Trial Outcomes & Findings for Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids (NCT NCT03751124)
NCT ID: NCT03751124
Last Updated: 2024-06-25
Results Overview
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 76 using the Kaplan-Meier method.
COMPLETED
PHASE3
229 participants
Week 52/Baseline up to Week 76
2024-06-25
Participant Flow
Participants who completed the long-term extension study with a response to treatment, signed the informed consent form, and met all eligibility criteria were enrolled in the study.
One participant in the placebo group was randomized in error and did not receive treatment, therefore, not included in the modified intent-to-treat (mITT) population.
Participant milestones
| Measure |
Relugolix Plus Estradiol (E2) /Norethindrone Acetate (NETA) (Group A)
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
114
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
115
|
113
|
|
Overall Study
COMPLETED
|
89
|
86
|
|
Overall Study
NOT COMPLETED
|
26
|
28
|
Reasons for withdrawal
| Measure |
Relugolix Plus Estradiol (E2) /Norethindrone Acetate (NETA) (Group A)
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Other
|
9
|
9
|
|
Overall Study
Participants who did not receive any study drug
|
0
|
1
|
Baseline Characteristics
The data was reported for participants analyzed for each parameter.
Baseline characteristics by cohort
| Measure |
Relugolix Plus E2/NETA (Group A)
n=115 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=113 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 5.58 • n=115 Participants
|
44.2 years
STANDARD_DEVIATION 4.39 • n=113 Participants
|
43.8 years
STANDARD_DEVIATION 5.04 • n=228 Participants
|
|
Sex/Gender, Customized
Female
|
115 Participants
n=115 Participants
|
113 Participants
n=113 Participants
|
228 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=115 Participants
|
29 Participants
n=113 Participants
|
58 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=115 Participants
|
84 Participants
n=113 Participants
|
169 Participants
n=228 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=115 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=115 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=115 Participants
|
1 Participants
n=113 Participants
|
2 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
49 Participants
n=115 Participants
|
57 Participants
n=113 Participants
|
106 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=115 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=115 Participants
|
52 Participants
n=113 Participants
|
115 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=115 Participants
|
2 Participants
n=113 Participants
|
3 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=115 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=228 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=115 Participants
|
1 Participants
n=113 Participants
|
1 Participants
n=228 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=115 Participants
|
8 participants
n=113 Participants
|
12 participants
n=228 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=115 Participants
|
74 participants
n=113 Participants
|
148 participants
n=228 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=115 Participants
|
1 participants
n=113 Participants
|
3 participants
n=228 Participants
|
|
Region of Enrollment
Brazil
|
5 participants
n=115 Participants
|
2 participants
n=113 Participants
|
7 participants
n=228 Participants
|
|
Region of Enrollment
Poland
|
14 participants
n=115 Participants
|
12 participants
n=113 Participants
|
26 participants
n=228 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=115 Participants
|
3 participants
n=113 Participants
|
9 participants
n=228 Participants
|
|
Region of Enrollment
South Africa
|
7 participants
n=115 Participants
|
6 participants
n=113 Participants
|
13 participants
n=228 Participants
|
|
Region of Enrollment
Chile
|
3 participants
n=115 Participants
|
8 participants
n=113 Participants
|
11 participants
n=228 Participants
|
|
Bone Mineral Density (BMD) at Week 52/Baseline
Lumbar Spine (L1-L4)
|
1.18 g/cm^2
STANDARD_DEVIATION 0.173 • n=111 Participants • The data was reported for participants analyzed for each parameter.
|
1.20 g/cm^2
STANDARD_DEVIATION 0.147 • n=112 Participants • The data was reported for participants analyzed for each parameter.
|
1.19 g/cm^2
STANDARD_DEVIATION 0.160 • n=223 Participants • The data was reported for participants analyzed for each parameter.
|
|
Bone Mineral Density (BMD) at Week 52/Baseline
Total hip
|
1.04 g/cm^2
STANDARD_DEVIATION 0.151 • n=111 Participants • The data was reported for participants analyzed for each parameter.
|
1.04 g/cm^2
STANDARD_DEVIATION 0.140 • n=110 Participants • The data was reported for participants analyzed for each parameter.
|
1.04 g/cm^2
STANDARD_DEVIATION 0.145 • n=221 Participants • The data was reported for participants analyzed for each parameter.
|
|
Bone Mineral Density (BMD) at Week 52/Baseline
Femoral neck
|
0.97 g/cm^2
STANDARD_DEVIATION 0.186 • n=111 Participants • The data was reported for participants analyzed for each parameter.
|
0.97 g/cm^2
STANDARD_DEVIATION 0.164 • n=110 Participants • The data was reported for participants analyzed for each parameter.
|
0.97 g/cm^2
STANDARD_DEVIATION 0.175 • n=221 Participants • The data was reported for participants analyzed for each parameter.
|
|
Mean Menstrual Blood Loss (MBL) Volume at Week 52/ Baseline
|
8.67 mL
STANDARD_DEVIATION 30.943 • n=115 Participants
|
6.40 mL
STANDARD_DEVIATION 20.073 • n=113 Participants
|
7.55 mL
STANDARD_DEVIATION 26.095 • n=228 Participants
|
|
Hemoglobin at Week 52/Baseline
|
13.00 g/dL
STANDARD_DEVIATION 1.405 • n=115 Participants
|
12.81 g/dL
STANDARD_DEVIATION 1.305 • n=113 Participants
|
12.91 g/dL
STANDARD_DEVIATION 1.356 • n=228 Participants
|
|
Index uterine fibroid volume at Week 52/Baseline
|
40.06 cm^3
STANDARD_DEVIATION 59.093 • n=115 Participants • The data was reported for participants analyzed for each parameter
|
70.36 cm^3
STANDARD_DEVIATION 142.863 • n=112 Participants • The data was reported for participants analyzed for each parameter
|
55.01 cm^3
STANDARD_DEVIATION 109.619 • n=227 Participants • The data was reported for participants analyzed for each parameter
|
|
Uterine Volume at Week 52/Baseline
|
274.95 cm^3
STANDARD_DEVIATION 201.122 • n=115 Participants
|
324.98 cm^3
STANDARD_DEVIATION 309.228 • n=113 Participants
|
299.75 cm^3
STANDARD_DEVIATION 261.001 • n=228 Participants
|
|
UFS-QoL Bleeding and Pelvic Discomfort (BPD) Scale Score at Week 52/Baseline
|
10.51 score on a scale
STANDARD_DEVIATION 17.138 • n=115 Participants
|
15.12 score on a scale
STANDARD_DEVIATION 24.027 • n=113 Participants
|
12.79 score on a scale
STANDARD_DEVIATION 20.921 • n=228 Participants
|
|
UFS-QoL Symptom Severity Score at Week 52/Baseline
|
14.62 score on a scale
STANDARD_DEVIATION 18.346 • n=115 Participants
|
18.36 score on a scale
STANDARD_DEVIATION 22.659 • n=113 Participants
|
16.47 score on a scale
STANDARD_DEVIATION 20.636 • n=228 Participants
|
|
Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Total Score at Week 52/Baseline
|
86.07 scores on a scale
STANDARD_DEVIATION 18.566 • n=115 Participants
|
81.06 scores on a scale
STANDARD_DEVIATION 21.971 • n=113 Participants
|
83.59 scores on a scale
STANDARD_DEVIATION 20.435 • n=228 Participants
|
|
Patient Global Assessment (PGA) for uterine fibroid-related function at Week 52/Baseline
No limitation at all
|
94 Participants
n=115 Participants
|
94 Participants
n=113 Participants
|
188 Participants
n=228 Participants
|
|
Patient Global Assessment (PGA) for uterine fibroid-related function at Week 52/Baseline
Mild limitation
|
12 Participants
n=115 Participants
|
10 Participants
n=113 Participants
|
22 Participants
n=228 Participants
|
|
Patient Global Assessment (PGA) for uterine fibroid-related function at Week 52/Baseline
Moderate limitation
|
4 Participants
n=115 Participants
|
5 Participants
n=113 Participants
|
9 Participants
n=228 Participants
|
|
Patient Global Assessment (PGA) for uterine fibroid-related function at Week 52/Baseline
Quite a bit of limitation
|
2 Participants
n=115 Participants
|
2 Participants
n=113 Participants
|
4 Participants
n=228 Participants
|
|
Patient Global Assessment (PGA) for uterine fibroid-related function at Week 52/Baseline
Extreme limitation
|
3 Participants
n=115 Participants
|
2 Participants
n=113 Participants
|
5 Participants
n=228 Participants
|
|
PGA for uterine fibroid-related symptom at Week 52/Baseline
Not severe
|
99 Participants
n=115 Participants
|
97 Participants
n=113 Participants
|
196 Participants
n=228 Participants
|
|
PGA for uterine fibroid-related symptom at Week 52/Baseline
Mildly severe
|
6 Participants
n=115 Participants
|
7 Participants
n=113 Participants
|
13 Participants
n=228 Participants
|
|
PGA for uterine fibroid-related symptom at Week 52/Baseline
Moderately severe
|
6 Participants
n=115 Participants
|
4 Participants
n=113 Participants
|
10 Participants
n=228 Participants
|
|
PGA for uterine fibroid-related symptom at Week 52/Baseline
Very severe
|
2 Participants
n=115 Participants
|
2 Participants
n=113 Participants
|
4 Participants
n=228 Participants
|
|
PGA for uterine fibroid-related symptom at Week 52/Baseline
Extremely severe
|
2 Participants
n=115 Participants
|
3 Participants
n=113 Participants
|
5 Participants
n=228 Participants
|
PRIMARY outcome
Timeframe: Week 52/Baseline up to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 76 using the Kaplan-Meier method.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=115 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=113 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period
|
78.43 percentage of participants
Interval 69.33 to 85.12
|
15.08 percentage of participants
Interval 8.91 to 22.76
|
SECONDARY outcome
Timeframe: From Week 52/Baseline through Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=115 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=113 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Time To MBL Volume ≥80 mL During The Randomized Treatment Period
|
NA weeks
Median time to relapse was not reached due to the small number of participants with events (fewer than 50% of participants relapsed)
|
5.9 weeks
Interval 5.4 to 6.3
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 104 using the Kaplan-Meier method.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=115 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=113 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Who Maintained MBL Volume Of <80 mL At Week 104 During The Randomized Treatment Period
|
69.79 percentage of participants
Interval 59.72 to 77.8
|
11.75 percentage of participants
Interval 6.32 to 19.0
|
SECONDARY outcome
Timeframe: Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA and placebo).
Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=115 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=113 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 76 During The Randomized Treatment Period
|
57.39 percentage of participants
Interval 47.83 to 66.56
|
13.27 percentage of participants
Interval 7.62 to 20.95
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=81 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=17 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period
|
6.6 mL
Standard Deviation 42.80
|
11.5 mL
Standard Deviation 27.45
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=63 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period
|
2.1 mL
Standard Deviation 28.85
|
3.9 mL
Standard Deviation 10.92
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all randomized participants who had taken at least 1 dose of study treatment. The % change from Week 52 in MBL volume was only available when Week 52 MBL volume is \> 0 mL and post-Week 52 MBL volumes were available. The majority of mITT participants had MBL volume of 0 mL at Week 52/Baseline (92/115 in Group A and 89/113 in Group B). Number analyzed represents proportion of mITT population with MBL volume \> 0 mL at Week 52 and values at each time point.
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=14 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=2 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period
|
652.0 percent change
Standard Deviation 1759.37
|
55.0 percent change
Standard Deviation 219.15
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all randomized participants who had taken at least 1 dose of study treatment. The % change from Week 52 in MBL volume was only available when Week 52 MBL volume is \> 0 mL and post-Week 52 MBL volumes were available. The majority of mITT participants had MBL volume of 0 mL at Week 52/Baseline (92/115 in Group A and 89/113 in Group B). Number analyzed represents proportion of mITT population with MBL volume \> 0 mL at Week 52 and values at each time point.
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. Participants with amenorrhea are assigned with an MBL value of 0 mL and participants with spotting are assigned with an MBL value of 4.99 mL. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=8 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period
|
-42.0 percent change
Standard Deviation 48.80
|
—
|
SECONDARY outcome
Timeframe: Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
Assessed using participant daily diary and MBL volume measured using the alkaline hematin method. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea or no feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=115 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=113 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 104 During The Randomized Treatment Period
|
58.26 percentage of patients
Interval 48.7 to 67.39
|
10.62 percentage of patients
Interval 5.61 to 17.82
|
SECONDARY outcome
Timeframe: From Initiation of Retreatment to Week 104Population: Retreatment population: comprised participants in the mITT population from both treatment groups whose MBL volume reached ≥ 80 mL during the randomized treatment period and who started retreatment.
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=26 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=89 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Who Responded (MBL Volume <80 mL) To Retreatment During The Retreatment Period
|
96.15 percentage of participants
Interval 80.36 to 99.9
|
97.75 percentage of participants
Interval 92.12 to 99.73
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76 and Week 104Population: mITT population who was amenorrhoeic at Week 52/Baseline: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo) and who were amenorrhoeic at Week 52/Baseline.
Participants who were previously amenorrhoeic were deemed to resume menses according to the following rules: MBL volume of collected feminine product was ≥5 mL; MBL volume of collected feminine product was \<5 mL; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; no feminine products were returned because the participant failed to collect used products per protocol; however, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit; or no feminine products were returned due to other reasons that indicated menstruation had occurred; also, there were more than 5 days and more than 3 consecutive days of bleeding with feminine product use during the visit.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=92 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=89 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Whose Menses Had Resumed During The Randomized Treatment Period
Week 76
|
35.29 percentage of participants
Interval 26.14 to 46.48
|
91.54 percentage of participants
Interval 84.33 to 96.28
|
|
Percentage Of Participants Whose Menses Had Resumed During The Randomized Treatment Period
Week 104
|
41.12 percentage of participants
Interval 31.22 to 52.75
|
92.75 percentage of participants
Interval 85.86 to 97.04
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 104Population: mITT population who was amenorrhoeic at Week 52/Baseline: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo) and who were amenorrhoeic at Week 52/Baseline.
Assessed using participant daily diary. Participants were deemed to be amenorrhoeic if one of the following criteria was met: No feminine products returned due to reported amenorrhea, or No feminine products returned due to reported spotting or feminine product collection with a negligible observed MBL volume (\<5 mL) coupled with other data indicating infrequent non-cyclic bleeding/spotting. If no feminine product collection because participant failed to collect used products per protocol or due to "Other" reason, the amenorrhea status was set to missing. Missing responses for menstrual bleeding questions in the paper diary were treated as "No Bleeding" if paper diary entry/compliance rate was \>70%.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=92 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=89 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Time To Resumption Of Menses For Participants Who Were Amenorrhoeic At Week 52/Baseline During The Randomized Treatment Period
|
NA weeks
Interval 42.6 to
Median time to menses resumption was not reached as \<50% of participants did not resume menses within the 52-week randomized treatment period.
|
5.4 weeks
Interval 5.0 to 5.9
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=81 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=20 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
|
0.3 g/dL
Standard Deviation 0.96
|
-0.1 g/dL
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=59 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
|
0.3 g/dL
Standard Deviation 1.03
|
-0.2 g/dL
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: From Week 52/Baseline to Week 76 and Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=115 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=113 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants With MBL Volume Of ≥80 mL At Week 76 And Week 104 During the Randomized Treatment Period
At Week 76
|
21.57 percentage of participants
Interval 14.88 to 30.67
|
84.92 percentage of participants
Interval 77.24 to 91.09
|
|
Percentage Of Participants With MBL Volume Of ≥80 mL At Week 76 And Week 104 During the Randomized Treatment Period
At Week 104
|
30.21 percentage of participants
Interval 22.2 to 40.28
|
88.25 percentage of participants
Interval 81.0 to 93.68
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 64Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=97 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=72 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
|
1.3 percent change
Standard Deviation 6.75
|
-4.3 percent change
Standard Deviation 8.53
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=81 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=20 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
|
2.8 percent change
Standard Deviation 8.30
|
-0.8 percent change
Standard Deviation 9.10
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=59 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percent Change From Week 52/Baseline In Hemoglobin Concentration During The Randomized Treatment Period
|
2.3 percent change
Standard Deviation 8.94
|
-0.7 percent change
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=81 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=20 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Who Had Hemoglobin Level ≤10.5 g/dL Over Time During The Randomized Treatment Period
|
4.94 percentage of participants
Interval 1.36 to 12.16
|
10.00 percentage of participants
Interval 1.23 to 31.7
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=59 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Who Had Hemoglobin Level ≤10.5 g/dL Over Time During The Randomized Treatment Period
|
5.08 percentage of participants
Interval 1.06 to 14.15
|
0 percentage of participants
Interval 0.0 to 36.94
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=81 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=20 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Who Had Hemoglobin Level <11.6 g/dL Over Time During The Randomized Treatment Period
|
6.17 percentage of participants
Interval 2.03 to 13.82
|
15.00 percentage of participants
Interval 3.21 to 37.89
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for hemoglobin measurements in accordance with the specified time points.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=59 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percentage Of Participants Who Had Hemoglobin Level <11.6 g/dL Over Time During The Randomized Treatment Period
|
6.78 percentage of participants
Interval 1.88 to 16.46
|
25.00 percentage of participants
Interval 3.19 to 65.09
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=85 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=21 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Mental Health
|
0.5 score on a scale
Standard Deviation 8.30
|
-1.0 score on a scale
Standard Deviation 9.98
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Physical Functioning
|
1.1 score on a scale
Standard Deviation 4.24
|
-2.3 score on a scale
Standard Deviation 5.16
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Role-Physical
|
0.3 score on a scale
Standard Deviation 4.80
|
-1.2 score on a scale
Standard Deviation 4.75
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Bodily Pain
|
0.6 score on a scale
Standard Deviation 8.02
|
-0.3 score on a scale
Standard Deviation 9.78
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
General Health
|
0 score on a scale
Standard Deviation 6.68
|
-3.1 score on a scale
Standard Deviation 6.81
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Vitality
|
0.5 score on a scale
Standard Deviation 7.87
|
0.4 score on a scale
Standard Deviation 8.83
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Social Functioning
|
-0.2 score on a scale
Standard Deviation 7.85
|
-2.9 score on a scale
Standard Deviation 6.65
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Role-Emotional
|
0.6 score on a scale
Standard Deviation 7.38
|
-1.0 score on a scale
Standard Deviation 7.23
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=64 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Physical Functioning
|
0.5 score on a scale
Standard Deviation 5.44
|
0.5 score on a scale
Standard Deviation 2.23
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Role-Physical
|
-0.5 score on a scale
Standard Deviation 6.49
|
-0.6 score on a scale
Standard Deviation 2.88
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Bodily Pain
|
1.9 score on a scale
Standard Deviation 7.36
|
1.7 score on a scale
Standard Deviation 8.42
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
General Health
|
-0.6 score on a scale
Standard Deviation 5.67
|
-5.5 score on a scale
Standard Deviation 7.72
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Vitality
|
0.5 score on a scale
Standard Deviation 7.53
|
3.0 score on a scale
Standard Deviation 8.84
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Social Functioning
|
-0.4 score on a scale
Standard Deviation 7.85
|
-0.6 score on a scale
Standard Deviation 3.21
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Role-Emotional
|
-0.2 score on a scale
Standard Deviation 7.32
|
-3.9 score on a scale
Standard Deviation 6.29
|
|
Change From Week 52/Baseline In Short Form 36v2 (SF-36v2) Domain During The Randomized Treatment Period
Mental Health
|
-0.8 score on a scale
Standard Deviation 7.34
|
2.9 score on a scale
Standard Deviation 9.83
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary (MCS) score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=85 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=21 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In SF-36v2 Summary Component Scores During The Randomized Treatment Period
PCS
|
0.6 score on a scale
Standard Deviation 4.89
|
-1.8 score on a scale
Standard Deviation 6.00
|
|
Change From Week 52/Baseline In SF-36v2 Summary Component Scores During The Randomized Treatment Period
MCS
|
0.2 score on a scale
Standard Deviation 7.93
|
-0.8 score on a scale
Standard Deviation 7.70
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
The Short-Form Health Survey Standard (SF-36) is a validated, 36-item questionnaire, assessing general overall quality of life and was completed by participants on paper before other study procedures were performed, except for at the Week 52/Baseline visit, which was completed after eligibility for this study was confirmed and all Week 52 procedures for the long-term extension study were completed. Scores are calculated for each domain and 2 summary scores - a physical component summary (PCS) score (Domains \[number of items\]: Physical Functioning \[10\], Role-Physical \[4\], Bodily Pain \[2\], General Health \[5\]), a mental component summary (MCS) score (Domains \[number of items\]: Vitality \[4\], Social Functioning \[2\], Role-Emotional \[3\], and Mental Health \[5\]), and reported Health Transition \[1\]. Individual domain and component summary scores range from 0 to 100. Higher scores indicate higher health-related quality of life.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=63 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In SF-36v2 Summary Component Scores During The Randomized Treatment Period
PCS
|
0.8 score on a scale
Standard Deviation 5.18
|
-0.6 score on a scale
Standard Deviation 4.04
|
|
Change From Week 52/Baseline In SF-36v2 Summary Component Scores During The Randomized Treatment Period
MCS
|
-0.8 score on a scale
Standard Deviation 6.65
|
0.1 score on a scale
Standard Deviation 7.71
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=86 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=21 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
4 Category deterioration
|
0 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
3 Category deterioration
|
2 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
2 Category deterioration
|
4 Participants
|
3 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
1 Category deterioration
|
8 Participants
|
3 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
No change
|
63 Participants
|
14 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
1 Category improvement
|
5 Participants
|
1 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
2 Category improvement
|
2 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
3 Category improvement
|
1 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
4 Category improvement
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
The PGA for function is a 1-item questionnaire designed to assess participant's impression of the impact on their function related to uterine fibroids affected their usual activities and was completed on paper. The PGA for function was evaluated using a 5-point Likert scale (1 = No limitation at all; 5 = Extreme limitation) with higher numbers representing worse results. Endpoint values represent the worsening of function (deterioration), improvement of function (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (No limitation at all) to 5 (Extreme limitation) and a 4-category improvement represents a change from 5 (Extreme limitation) to 1 (No limitation at all).
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=65 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
3 Category deterioration
|
0 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
No change
|
54 Participants
|
7 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
4 Category deterioration
|
0 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
2 Category deterioration
|
3 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
1 Category deterioration
|
4 Participants
|
1 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
1 Category improvement
|
2 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
2 Category improvement
|
1 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
3 Category improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Function During The Randomized Treatment Period
4 Category improvement
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=86 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=21 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
4 Category deterioration
|
0 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
3 Category deterioration
|
1 Participants
|
1 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
2 Category deterioration
|
4 Participants
|
3 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
1 Category deterioration
|
8 Participants
|
3 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
No change
|
63 Participants
|
13 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
1 Category improvement
|
5 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
2 Category improvement
|
4 Participants
|
1 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
3 Category improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
4 Category improvement
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids and was completed on paper. The PGA for symptoms was evaluated using a 5-point Likert scale (1 = Not severe; 5 = Extremely severe) with higher numbers representing worse results. Endpoint values represent the worsening of symptoms (deterioration), improvement of symptoms (improvement), or no change by category at each time point. For example, a 4-category deterioration represents a change from 1 (Not severe) to 5 (Extremely severe) and a 4-category improvement represents a change from 5 (Extremely severe) to 1 (Not severe).
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=65 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
No change
|
58 Participants
|
7 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
4 Category deterioration
|
0 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
3 Category deterioration
|
1 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
2 Category deterioration
|
1 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
1 Category deterioration
|
0 Participants
|
1 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
1 Category improvement
|
2 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
2 Category improvement
|
2 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
3 Category improvement
|
0 Participants
|
0 Participants
|
|
Categorical Change From Week 52/Baseline In PGA For Uterine Fibroid-related Symptoms During The Randomized Treatment Period
4 Category improvement
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=62 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=13 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Work Time Missed Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
|
0.7 percentage score
Standard Deviation 10.22
|
3.9 percentage score
Standard Deviation 13.85
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent work time missed due to uterine fibroids was calculated from hours missed due to uterine fibroids divided by the sum of hours missed due to uterine fibroids plus hours actually worked. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=48 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=5 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Work Time Missed Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
|
0.5 percentage score
Standard Deviation 8.50
|
0 percentage score
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=70 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=17 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Impairment While Working Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
|
-1.1 percentage score
Standard Deviation 16.20
|
1.8 percentage score
Standard Deviation 15.90
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent impairment while working due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=54 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=6 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Impairment While Working Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
|
0 percentage score
Standard Deviation 15.17
|
5.0 percentage score
Standard Deviation 12.25
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=62 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=13 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Overall Work Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
|
-0.8 percentage score
Standard Deviation 20.05
|
3.2 percentage score
Standard Deviation 10.56
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent overall work impairment due to uterine fibroid symptoms was calculated from the work time missed due to uterine fibroids plus the value calculated from 1 minus the work time missed value multiplied by the value for impairment while working due to uterine fibroids. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=48 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=5 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Overall Work Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
|
0.6 percentage score
Standard Deviation 19.13
|
6.0 percentage score
Standard Deviation 13.42
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented activity) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=85 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=20 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Activity Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
|
-0.5 percentage score
Standard Deviation 21.10
|
4.5 percentage score
Standard Deviation 19.32
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo).
The WPAI-UF is a validated instrument used to measure self-reported absenteeism, presenteeism, and daily activity impairment attributed to uterine fibroids. The WPAI-UF was to be completed on a paper questionnaire and participants were to answer these questions. Percent activity impairment due to uterine fibroid symptoms was calculated by taking the reported value from 1 (no effect) to 10 (completely prevented work) and dividing by 10. This value was then multiplied by 100 to get a percentage. The WPAI-UF outcomes are expressed as impairment percentages (0 to 100%), with higher numbers indicating greater impairment and less productivity due to uterine fibroids, that is, worse outcomes.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=64 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The Work Productivity Activity Impairment - Percent Activity Impairment Due to Uterine Fibroids (WPAI-UF) Scores During The Randomized Treatment Period
|
-1.3 percentage score
Standard Deviation 18.90
|
5.0 percentage score
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=86 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=21 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Score During The Randomized Treatment Period
|
3.4 score on a scale
Standard Deviation 20.27
|
17.5 score on a scale
Standard Deviation 24.99
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Assessed using the UFS-QOL which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer the following questions: heavy bleeding during your menstrual period (Question 1), passing blood clots during your menstrual period (Question 2), and feeling tightness or pressure in your pelvic area (Question 5). Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1, 2, and 5 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater distress and a lower score of less distress (high scores = bad).
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=65 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The UFS-QoL Bleeding And Pelvic Discomfort Score During The Randomized Treatment Period
|
-0.5 score on a scale
Standard Deviation 17.85
|
-6.3 score on a scale
Standard Deviation 43.36
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=86 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=21 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Original: Change From Week 52/Baseline In The UFS-QoL Symptom Severity Score During The Randomized Treatment Period
|
2.2 score on a scale
Standard Deviation 18.16
|
14.1 score on a scale
Standard Deviation 21.07
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values at that time point.
Assessed using the UFS-QOL, which is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Items are scored on a 5-point scale, ranging from "not at all" to "a very great deal." A summed score was created for questions 1 through 8 and transformed to a normalized score with a range of possible values from 0 to 100, where a higher score was indicative of greater symptom severity and a lower score of lower symptom severity (negative score = improvement).
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=65 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
New: Change From Week 52/Baseline In The UFS-QoL Symptom Severity Score During The Randomized Treatment Period
|
0.1 score on a scale
Standard Deviation 15.94
|
-4.3 score on a scale
Standard Deviation 42.22
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 76Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=86 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=21 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Concern
|
-2.4 score on a scale
Standard Deviation 24.38
|
-13.6 score on a scale
Standard Deviation 27.76
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Total Score
|
-0.8 score on a scale
Standard Deviation 16.79
|
-9.1 score on a scale
Standard Deviation 22.37
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Activities
|
-1.7 score on a scale
Standard Deviation 17.46
|
-11.7 score on a scale
Standard Deviation 26.10
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Revised activities
|
-2.3 score on a scale
Standard Deviation 18.66
|
-13.3 score on a scale
Standard Deviation 27.13
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Energy/mood
|
-0.1 score on a scale
Standard Deviation 17.30
|
-3.9 score on a scale
Standard Deviation 23.69
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Control
|
0.2 score on a scale
Standard Deviation 15.60
|
-3.6 score on a scale
Standard Deviation 23.03
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Self-conscious
|
0 score on a scale
Standard Deviation 21.66
|
-11.5 score on a scale
Standard Deviation 16.77
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Sexual function
|
1.0 score on a scale
Standard Deviation 28.77
|
-16.7 score on a scale
Standard Deviation 43.72
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: mITT population: all participants randomized to treatment who had taken at least 1 dose of study treatment (relugolix plus E2/NETA or placebo). Number analyzed represents proportion of overall group with values for that measure at that time point.
Assessed using the UFS-QOL which, is a validated instrument used to evaluate symptom severity and quality of life in participants with uterine fibroids. Items are scored on a 5-point scale, ranging from "none of the time" to "all of the time." The UFS-QoL was completed on a paper questionnaire and participants were to answer these questions. Questions 9 through 37 were used to calculate the total scores and the following subscales: concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function. All raw scores are transformed to normalized scores with a range of possible values from 0 to 100. A positive score indicates improvement.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=65 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=8 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Energy/mood
|
1.6 score on a scale
Standard Deviation 17.41
|
8.0 score on a scale
Standard Deviation 44.35
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Control
|
1.7 score on a scale
Standard Deviation 15.19
|
9.4 score on a scale
Standard Deviation 39.05
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Activities
|
0.9 score on a scale
Standard Deviation 16.74
|
8.5 score on a scale
Standard Deviation 42.00
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Concern
|
2.2 score on a scale
Standard Deviation 21.45
|
11.9 score on a scale
Standard Deviation 41.40
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Revised activities
|
0.6 score on a scale
Standard Deviation 16.02
|
7.5 score on a scale
Standard Deviation 42.59
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Self-conscious
|
-2.8 score on a scale
Standard Deviation 19.94
|
3.1 score on a scale
Standard Deviation 44.53
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Sexual function
|
0.8 score on a scale
Standard Deviation 26.51
|
3.1 score on a scale
Standard Deviation 52.08
|
|
Change From Week 52/Baseline In The UFS-QoL Score by Health-Related Quality Of Life Subscale And Total Scores During The Randomized Treatment Period
Total Score
|
1.1 score on a scale
Standard Deviation 15.25
|
8.2 score on a scale
Standard Deviation 42.12
|
SECONDARY outcome
Timeframe: Week 52/Baseline and Week 56Population: Safety population: all randomized participants who received at least 1 dose of study treatment. Overall number of participants analyzed represents proportion of overall group with values at that time point.
Blood samples were collected from participants for estradiol measurements and were analyzed using a standard clinical methodology. The change from Week 52/Baseline in estradiol concentration at Week 56 was presented in this outcome.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=88 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=75 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Predose Concentration Of Estradiol At Week 56
|
2.03 pg/mL
Standard Deviation 31.605
|
62.54 pg/mL
Standard Deviation 77.661
|
SECONDARY outcome
Timeframe: Week 52/Baseline up to Week 104Population: Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
Assessed by percentage of participants with AEs and serious AEs (SAEs). An AE was defined as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or a congenital anomaly/birth defect. Events of heavy menstrual bleeding were only reported if the event met criteria as an SAE. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=116 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=112 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Grade 3 or higher related to study drug
|
0 Participants
|
2 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Any AEs
|
68 Participants
|
72 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Leading to study treatment discontinuation
|
2 Participants
|
3 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Leading to study treatment interruption
|
1 Participants
|
0 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Related to study drug
|
26 Participants
|
27 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Grade 3 or higher
|
3 Participants
|
5 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
SAEs
|
2 Participants
|
2 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Serious and related to study drug
|
0 Participants
|
1 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Serious and leading to treatment discontinuation
|
1 Participants
|
1 Participants
|
|
Participants With Adverse Events (AEs) As A Measure Of Safety And Tolerability
Fatal outcome
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: Safety population: all randomized participants who received at least 1 dose of study treatment. Note: 1 patient was randomized to placebo and inadvertently dispensed open-label study drug; the patient took 1 dose and was considered part of Group A in the Safety population only and is represented in the Overall Number of Participants Analyzed. Number analyzed by location/group represents proportion of the Safety population with values for that measure at that time point.
Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4), total hip \[presented separately\], and femoral neck (same leg within each participant) \[presented separately\] at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=79 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=79 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percent Change From Week 52/Baseline In BMD At Lumbar Spine (L1-L4)
|
0.81 percent change
Interval 0.2 to 1.41
|
0.10 percent change
Interval -0.52 to 0.71
|
SECONDARY outcome
Timeframe: Week 52/Baseline to Week 104Population: Safety population: all randomized participants who received at least 1 dose of study treatment. Note: 1 patient was randomized to placebo and inadvertently dispensed open-label study drug; the patient took 1 dose and was considered part of Group A in the Safety population only and is represented in the Overall Number of Participants Analyzed. Number analyzed by location/group represents proportion of the Safety population with values for that measure at that time point.
Assessed by dual-energy X-ray absorptiometry scan at the lumbar spine (L1-L4) \[presented separately\], total hip, and femoral neck (same leg within each participant) at each designated timepoints. The least squares means and their 95% CI were based on analysis of covariance model with treatment, stratification factors, race as fixed factors, and age at Week 52/Baseline, Week 52/Baseline BMD value, and body mass index at Week 52/Baseline as covariates.
Outcome measures
| Measure |
Relugolix Plus E2/NETA (Group A)
n=79 Participants
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=77 Participants
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Percent Change From Week 52/Baseline In BMD At Femoral Neck And Total Hip
Total Hip
|
0.34 percent change
Interval -0.25 to 0.93
|
-0.13 percent change
Interval -0.73 to 0.47
|
|
Percent Change From Week 52/Baseline In BMD At Femoral Neck And Total Hip
Femoral Neck
|
-0.19 percent change
Interval -1.14 to 0.77
|
-0.76 percent change
Interval -1.74 to 0.21
|
Adverse Events
Relugolix Plus E2/NETA (Group A)
Placebo (Group B)
Serious adverse events
| Measure |
Relugolix Plus E2/NETA (Group A)
n=116 participants at risk
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=112 participants at risk
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.86%
1/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
0.00%
0/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.86%
1/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
0.00%
0/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxoid liposarcoma
|
0.00%
0/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
0.89%
1/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
0.89%
1/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
Other adverse events
| Measure |
Relugolix Plus E2/NETA (Group A)
n=116 participants at risk
Relugolix 40 mg co-administered with E2 (1 mg) and NETA (0.5 mg) for up to 52 weeks.
|
Placebo (Group B)
n=112 participants at risk
Relugolix placebo co-administered with E2 and NETA placebo for up to 52 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.2%
13/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
10.7%
12/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
|
Nervous system disorders
Headache
|
6.9%
8/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
4.5%
5/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.7%
2/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
7.1%
8/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
|
Vascular disorders
Hot flush
|
1.7%
2/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
7.1%
8/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
|
Vascular disorders
Hypertension
|
1.7%
2/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
5.4%
6/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/116 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
5.4%
6/112 • Week 52/Baseline up to Week 104
Safety population: all randomized participants who received at least 1 dose of study treatment. Note: One patient who was randomized to the placebo group was inadvertently dispensed open-label study drug of which the patient took 1 dose of relugolix + E2/NETA. Thus, the patient was considered as part of the relugolix + E2/NETA group in the Safety Population only. This changes the Group A population from 115 (mITT population) to 116 and the Group B population from 113 (mITT population) to 112.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place