65 Participants
|
|
Stopped Any Medications for Uterine Fibroids
Had not Stopped Any Medications
|
28 Participants
n=33 Participants
|
25 Participants
n=32 Participants
|
53 Participants
n=65 Participants
|
|
Number of Participants With No Surgery for Uterine Fibroids
|
33 Participants
n=33 Participants
|
32 Participants
n=32 Participants
|
65 Participants
n=65 Participants
|
|
Volume of Myoma
|
78.83 cm^3
STANDARD_DEVIATION 84.189 • n=33 Participants
|
101.38 cm^3
STANDARD_DEVIATION 172.738 • n=32 Participants
|
89.94 cm^3
STANDARD_DEVIATION 134.633 • n=65 Participants
|
|
Volume of Uterus
|
252.29 cm^3
STANDARD_DEVIATION 202.938 • n=33 Participants
|
300.09 cm^3
STANDARD_DEVIATION 295.341 • n=32 Participants
|
275.82 cm^3
STANDARD_DEVIATION 251.837 • n=65 Participants
|
|
Maximum Numerical Rating Scale (NRS) Score
|
6.64 score on a scale
STANDARD_DEVIATION 1.817 • n=33 Participants
|
6.28 score on a scale
STANDARD_DEVIATION 1.689 • n=32 Participants
|
6.46 score on a scale
STANDARD_DEVIATION 1.751 • n=65 Participants
|
|
Uterine Fibroid Symptom and Quality of Life (UFS-QOL) Score: Symptom Severity
|
25.5 score on a scale
STANDARD_DEVIATION 8.59 • n=33 Participants
|
30.3 score on a scale
STANDARD_DEVIATION 13.07 • n=32 Participants
|
27.9 score on a scale
STANDARD_DEVIATION 11.20 • n=65 Participants
|
|
UFS-QOL Score: Health Relate Quality of Life (HRQL) Total
|
83.9 score on a scale
STANDARD_DEVIATION 12.47 • n=33 Participants
|
80.0 score on a scale
STANDARD_DEVIATION 15.00 • n=32 Participants
|
82.0 score on a scale
STANDARD_DEVIATION 13.81 • n=65 Participants
|
PRIMARY outcome
Timeframe: For 28 days before the final dose of study drug (up to Week 12)Population: Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study drug for the treatment period.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Percentage of Participants With a Maximum NRS Score of 1 or Less During the 28 Days Before the Final Dose of Study Drug
|
57.6 percentage of participants
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: For 28 days before the final dose of study drug (up to Week 12)Population: FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Percentage of Participants With a Maximum NRS Score of 0 During the 28 Days Before the Final Dose of Study Drug
|
48.5 percentage of participants
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: For 28 days before the final dose of study drug (up to Week 12)Population: FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Mean NRS Score During the 28 Days Before the Final Dose of Study Drug
|
0.50 score on a scale
Standard Deviation 0.967
|
0.99 score on a scale
Standard Deviation 1.274
|
SECONDARY outcome
Timeframe: For 28 days before the final dose of study drug (up to Week 12)Population: FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Percentage of Days Without Pain Symptoms (NRS = 0) During the 28 Days Before the Final Dose of Study Drug
|
76.73 percentage of days
Standard Deviation 32.006
|
64.78 percentage of days
Standard Deviation 29.015
|
SECONDARY outcome
Timeframe: Day 1 to 28, Day 29 to 56, and Day 57 to 84Population: 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.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
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
Day 1 to 28
|
24.2 percentage of participants
|
0.0 percentage of participants
|
|
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
Day 29 to 56
|
45.5 percentage of participants
|
12.9 percentage of participants
|
|
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
Day 57 to 84
|
59.4 percentage of participants
|
12.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to 28, Day 29 to 56, and Day 57 to 84Population: 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.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
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
Day 1 to 28
|
15.2 percentage of participants
|
0.0 percentage of participants
|
|
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
Day 29 to 56
|
27.3 percentage of participants
|
6.5 percentage of participants
|
|
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
Day 57 to 84
|
46.9 percentage of participants
|
6.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to 28, Day 29 to 56, and Day 57 to 84Population: 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.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Mean NRS Score From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Day 1 to 28
|
1.26 score on a scale
Standard Deviation 1.490
|
1.17 score on a scale
Standard Deviation 1.141
|
|
Mean NRS Score From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Day 29 to 56
|
0.59 score on a scale
Standard Deviation 0.991
|
1.16 score on a scale
Standard Deviation 1.457
|
|
Mean NRS Score From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Day 57 to 84
|
0.43 score on a scale
Standard Deviation 0.776
|
0.97 score on a scale
Standard Deviation 1.279
|
SECONDARY outcome
Timeframe: Day 1 to 28, Day 29 to 56, and Day 57 to 84Population: 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.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Percentage of Days Without Pain Symptoms (NRS = 0) From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Day 57 to 84
|
77.43 percentage of days
Standard Deviation 30.854
|
65.84 percentage of days
Standard Deviation 29.224
|
|
Percentage of Days Without Pain Symptoms (NRS = 0) From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Day 29 to 56
|
73.98 percentage of days
Standard Deviation 31.718
|
61.29 percentage of days
Standard Deviation 31.459
|
|
Percentage of Days Without Pain Symptoms (NRS = 0) From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84
Day 1 to 28
|
60.49 percentage of days
Standard Deviation 34.043
|
56.32 percentage of days
Standard Deviation 28.891
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
|
29 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Values of Vital Signs
Diastolic Blood Pressure Lower (<50 mmHg)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values of Vital Signs
Body temperature Lower (<35.6 °C)
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to weight was reported.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Weight
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to ECG was reported.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Standard 12-lead Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.
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.
Outcome measures
| Measure |
Relugolix 40 mg
n=33 Participants
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.
|
Placebo
n=32 Participants
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.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Values of Laboratory Tests
Hemoglobin Lower (<0.8×LLN g/dL)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values of Laboratory Tests
WBC Upper (>1.5×ULN × 10^3cells/μL)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values of Laboratory Tests
Total Cholesterol Upper (>300 mg/dL)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Values of Laboratory Tests
Triglycerides Upper (>2.5×ULN mg/dL)
|
0 Participants
|
3 Participants
|
|
Number of Participants With Markedly Abnormal Values of Laboratory Tests
Total Bilirubin Upper (>2.0 mg/dL)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Values of Laboratory Tests
GGT Upper (>3×ULN U/L)
|
1 Participants
|
0 Participants
|
Adverse Events
Relugolix 40 mg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Relugolix 40 mg
n=33 participants at risk
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.
|
Placebo
n=32 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
21.2%
7/33 • Up to Week 16
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.
|
28.1%
9/32 • Up to Week 16
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.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
2/33 • Up to Week 16
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.
|
0.00%
0/32 • Up to Week 16
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.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
2/33 • Up to Week 16
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.
|
0.00%
0/32 • Up to Week 16
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/33 • Up to Week 16
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.
|
6.2%
2/32 • Up to Week 16
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.
|
|
Psychiatric disorders
Insomnia
|
9.1%
3/33 • Up to Week 16
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.
|
0.00%
0/32 • Up to Week 16
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.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
39.4%
13/33 • Up to Week 16
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.
|
9.4%
3/32 • Up to Week 16
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.
|
|
Reproductive system and breast disorders
Menorrhagia
|
12.1%
4/33 • Up to Week 16
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.
|
9.4%
3/32 • Up to Week 16
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.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
3.0%
1/33 • Up to Week 16
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.
|
9.4%
3/32 • Up to Week 16
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.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
6.1%
2/33 • Up to Week 16
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.
|
0.00%
0/32 • Up to Week 16
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • Up to Week 16
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.
|
6.2%
2/32 • Up to Week 16
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
2/33 • Up to Week 16
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.
|
0.00%
0/32 • Up to Week 16
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
15.2%
5/33 • Up to Week 16
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.
|
0.00%
0/32 • Up to Week 16
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.
|
|
Vascular disorders
Hot flush
|
45.5%
15/33 • Up to Week 16
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.
|
0.00%
0/32 • Up to Week 16
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER