Prostate Cancer
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (\<50 ng/dL).
Detailed description
The drug being tested in this study is called relugolix (TAK-385). Relugolix is being tested to treat people who have prostate cancer. This study will look at achieving and maintaining testosterone suppression (\<50 ng/dL). The study enrolled 136 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Relugolix 80 mg * Relugolix 120 mg * Leuprorelin 22.5 mg Relugolix was administered starting with a 320 mg (loading dose), followed by relugolix 80 mg or 120 mg tablets, for 48 weeks plus an optional 48-week extension at the investigator's discretion. Patients randomized to leuprorelin were administered 22.5 mg subcutaneously on Day 1 and every 12 weeks for 4 injections. This multicenter trial was conducted in the United States and Canada. The overall time to participate in this study was 114.4 weeks. Participants made multiple visits to the clinic and at 12 weeks after last dose of study drug for a follow-up assessment.
Interventions
DRUGRelugolix
Relugolix tablets
DRUGLeuprorelin
Leuprorelin subcutaneous injection
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each participant must meet all of the following inclusion criteria to be enrolled in the study: 1. Male participant 18 years or older. 2. Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. 3. Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer with 1 of the following clinical disease states: 1) advanced localized disease not suitable for primary therapy, 2) evidence of prostate-specific antigen (PSA) biochemical or clinical relapse following primary surgery or radiation therapy of curative intent, or 3) newly diagnosed metastatic disease that is asymptomatic or not threatening to vital organs. 4. Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol. 5. A body mass index (BMI) ≥ 18.0 at screening and/or baseline. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and/or baseline. 7. Male participants, even if surgically sterilized, who agree to practice effective barrier contraception or agree to practice true abstinence. 8. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. 9. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and pharmacodynamic (PD) Sampling.
Exclusion criteria
Participants meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Effective Castration Rate Over 24 Weeks | Day 1 of Week 5 to Day 1 of Week 25 | Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits beginning after 4 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With TEAEs Related to Physical Examination | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks | Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10) including slit lamp examination of the anterior eye. Any TEAEs Related to physical examination were reported. |
| Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks | A single 12-lead ECG was performed. ECGs were read and interpreted locally and reviewed if indicated by the study monitor. ECG abnormalities were reported as AEs. |
| Number of Participants With TEAES Related to Clinical Laboratory Test Results | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks | Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention. |
| Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any AE that results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. |
| Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | Week 5, Day 1 | PSA Response is defined as a reduction in PSA from Baseline and is reported for 2 categories: ≥ 50% reduction and ≥ 90% reduction. |
| Prostate-Specific Antigen Nadir | During Weeks 1 to 24 | PSA nadir is the lowest PSA achieved after treatment. |
| Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Day 1 of Weeks 13 and 25 | Blood was collected and serum concentrations of PSA were obtained using a validated laboratory test at a central laboratory facility. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks | Vital signs included oral temperature, pulse rate, supine systolic and diastolic blood pressure, standing systolic and diastolic blood pressure, and weight. Any TEAEs that were associated with vital signs were reported. |
| TAK-385 Plasma Concentrations | Day 1 of Weeks 1, 2, 3, 5, 9, 13, 17, 25, 37, 49 pre-dose; Day 4 of Week 1 pre-dose; Day 1 of Weeks 5, 13, 2 hrs post-dose | — |
| Serum Luteinizing Hormone (LH) Concentrations | Baseline and Day 4 of Week 1, Day 1 of Weeks 2, 3, 5,13, 25 and 49, End of Treatment (EOT - 106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) | Blood was collected and serum concentrations of LH in milli international units per milliliters (mIU/mL) were obtained using a validated laboratory test at a central laboratory facility. |
| Serum Follicle Stimulating Hormone (FSH) Concentrations | Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) | Blood was collected and serum concentrations of FSH were obtained using a validated laboratory test at a central laboratory facility. |
| Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) | Blood was collected and serum concentrations of SHBG were obtained using a validated laboratory test at a central laboratory facility. |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) | EORTC QLQ-PR25 is an EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer consisting of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions use are answered using a 4-point scale: 1=Not at all to 4 =Very much. All raw domain scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). A positive change from Baseline in activity or functioning scales and negative change from Baseline in symptom scales indicates improvement. |
| Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) | AMS scale is a self-administered questionnaire used to: 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between 1=none to 5=extremely severe for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms. |
| Change From Baseline in EORTC QLQ-C30 | Day 1 of Weeks 5, 13, 25, 37, 49, 73, 97, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks) | The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A positive change from Baseline in quality og life or functioning scales and negative change from Baseline in symptom or difficulties scales indicates improvement. |
| Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | During Weeks 1 to 24 | — |
Countries
Canada, United States
Participant flow
Recruitment details
Participants took part in the study at 23 investigative sites in Canada and the United States from 26 March 2014 to 23 February 2017.
Pre-assignment details
Participants with a diagnosis of prostate cancer were enrolled in 1 of 2 dose levels of TAK-385 (80 or 120 mg) or leuprorelin 22.5 mg.
Participants by arm
| Arm | Count |
|---|---|
| Relugolix 80 mg Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. | 56 |
| Relugolix 120 mg Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion. Bicalutamide is allowed for firs 4 weeks per investigator's discretion. | 54 |
| Leuprorelin 22.5 mg Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks). | 24 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 2 | 1 |
| Overall Study | Did not Receive Study Drug | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 3 | 0 |
| Overall Study | Reason not Specified | 9 | 6 | 5 |
| Overall Study | Study Terminated by Sponsor | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 15 | 1 |
Baseline characteristics
| Characteristic | Relugolix 80 mg | Relugolix 120 mg | Leuprorelin 22.5 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 72.3 years FULL_RANGE 9.25 | 72.1 years FULL_RANGE 8.06 | 68.3 years FULL_RANGE 6.77 | 70.9 years |
| Body Mass Index | 28.815 kg/m^2 FULL_RANGE 5.9592 | 29.077 kg/m^2 FULL_RANGE 4.6509 | 30.452 kg/m^2 FULL_RANGE 4.9601 | 29.448 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 2 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 50 Participants | 22 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Height | 176.92 cm FULL_RANGE 8.855 | 177.83 cm FULL_RANGE 8.459 | 177.63 cm FULL_RANGE 7.58 | 177.46 cm |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 10 Participants | 0 Participants | 19 Participants |
| Race/Ethnicity, Customized White | 45 Participants | 43 Participants | 24 Participants | 112 Participants |
| Region of Enrollment Canada | 5 Participants | 6 Participants | 1 Participants | 12 Participants |
| Region of Enrollment United States | 51 Participants | 48 Participants | 23 Participants | 122 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 56 Participants | 54 Participants | 24 Participants | 134 Participants |
| Weight | 90.49 kg FULL_RANGE 21.632 | 92.16 kg FULL_RANGE 17.645 | 96.10 kg FULL_RANGE 17.297 | 92.92 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 53 / 56 | 50 / 54 | 23 / 24 |
| serious Total, serious adverse events | 10 / 56 | 7 / 54 | 2 / 24 |
Outcome results
Primary
Percentage of Participants With Effective Castration Rate Over 24 Weeks
Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits beginning after 4 weeks of treatment.
Time frame: Day 1 of Week 5 to Day 1 of Week 25
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix 80 mg | Percentage of Participants With Effective Castration Rate Over 24 Weeks | 91 percentage of participants |
| Relugolix 120 mg | Percentage of Participants With Effective Castration Rate Over 24 Weeks | 91 percentage of participants |
| Leuprorelin 22.5 mg | Percentage of Participants With Effective Castration Rate Over 24 Weeks | 96 percentage of participants |
Secondary
Change From Baseline in EORTC QLQ-C30
The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A positive change from Baseline in quality og life or functioning scales and negative change from Baseline in symptom or difficulties scales indicates improvement.
Time frame: Day 1 of Weeks 5, 13, 25, 37, 49, 73, 97, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 49, Day 1 | -3.7 score on a scale | Standard Deviation 15.85 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: End of Study | -8.9 score on a scale | Standard Deviation 13.52 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: EOT | 6.7 score on a scale | Standard Deviation 35.97 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 73, Day 1 | -2.9 score on a scale | Standard Deviation 11.84 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 73, Day 1 | -3.4 score on a scale | Standard Deviation 17.18 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 97, Day 1 | -5.3 score on a scale | Standard Deviation 15.77 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 97, Day 1 | 7.0 score on a scale | Standard Deviation 17.84 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: EOT | -5.2 score on a scale | Standard Deviation 16.55 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 5, Day 1 | 0.3 score on a scale | Standard Deviation 14.43 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 97, Day 1 | 10.5 score on a scale | Standard Deviation 27.34 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Follow-Up | -3.3 score on a scale | Standard Deviation 10.26 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 13, Day 1 | -2.3 score on a scale | Standard Deviation 15.37 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 73, Day 1 | 2.3 score on a scale | Standard Deviation 33.25 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: End of Study | -3.7 score on a scale | Standard Deviation 16.48 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 73, Day 1 | 4.6 score on a scale | Standard Deviation 17.19 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 49, Day 1 | 6.7 score on a scale | Standard Deviation 29.81 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 5, Day 1 | 1.9 score on a scale | Standard Deviation 13.74 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 13, Day 1 | -1.0 score on a scale | Standard Deviation 17.13 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 37, Day 1 | 2.2 score on a scale | Standard Deviation 24.75 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 13, Day 1 | 6.1 score on a scale | Standard Deviation 17.4 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 97, Day 1 | -6.6 score on a scale | Standard Deviation 20.71 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 25, Day 1 | 6.3 score on a scale | Standard Deviation 30.49 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 25, Day 1 | 6.3 score on a scale | Standard Deviation 21.12 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 49, Day 1 | 3.0 score on a scale | Standard Deviation 17.15 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 13, Day 1 | 2.6 score on a scale | Standard Deviation 20.92 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 37, Day 1 | 9.7 score on a scale | Standard Deviation 21.55 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 25, Day 1 | -4.9 score on a scale | Standard Deviation 21.18 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 5, Day 1 | -1.3 score on a scale | Standard Deviation 24.43 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 49, Day 1 | 10.9 score on a scale | Standard Deviation 24.33 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Follow-Up | -5.4 score on a scale | Standard Deviation 12.17 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: End of Study | 11.1 score on a scale | Standard Deviation 19.52 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 73, Day 1 | 10.0 score on a scale | Standard Deviation 24.19 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 37, Day 1 | 3.6 score on a scale | Standard Deviation 17.54 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: EOT | 12.1 score on a scale | Standard Deviation 27.53 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 37, Day 1 | -10.9 score on a scale | Standard Deviation 23.1 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Follow-Up | 11.7 score on a scale | Standard Deviation 22.36 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Follow-up | 7.2 score on a scale | Standard Deviation 15.41 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: EOT | -4.8 score on a scale | Standard Deviation 16.82 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: EOT | 7.6 score on a scale | Standard Deviation 24.37 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: End of study | 11.4 score on a scale | Standard Deviation 17.72 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 25, Day 1 | 2.8 score on a scale | Standard Deviation 17.97 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 97, Day 1 | 10.5 score on a scale | Standard Deviation 19.41 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 5, Day 1 | -1.3 score on a scale | Standard Deviation 6.41 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 49, Day 1 | -8.1 score on a scale | Standard Deviation 23.2 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 73, Day 1 | 8.0 score on a scale | Standard Deviation 19.22 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 13, Day 1 | 0.7 score on a scale | Standard Deviation 7.42 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: End of Study | -7.9 score on a scale | Standard Deviation 18.14 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 49, Day 1 | 6.7 score on a scale | Standard Deviation 22.02 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 25, Day 1 | 0.0 score on a scale | Standard Deviation 9.1 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 13, Day 1 | 3.9 score on a scale | Standard Deviation 18.44 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 37, Day 1 | 6.5 score on a scale | Standard Deviation 21.8 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 37, Day 1 | 0.4 score on a scale | Standard Deviation 8.95 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 73, Day 1 | -8.0 score on a scale | Standard Deviation 13.08 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 25, Day 1 | 4.2 score on a scale | Standard Deviation 26.3 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 49, Day 1 | -1.9 score on a scale | Standard Deviation 7.3 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: Follow-Up | 5.0 score on a scale | Standard Deviation 12.21 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 13, Day 1 | 5.9 score on a scale | Standard Deviation 22.81 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 73, Day 1 | 0.0 score on a scale | Standard Deviation 4.45 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 97, Day 1 | -8.8 score on a scale | Standard Deviation 15.08 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 97, Day 1 | 5.3 score on a scale | Standard Deviation 14.75 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 49, Day 1 | -5.2 score on a scale | Standard Deviation 20.04 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week EOT | -0.5 score on a scale | Standard Deviation 8.56 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: EOT | -9.5 score on a scale | Standard Deviation 21.88 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 5, Day 1 | -0.6 score on a scale | Standard Deviation 21.17 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Follow-Up | 3.3 score on a scale | Standard Deviation 16.75 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 5, Day 1 | 0.9 score on a scale | Standard Deviation 9.87 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: End of Study | 6.5 score on a scale | Standard Deviation 17.03 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: End of Study | 1.4 score on a scale | Standard Deviation 9.24 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 5, Day 1 | -1.9 score on a scale | Standard Deviation 12.08 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Follow-Up | 9.2 score on a scale | Standard Deviation 21.95 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 5, Day 1 | -1.6 score on a scale | Standard Deviation 16.75 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Follow-Up | -10.0 score on a scale | Standard Deviation 16.58 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: EOT | -0.5 score on a scale | Standard Deviation 25.08 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 13, Day 1 | -1.0 score on a scale | Standard Deviation 17.77 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 25, Day 1 | -6.4 score on a scale | Standard Deviation 20.21 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 97, Day 1 | 5.3 score on a scale | Standard Deviation 19.29 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 25, Day 1 | 0.3 score on a scale | Standard Deviation 22.67 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: End Of Study | 3.7 score on a scale | Standard Deviation 19.15 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 73, Day 1 | 6.9 score on a scale | Standard Deviation 18.64 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 37, Day 1 | 2.9 score on a scale | Standard Deviation 23.65 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: End of Study | -10.6 score on a scale | Standard Deviation 12.69 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 49, Day 1 | 3.3 score on a scale | Standard Deviation 23.19 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 37, Day 1 | -2.9 score on a scale | Standard Deviation 19.66 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Follow-Up | 5.0 score on a scale | Standard Deviation 24.84 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 5, Day 1 | 1.9 score on a scale | Standard Deviation 8.59 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 13, Day 1 | 0.3 score on a scale | Standard Deviation 9.23 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: EOT | 3.8 score on a scale | Standard Deviation 22.54 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 13, Day 1 | -0.7 score on a scale | Standard Deviation 11.53 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 5, Day 1 | -2.7 score on a scale | Standard Deviation 14.51 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 97, Day 1 | 1.8 score on a scale | Standard Deviation 26 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 37, Day 1 | -4.3 score on a scale | Standard Deviation 12.26 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 25, Day 1 | -3.5 score on a scale | Standard Deviation 12.38 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 73, Day 1 | 1.1 score on a scale | Standard Deviation 18.86 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 49, Day 1 | -3.0 score on a scale | Standard Deviation 14.01 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 25, Day 1 | -2.8 score on a scale | Standard Deviation 15.24 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 49, Day 1 | 2.2 score on a scale | Standard Deviation 19.33 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 73, Day 1 | -2.0 score on a scale | Standard Deviation 9.36 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: EOT | -3.8 score on a scale | Standard Deviation 19.42 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 97, Day 1 | -2.6 score on a scale | Standard Deviation 12.44 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 13, Day 1 | -2.0 score on a scale | Standard Deviation 16.88 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: EOT | -3.6 score on a scale | Standard Deviation 11.3 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 37, Day 1 | -4.8 score on a scale | Standard Deviation 13.6 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 37, Day 1 | 5.8 score on a scale | Standard Deviation 20.25 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Follow-Up | -3.3 score on a scale | Standard Deviation 8.72 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 37, Day 1 | -6.0 score on a scale | Standard Deviation 20.69 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 13, Day 1 | 3.9 score on a scale | Standard Deviation 21.75 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: End of Study | -5.3 score on a scale | Standard Deviation 12.62 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 97, Day 1 | 5.8 score on a scale | Standard Deviation 22.94 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 5, Day 1 | 0.6 score on a scale | Standard Deviation 20.14 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 5, Day 1 | -0.9 score on a scale | Standard Deviation 11.97 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 5, Day 1 | -1.3 score on a scale | Standard Deviation 9.16 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: End of Study | -1.9 score on a scale | Standard Deviation 13.67 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 13, Day 1 | -1.0 score on a scale | Standard Deviation 13.5 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 49, Day 1 | -4.3 score on a scale | Standard Deviation 13.79 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Follow-Up | 0.0 score on a scale | Standard Deviation 15.29 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 25, Day 1 | -0.7 score on a scale | Standard Deviation 14.16 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 25, Day 1 | 2.8 score on a scale | Standard Deviation 19.25 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: EOT | -3.8 score on a scale | Standard Deviation 15.7 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 37, Day 1 | -5.8 score on a scale | Standard Deviation 12.28 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: End Of Study | 1.9 score on a scale | Standard Deviation 17.72 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 97, Day 1 | 0.0 score on a scale | Standard Deviation 15.71 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 49, Day 1 | -2.6 score on a scale | Standard Deviation 12.29 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 73, Day 1 | -5.1 score on a scale | Standard Deviation 9.2 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 73, Day 1 | -2.3 score on a scale | Standard Deviation 12.38 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 73, Day 1 | -5.7 score on a scale | Standard Deviation 15.61 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: Week 97, Day 1 | 5.3 score on a scale | Standard Deviation 20.07 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 97, Day 1 | -6.1 score on a scale | Standard Deviation 8.26 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 97, Day 1 | -8.1 score on a scale | Standard Deviation 9.58 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: EOT | -2.9 score on a scale | Standard Deviation 14.84 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 49, Day 1 | -7.2 score on a scale | Standard Deviation 19.18 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 49, Day 1 | -0.7 score on a scale | Standard Deviation 16.65 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Follow-Up | -0.8 score on a scale | Standard Deviation 14.78 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: EOT | -3.4 score on a scale | Standard Deviation 15.37 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 37, Day 1 | -0.7 score on a scale | Standard Deviation 17.9 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: End of Study | -2.3 score on a scale | Standard Deviation 16.01 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: End of Study | -2.8 score on a scale | Standard Deviation 18.47 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 25, Day 1 | -3.5 score on a scale | Standard Deviation 19.74 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 5, Day 1 | 0.3 score on a scale | Standard Deviation 16.5 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Follow-Up | 3.3 score on a scale | Standard Deviation 10.26 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 13, Day 1 | -0.7 score on a scale | Standard Deviation 18.25 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 13, Day 1 | 1.6 score on a scale | Standard Deviation 13.85 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Follow-Up | -4.0 score on a scale | Standard Deviation 9.02 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 5, Day 1 | -3.8 score on a scale | Standard Deviation 14.11 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 25, Day 1 | -1.0 score on a scale | Standard Deviation 16.98 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 73, Day 1 | 0.0 score on a scale | Standard Deviation 8.91 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: End of Study | 1.9 score on a scale | Standard Deviation 28.67 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 37, Day 1 | -2.5 score on a scale | Standard Deviation 18.58 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: EOT | 4.8 score on a scale | Standard Deviation 14.33 |
| Relugolix 80 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Follow-Up | 5.0 score on a scale | Standard Deviation 19.57 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 13, Day 1 | 5.2 score on a scale | Standard Deviation 19.29 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 97, Day 1 | 9.9 score on a scale | Standard Deviation 18.48 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 5, Day 1 | -4.0 score on a scale | Standard Deviation 17.5 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 13, Day 1 | -2.0 score on a scale | Standard Deviation 14.87 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 25, Day 1 | -2.3 score on a scale | Standard Deviation 15.45 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 37, Day 1 | -7.4 score on a scale | Standard Deviation 20.58 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 49, Day 1 | -7.3 score on a scale | Standard Deviation 18.18 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 73, Day 1 | -12.0 score on a scale | Standard Deviation 13.19 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 97, Day 1 | -2.2 score on a scale | Standard Deviation 18.18 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: End of Study | -10.1 score on a scale | Standard Deviation 15.49 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 5, Day 1 | -0.9 score on a scale | Standard Deviation 7.7 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 13, Day 1 | -4.4 score on a scale | Standard Deviation 8.5 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 25, Day 1 | -5.3 score on a scale | Standard Deviation 10.2 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 37, Day 1 | -6.2 score on a scale | Standard Deviation 12.26 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 49, Day 1 | -5.2 score on a scale | Standard Deviation 9.95 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 73, Day 1 | -8.5 score on a scale | Standard Deviation 8.72 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 97, Day 1 | -6.0 score on a scale | Standard Deviation 8.86 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: EOT | -9.3 score on a scale | Standard Deviation 14.66 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Follow-Up | -6.3 score on a scale | Standard Deviation 19.18 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: End of Study | -9.0 score on a scale | Standard Deviation 13.48 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 5, Day 1 | -0.3 score on a scale | Standard Deviation 15.3 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 13, Day 1 | -3.6 score on a scale | Standard Deviation 16.09 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 25, Day 1 | -6.3 score on a scale | Standard Deviation 19.03 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 37, Day 1 | -10.0 score on a scale | Standard Deviation 16.82 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 49, Day 1 | -8.9 score on a scale | Standard Deviation 22.7 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 73, Day 1 | -6.7 score on a scale | Standard Deviation 14.43 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 97, Day 1 | -4.4 score on a scale | Standard Deviation 12.22 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: EOT | -8.6 score on a scale | Standard Deviation 20.76 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Follow-Up | -10.5 score on a scale | Standard Deviation 31.04 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: End of Study | -13.2 score on a scale | Standard Deviation 21.99 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 5, Day 1 | 0.3 score on a scale | Standard Deviation 12.45 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 13, Day 1 | -1.1 score on a scale | Standard Deviation 12.7 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 37, Day 1 | -1.7 score on a scale | Standard Deviation 11.73 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 49, Day 1 | -1.4 score on a scale | Standard Deviation 12.06 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 73, Day 1 | -2.3 score on a scale | Standard Deviation 16.578 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 97, Day 1 | 2.6 score on a scale | Standard Deviation 7.88 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: EOT | -7.4 score on a scale | Standard Deviation 17.12 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Follow-Up | -1.3 score on a scale | Standard Deviation 19.5 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: End of Study | -0.6 score on a scale | Standard Deviation 14.42 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 5, Day 1 | -4.2 score on a scale | Standard Deviation 14.71 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 13, Day 1 | -7.5 score on a scale | Standard Deviation 16.44 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 25, Day 1 | -3.8 score on a scale | Standard Deviation 15.08 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 37, Day 1 | -5.6 score on a scale | Standard Deviation 16.67 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 49, Day 1 | -6.1 score on a scale | Standard Deviation 13.82 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 73, Day 1 | -7.3 score on a scale | Standard Deviation 13.68 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 97, Day 1 | -7.0 score on a scale | Standard Deviation 13.96 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: EOT | -10.0 score on a scale | Standard Deviation 23.64 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Follow-Up | -7.0 score on a scale | Standard Deviation 21.74 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: End of Study | -7.5 score on a scale | Standard Deviation 18.14 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 5, Day 1 | -1.3 score on a scale | Standard Deviation 14.33 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 13, Day 1 | -3.3 score on a scale | Standard Deviation 12.48 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 25, Day 1 | -6.3 score on a scale | Standard Deviation 20.23 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 37, Day 1 | -5.9 score on a scale | Standard Deviation 16.34 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 49, Day 1 | -9.8 score on a scale | Standard Deviation 20.74 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 73, Day 1 | -6.0 score on a scale | Standard Deviation 15.12 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 97, Day 1 | -4.4 score on a scale | Standard Deviation 14.53 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: EOT | -10.0 score on a scale | Standard Deviation 21.08 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Follow-Up | -8.8 score on a scale | Standard Deviation 25.07 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: End of Study | -9.2 score on a scale | Standard Deviation 19.2 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 5, Day 1 | 4.3 score on a scale | Standard Deviation 14.95 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 13, Day 1 | 8.9 score on a scale | Standard Deviation 15.72 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 25, Day 1 | 13.2 score on a scale | Standard Deviation 15.66 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 37, Day 1 | 14.1 score on a scale | Standard Deviation 19.3 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 49, Day 1 | 11.1 score on a scale | Standard Deviation 16.67 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 73, Day 1 | 14.7 score on a scale | Standard Deviation 13.88 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: EOT | 15.9 score on a scale | Standard Deviation 20.22 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Follow-up | 6.4 score on a scale | Standard Deviation 19.71 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: End of study | 12.3 score on a scale | Standard Deviation 22.88 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 5, Day 1 | 0.6 score on a scale | Standard Deviation 9.88 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 13, Day 1 | 0.7 score on a scale | Standard Deviation 7.42 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 25, Day 1 | 0.0 score on a scale | Standard Deviation 3.44 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 37, Day 1 | 1.1 score on a scale | Standard Deviation 7.45 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 49, Day 1 | 0.8 score on a scale | Standard Deviation 6.4 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 73, Day 1 | 0.7 score on a scale | Standard Deviation 3.33 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 97, Day 1 | 1.8 score on a scale | Standard Deviation 9.45 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week EOT | 1.9 score on a scale | Standard Deviation 8.83 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Follow-Up | 0.9 score on a scale | Standard Deviation 3.82 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: End of Study | -1.1 score on a scale | Standard Deviation 4.3 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 5, Day 1 | 0.6 score on a scale | Standard Deviation 16.82 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 13, Day 1 | 3.3 score on a scale | Standard Deviation 18.86 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 25, Day 1 | 2.8 score on a scale | Standard Deviation 16.61 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 37, Day 1 | 5.9 score on a scale | Standard Deviation 21.37 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 49, Day 1 | 6.5 score on a scale | Standard Deviation 18.59 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 73, Day 1 | 7.3 score on a scale | Standard Deviation 14.5 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 97, Day 1 | 0.0 score on a scale | Standard Deviation 14.7 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: EOT | 6.7 score on a scale | Standard Deviation 24.32 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Follow-Up | 10.5 score on a scale | Standard Deviation 23.05 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Pain: End of Study | 6.9 score on a scale | Standard Deviation 19.17 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 5, Day 1 | 2.6 score on a scale | Standard Deviation 17.27 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 13, Day 1 | 6.5 score on a scale | Standard Deviation 21.1 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 25, Day 1 | 8.3 score on a scale | Standard Deviation 22.28 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 37, Day 1 | 11.1 score on a scale | Standard Deviation 22.47 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 49, Day 1 | 9.8 score on a scale | Standard Deviation 20.06 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 73, Day 1 | 9.3 score on a scale | Standard Deviation 18.05 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 97, Day 1 | 8.8 score on a scale | Standard Deviation 18.73 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: EOT | 14.3 score on a scale | Standard Deviation 20.27 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Follow-Up | 8.8 score on a scale | Standard Deviation 26.86 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: End of Study | 14.9 score on a scale | Standard Deviation 26.1 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 5, Day 1 | 3.2 score on a scale | Standard Deviation 17.79 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 13, Day 1 | 9.8 score on a scale | Standard Deviation 21.39 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 25, Day 1 | 12.5 score on a scale | Standard Deviation 24.43 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 37, Day 1 | 8.1 score on a scale | Standard Deviation 22.65 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 49, Day 1 | 7.3 score on a scale | Standard Deviation 22.99 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 73, Day 1 | 10.7 score on a scale | Standard Deviation 23.01 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 97, Day 1 | 10.5 score on a scale | Standard Deviation 19.41 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: EOT | 7.6 score on a scale | Standard Deviation 26.92 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Follow-Up | 0.0 score on a scale | Standard Deviation 27.22 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: End of Study | 5.7 score on a scale | Standard Deviation 21.95 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 5, Day 1 | 0.6 score on a scale | Standard Deviation 21.38 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 13, Day 1 | -0.7 score on a scale | Standard Deviation 20.54 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 25, Day 1 | 0.0 score on a scale | Standard Deviation 19.45 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 37, Day 1 | 2.2 score on a scale | Standard Deviation 16.51 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 49, Day 1 | 0.8 score on a scale | Standard Deviation 15.79 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 73, Day 1 | 5.3 score on a scale | Standard Deviation 18.46 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 97, Day 1 | 3.5 score on a scale | Standard Deviation 15.29 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: EOT | 8.6 score on a scale | Standard Deviation 16.85 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Follow-Up | 3.5 score on a scale | Standard Deviation 18.9 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: End of Study | 3.4 score on a scale | Standard Deviation 13.64 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 5, Day 1 | 1.9 score on a scale | Standard Deviation 17.97 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 25, Day 1 | 6.3 score on a scale | Standard Deviation 25.41 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 37, Day 1 | 8.1 score on a scale | Standard Deviation 26.74 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 49, Day 1 | 7.3 score on a scale | Standard Deviation 20.43 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 73, Day 1 | 1.3 score on a scale | Standard Deviation 17.95 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 97, Day 1 | 3.5 score on a scale | Standard Deviation 21.93 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: EOT | 1.9 score on a scale | Standard Deviation 17.97 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Follow-Up | 10.5 score on a scale | Standard Deviation 24.98 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: End Of Study | 5.7 score on a scale | Standard Deviation 17.97 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 5, Day 1 | 1.9 score on a scale | Standard Deviation 13.87 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 13, Day 1 | 2.0 score on a scale | Standard Deviation 23.49 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 25, Day 1 | 5.6 score on a scale | Standard Deviation 19.85 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 37, Day 1 | 0.7 score on a scale | Standard Deviation 15.06 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 49, Day 1 | -1.6 score on a scale | Standard Deviation 16.59 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 73, Day 1 | 1.3 score on a scale | Standard Deviation 15.15 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 97, Day 1 | 0.0 score on a scale | Standard Deviation 15.71 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: EOT | 2.9 score on a scale | Standard Deviation 16.9 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Follow-Up | 0.0 score on a scale | Standard Deviation 19.25 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: End Of Study | -1.1 score on a scale | Standard Deviation 18.86 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 5, Day 1 | 2.6 score on a scale | Standard Deviation 21.74 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 13, Day 1 | -0.7 score on a scale | Standard Deviation 20.54 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 25, Day 1 | 0.7 score on a scale | Standard Deviation 20.03 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 37, Day 1 | 1.5 score on a scale | Standard Deviation 18.74 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 49, Day 1 | 0.8 score on a scale | Standard Deviation 18.99 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 73, Day 1 | 2.7 score on a scale | Standard Deviation 16.44 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: Week 97, Day 1 | 1.8 score on a scale | Standard Deviation 20.71 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: EOT | 5.7 score on a scale | Standard Deviation 20.59 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: Follow-Up | 1.8 score on a scale | Standard Deviation 20.71 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: End of Study | 3.4 score on a scale | Standard Deviation 22.44 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: EOT | -7.1 score on a scale | Standard Deviation 15.8 |
| Relugolix 120 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Follow-Up | -8.8 score on a scale | Standard Deviation 22.13 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 37, Day 1 | -11.7 score on a scale | Standard Deviation 18.84 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Follow-Up | 4.8 score on a scale | Standard Deviation 25.68 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 25, Day 1 | -202 score on a scale | Standard Deviation 22.08 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Follow-Up | -3.8 score on a scale | Standard Deviation 21.52 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: End of Study | 10.4 score on a scale | Standard Deviation 29.11 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 13, Day 1 | -0.7 score on a scale | Standard Deviation 18.04 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: End of Study | 0.0 score on a scale | Standard Deviation 21.08 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 5, Day 1 | 2.8 score on a scale | Standard Deviation 13.61 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 5, Day 1 | 4.2 score on a scale | Standard Deviation 16.48 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: EOT | 5.1 score on a scale | Standard Deviation 18.49 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 13, Day 1 | 0.0 score on a scale | Standard Deviation 13.9 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: End of Study | -3.1 score on a scale | Standard Deviation 16.35 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: EOT | -2.6 score on a scale | Standard Deviation 22.2 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 25, Day 1 | 2.9 score on a scale | Standard Deviation 17.15 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Follow-Up | -10.7 score on a scale | Standard Deviation 15.48 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 25, Day 1 | -6.9 score on a scale | Standard Deviation 16.98 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 37, Day 1 | 0.0 score on a scale | Standard Deviation 14.55 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: EOT | -12.8 score on a scale | Standard Deviation 21.68 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Follow-Up | 4.8 score on a scale | Standard Deviation 12.1 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Week 49, Day 1 | 4.8 score on a scale | Standard Deviation 15.94 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 49, Day 1 | -11.9 score on a scale | Standard Deviation 16.79 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 49, Day 1 | -7.0 score on a scale | Standard Deviation 17.32 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 37, Day 1 | -9.8 score on a scale | Standard Deviation 15.99 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Follow-Up | -13.7 score on a scale | Standard Deviation 19.5 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 25, Day 1 | -2.9 score on a scale | Standard Deviation 11.95 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: End Of Study | 2.1 score on a scale | Standard Deviation 19.12 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: EOT | 2.6 score on a scale | Standard Deviation 16.45 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 13, Day 1 | -5.6 score on a scale | Standard Deviation 16.05 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 37, Day 1 | -4.2 score on a scale | Standard Deviation 16.78 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: Follow-Up | -2.4 score on a scale | Standard Deviation 15.82 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Cognitive Functioning: Week 5, Day 1 | -2.8 score on a scale | Standard Deviation 10.62 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: EOT | 2.6 score on a scale | Standard Deviation 16.45 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Appetite Loss: End of Study | 0.0 score on a scale | Standard Deviation 24.34 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: End of Study | -8.3 score on a scale | Standard Deviation 17.74 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 5, Day 1 | -1.4 score on a scale | Standard Deviation 18.33 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 5, Day 1 | 1.4 score on a scale | Standard Deviation 6.8 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Follow-Up | -8.9 score on a scale | Standard Deviation 23.22 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 25, Day 1 | -2.0 score on a scale | Standard Deviation 14.42 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 25, Day 1 | 1.4 score on a scale | Standard Deviation 15.82 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: EOT | -14.1 score on a scale | Standard Deviation 24.15 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 13, Day 1 | -7.3 score on a scale | Standard Deviation 15.21 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 37, Day 1 | 1.5 score on a scale | Standard Deviation 12.5 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 49, Day 1 | -4.4 score on a scale | Standard Deviation 18.56 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 13, Day 1 | 2.8 score on a scale | Standard Deviation 23.91 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 49, Day 1 | 1.6 score on a scale | Standard Deviation 7.27 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 37, Day 1 | -9.8 score on a scale | Standard Deviation 20.35 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 13, Day 1 | -0.3 score on a scale | Standard Deviation 14.77 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 13, Day 1 | -1.4 score on a scale | Standard Deviation 12.69 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: EOT | -13.5 score on a scale | Standard Deviation 24.19 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Emotional Functioning: Week 5, Day 1 | 1.7 score on a scale | Standard Deviation 10.98 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 25, Day 1 | 4.3 score on a scale | Standard Deviation 23.15 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: EOT | 0.0 score on a scale | Standard Deviation 13.61 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 37, Day 1 | 11.4 score on a scale | Standard Deviation 34.27 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: End of Study | -1.0 score on a scale | Standard Deviation 26.15 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 49, Day 1 | 7.9 score on a scale | Standard Deviation 31.46 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 25, Day 1 | 2.9 score on a scale | Standard Deviation 22.84 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: Week 5, Day 1 | -0.8 score on a scale | Standard Deviation 8.41 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 13, Day 1 | 4.2 score on a scale | Standard Deviation 26.12 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Follow-Up | 0.0 score on a scale | Standard Deviation 13.07 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Week 5, Day 1 | 3.5 score on a scale | Standard Deviation 18.38 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Follow-Up | -7.1 score on a scale | Standard Deviation 29.75 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Pain: EOT | 6.4 score on a scale | Standard Deviation 35.05 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: End of Study | 0.0 score on a scale | Standard Deviation 6.09 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties: Follow-Up | 11.9 score on a scale | Standard Deviation 33.61 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Pain: Follow-Up | 1.2 score on a scale | Standard Deviation 28.84 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Follow-Up | 0.0 score on a scale | Standard Deviation 6.54 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: End Of Study | 0.0 score on a scale | Standard Deviation 17.21 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Pain: End of Study | -2.1 score on a scale | Standard Deviation 30.96 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week EOT | 7.7 score on a scale | Standard Deviation 14.62 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: EOT | -5.1 score on a scale | Standard Deviation 29.17 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 5, Day 1 | 5.6 score on a scale | Standard Deviation 18.82 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 49, Day 1 | 4.8 score on a scale | Standard Deviation 11.95 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 37, Day 1 | 7.6 score on a scale | Standard Deviation 20.4 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 13, Day 1 | 8.3 score on a scale | Standard Deviation 20.26 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 37, Day 1 | 4.5 score on a scale | Standard Deviation 9.17 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 5, Day 1 | 1.4 score on a scale | Standard Deviation 11.95 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 25, Day 1 | 8.7 score on a scale | Standard Deviation 22.96 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 25, Day 1 | 2.9 score on a scale | Standard Deviation 6.46 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 49, Day 1 | -7.1 score on a scale | Standard Deviation 19.42 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 37, Day 1 | 22.7 score on a scale | Standard Deviation 26 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 13, Day 1 | 1.4 score on a scale | Standard Deviation 4.71 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: End of Study | -10.9 score on a scale | Standard Deviation 13.85 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Week 49, Day 1 | 17.5 score on a scale | Standard Deviation 30.95 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Nausea and Vomiting: Week 5, Day 1 | 3.5 score on a scale | Standard Deviation 6.91 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 13, Day 1 | 0.0 score on a scale | Standard Deviation 9.83 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: End of study | 8.3 score on a scale | Standard Deviation 19.25 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 37, Day 1 | -4.5 score on a scale | Standard Deviation 24.22 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Follow-up | 13.5 score on a scale | Standard Deviation 21.87 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 5, Day 1 | -5.2 score on a scale | Standard Deviation 13.64 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: EOT | 20.5 score on a scale | Standard Deviation 32.03 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: EOT | 20.5 score on a scale | Standard Deviation 18.62 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 25, Day 1 | 2.9 score on a scale | Standard Deviation 13.9 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: Follow-Up | 14.3 score on a scale | Standard Deviation 25.2 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 49, Day 1 | 20.1 score on a scale | Standard Deviation 23.47 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 25, Day 1 | -2.2 score on a scale | Standard Deviation 23.19 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Dyspnea: End of Study | 8.3 score on a scale | Standard Deviation 31.03 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 37, Day 1 | 16.7 score on a scale | Standard Deviation 21.89 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Financial Difficulties:Week 49, Day 1 | 3.2 score on a scale | Standard Deviation 17.97 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 5, Day 1 | 1.4 score on a scale | Standard Deviation 18.33 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 25, Day 1 | 13.5 score on a scale | Standard Deviation 18.94 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 37, Day 1 | 6.1 score on a scale | Standard Deviation 13.16 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 13, Day 1 | 6.9 score on a scale | Standard Deviation 19.61 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 13, Day 1 | 8.3 score on a scale | Standard Deviation 11.47 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 13, Day 1 | 1.4 score on a scale | Standard Deviation 21.93 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 25, Day 1 | 8.7 score on a scale | Standard Deviation 22.96 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Fatigue: Week 5, Day 1 | 3.2 score on a scale | Standard Deviation 15.19 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Quality of Life: Week 49, Day 1 | -8.3 score on a scale | Standard Deviation 17.87 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 37, Day 1 | 18.2 score on a scale | Standard Deviation 32.08 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: End of Study | 0.0 score on a scale | Standard Deviation 14.91 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Diarrhea: Week 49, Day 1 | 1.6 score on a scale | Standard Deviation 16.59 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: Week 49, Day 1 | 6.3 score on a scale | Standard Deviation 32.69 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Follow-Up | -4.8 score on a scale | Standard Deviation 22.1 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Role Functioning: Week 5, Day 1 | 2.8 score on a scale | Standard Deviation 8.03 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: EOT | -6.4 score on a scale | Standard Deviation 30.84 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Constipation: Week 13, Day 1 | 5.6 score on a scale | Standard Deviation 12.69 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 49, Day 1 | -8.7 score on a scale | Standard Deviation 26.15 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Physical Functioning: End of Study | -2.9 score on a scale | Standard Deviation 20.22 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Insomnia: EOT | 7.7 score on a scale | Standard Deviation 24.17 |
| Leuprorelin 22.5 mg | Change From Baseline in EORTC QLQ-C30 | Social Functioning: Week 37, Day 1 | -7.6 score on a scale | Standard Deviation 20.4 |
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score
EORTC QLQ-PR25 is an EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer consisting of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions use are answered using a 4-point scale: 1=Not at all to 4 =Very much. All raw domain scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). A positive change from Baseline in activity or functioning scales and negative change from Baseline in symptom scales indicates improvement.
Time frame: Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 5, Day 1 | 2.0 score on a scale | Standard Deviation 12.6 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: EOT | -15.7 score on a scale | Standard Deviation 18.05 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: End of Study | 2.1 score on a scale | Standard Deviation 5.03 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 13, Day 1 | 1.9 score on a scale | Standard Deviation 11.64 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Follow-up | 0.0 score on a scale | Standard Deviation 21.08 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Follow-up | 0.0 score on a scale | Standard Deviation 4.68 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 25, Day 1 | 3.6 score on a scale | Standard Deviation 15.46 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 25, Day 1 | 3.5 score on a scale | Standard Deviation 21.93 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: EOT | 2.1 score on a scale | Standard Deviation 6.18 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 37, Day 1 | 3.4 score on a scale | Standard Deviation 14.89 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Follow-up | -9.2 score on a scale | Standard Deviation 18.32 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 49, Day 1 | 3.0 score on a scale | Standard Deviation 6.44 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 49, Day 1 | 4.0 score on a scale | Standard Deviation 11.98 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 13, Day 1 | 0.0 score on a scale | Standard Deviation 22.22 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 37, Day 1 | 3.8 score on a scale | Standard Deviation 7.8 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: EOT | 3.3 score on a scale | Standard Deviation 14 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: End of Study | -7.9 score on a scale | Standard Deviation 25.04 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 25, Day 1 | 3.1 score on a scale | Standard Deviation 7.22 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Follow-up | -1.0 score on a scale | Standard Deviation 11.3 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 25, Day 1 | -9.4 score on a scale | Standard Deviation 25.24 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 13, Day 1 | 1.0 score on a scale | Standard Deviation 4.95 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: End of study | 2.2 score on a scale | Standard Deviation 10.84 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 5, Day 1 | 0.0 score on a scale | Standard Deviation 21.63 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 5, Day 1 | 1.9 score on a scale | Standard Deviation 7.24 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 5, Day 1 | -9.9 score on a scale | Standard Deviation 24.53 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: End of Study | 0.0 score on a scale | Standard Deviation 20.1 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: End of Study | 10.8 score on a scale | Standard Deviation 11.03 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 13, Day 1 | -8.3 score on a scale | Standard Deviation 20.89 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: EOT | 6.1 score on a scale | Standard Deviation 20.1 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Follow-up | 7.5 score on a scale | Standard Deviation 8.51 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 25, Day 1 | -4.7 score on a scale | Standard Deviation 22.97 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 37, Day 1 | -12.0 score on a scale | Standard Deviation 27.81 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: EOT | 12.9 score on a scale | Standard Deviation 12.33 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 37, Day 1 | -10.7 score on a scale | Standard Deviation 18.9 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 13, Day 1 | -9.3 score on a scale | Standard Deviation 18.49 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 49, Day 1 | 14.4 score on a scale | Standard Deviation 12.39 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 49, Day 1 | -16.7 score on a scale | Standard Deviation 23.84 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 49, Day 1 | 7.0 score on a scale | Standard Deviation 23.78 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 37, Day 1 | 13.3 score on a scale | Standard Deviation 10.51 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: EOT | -16.7 score on a scale | Standard Deviation 25.97 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 49, Day 1 | -13.0 score on a scale | Standard Deviation 28.4 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 25, Day 1 | 11.7 score on a scale | Standard Deviation 10.07 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Follow-up | 3.1 score on a scale | Standard Deviation 21.33 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 5, Day 1 | -6.0 score on a scale | Standard Deviation 29.25 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 13, Day 1 | 9.2 score on a scale | Standard Deviation 9.95 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: End of Study | -11.5 score on a scale | Standard Deviation 22.7 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 37, Day 1 | 8.3 score on a scale | Standard Deviation 25.82 |
| Relugolix 80 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 5, Day 1 | 5.6 score on a scale | Standard Deviation 8.98 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Follow-up | -24.6 score on a scale | Standard Deviation 32.09 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 5, Day 1 | -14.4 score on a scale | Standard Deviation 22.39 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 13, Day 1 | -17.3 score on a scale | Standard Deviation 27.28 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 25, Day 1 | -19.8 score on a scale | Standard Deviation 31.82 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 37, Day 1 | -14.4 score on a scale | Standard Deviation 31.7 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 49, Day 1 | -19.1 score on a scale | Standard Deviation 36.24 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: EOT | -18.1 score on a scale | Standard Deviation 43.79 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: End of Study | -15.5 score on a scale | Standard Deviation 35.89 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 5, Day 1 | -2.0 score on a scale | Standard Deviation 29.25 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 13, Day 1 | -1.4 score on a scale | Standard Deviation 29.27 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 25, Day 1 | -12.5 score on a scale | Standard Deviation 33.8 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 37, Day 1 | -12.8 score on a scale | Standard Deviation 17.55 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 49, Day 1 | -13.9 score on a scale | Standard Deviation 27.95 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: EOT | -10.7 score on a scale | Standard Deviation 6.3 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Follow-up | -10.4 score on a scale | Standard Deviation 18.48 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: End of Study | -4.2 score on a scale | Standard Deviation 21.96 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 5, Day 1 | 1.8 score on a scale | Standard Deviation 7.84 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 13, Day 1 | 3.8 score on a scale | Standard Deviation 7.54 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 25, Day 1 | 5.1 score on a scale | Standard Deviation 12.28 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 37, Day 1 | 4.2 score on a scale | Standard Deviation 10.24 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 49, Day 1 | 6.5 score on a scale | Standard Deviation 11.18 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: EOT | 7.1 score on a scale | Standard Deviation 13.35 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Follow-up | 5.9 score on a scale | Standard Deviation 14.52 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: End of study | 4.5 score on a scale | Standard Deviation 14.04 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 5, Day 1 | 1.1 score on a scale | Standard Deviation 6.81 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 13, Day 1 | 1.8 score on a scale | Standard Deviation 8.55 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 25, Day 1 | 0.3 score on a scale | Standard Deviation 6.87 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 37, Day 1 | 1.5 score on a scale | Standard Deviation 7.6 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 49, Day 1 | 0.0 score on a scale | Standard Deviation 6.97 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: EOT | 2.4 score on a scale | Standard Deviation 7.98 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Follow-up | 2.2 score on a scale | Standard Deviation 9.95 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: End of Study | -0.3 score on a scale | Standard Deviation 6.49 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 5, Day 1 | 5.0 score on a scale | Standard Deviation 8.03 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 13, Day 1 | 10.8 score on a scale | Standard Deviation 10.8 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 25, Day 1 | 11.3 score on a scale | Standard Deviation 11.4 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 37, Day 1 | 12.2 score on a scale | Standard Deviation 13.17 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 49, Day 1 | 9.6 score on a scale | Standard Deviation 11.04 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: EOT | 14.0 score on a scale | Standard Deviation 16.13 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Follow-up | 6.1 score on a scale | Standard Deviation 9.05 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: End of Study | 9.8 score on a scale | Standard Deviation 11.27 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 5, Day 1 | -1.9 score on a scale | Standard Deviation 17.98 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 13, Day 1 | -1.8 score on a scale | Standard Deviation 13.49 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 25, Day 1 | 0.0 score on a scale | Standard Deviation 15.71 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 37, Day 1 | -1.8 score on a scale | Standard Deviation 13.49 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 49, Day 1 | -2.2 score on a scale | Standard Deviation 15.26 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: EOT | 6.1 score on a scale | Standard Deviation 20.1 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Follow-up | -8.3 score on a scale | Standard Deviation 15.43 |
| Relugolix 120 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: End of Study | -4.8 score on a scale | Standard Deviation 22.1 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: End of Study | -13.9 score on a scale | Standard Deviation 12.73 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 25, Day 1 | -16.7 score on a scale | Standard Deviation 23.57 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 5, Day 1 | 3.5 score on a scale | Standard Deviation 8.94 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Follow-up | 2.1 score on a scale | Standard Deviation 73.4 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 49, Day 1 | -17.5 score on a scale | Standard Deviation 31.39 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 13, Day 1 | 7.2 score on a scale | Standard Deviation 9.48 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: EOT | 37.5 score on a scale | Standard Deviation 53.03 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: End of Study | -33.3 score on a scale | Standard Deviation 0 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 25, Day 1 | 10.9 score on a scale | Standard Deviation 9.98 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 49, Day 1 | 6.0 score on a scale | Standard Deviation 23.43 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 37, Day 1 | -16.7 score on a scale | Standard Deviation 23.57 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 37, Day 1 | 13.2 score on a scale | Standard Deviation 13.32 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 37, Day 1 | -19.8 score on a scale | Standard Deviation 17.22 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 37, Day 1 | -14.3 score on a scale | Standard Deviation 21.27 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Week 49, Day 1 | 15.9 score on a scale | Standard Deviation 12.82 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 25, Day 1 | -16.7 score on a scale | Standard Deviation 23.07 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Follow-up | -33.3 score on a scale | Standard Deviation 0 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: EOT | 17.9 score on a scale | Standard Deviation 12.25 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 13, Day 1 | 0.8 score on a scale | Standard Deviation 27.34 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 49, Day 1 | -22.2 score on a scale | Standard Deviation 19.25 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: Follow-up | 15.9 score on a scale | Standard Deviation 15.69 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Functioning: Week 5, Day 1 | -4.2 score on a scale | Standard Deviation 14.43 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 25, Day 1 | -18.8 score on a scale | Standard Deviation 20.9 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | HTRS: End of Study | 12.5 score on a scale | Standard Deviation 12.75 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: End of study | 6.8 score on a scale | Standard Deviation 13.08 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: End of Study | -21.9 score on a scale | Standard Deviation 24.13 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 5, Day 1 | 0.3 score on a scale | Standard Deviation 5.75 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Follow-up | 9.8 score on a scale | Standard Deviation 7.42 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 5, Day 1 | -7.6 score on a scale | Standard Deviation 20.25 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 13, Day 1 | 2.4 score on a scale | Standard Deviation 7.57 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: EOT | 9.0 score on a scale | Standard Deviation 12.83 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 5, Day 1 | -16.7 score on a scale | Standard Deviation 19.25 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 25, Day 1 | 1.1 score on a scale | Standard Deviation 4.57 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 49, Day 1 | 9.9 score on a scale | Standard Deviation 11.45 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Follow-up | -14.3 score on a scale | Standard Deviation 34.5 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 37, Day 1 | 3.2 score on a scale | Standard Deviation 7.21 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 37, Day 1 | 12.9 score on a scale | Standard Deviation 14.61 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: EOT | -16.7 score on a scale | Standard Deviation 23.57 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Week 49, Day 1 | 2.4 score on a scale | Standard Deviation 7.04 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 25, Day 1 | 7.2 score on a scale | Standard Deviation 10.6 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Incontinence Aid: Week 13, Day 1 | -16.7 score on a scale | Standard Deviation 19.25 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: EOT | 2.6 score on a scale | Standard Deviation 6.26 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 13, Day 1 | 6.8 score on a scale | Standard Deviation 10.7 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: EOT | -30.8 score on a scale | Standard Deviation 27.09 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: Follow-up | 2.4 score on a scale | Standard Deviation 8.91 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Urinary Symptoms: Week 5, Day 1 | 4.2 score on a scale | Standard Deviation 7.57 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Sexual Activity: Week 13, Day 1 | -11.1 score on a scale | Standard Deviation 19.45 |
| Leuprorelin 22.5 mg | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score | Bowel Symptoms: End of Study | 1.0 score on a scale | Standard Deviation 9.56 |
Secondary
Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any AE that results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Time frame: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix 80 mg | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any Adverse Event | 53 participants |
| Relugolix 80 mg | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 10 participants |
| Relugolix 120 mg | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any Adverse Event | 53 participants |
| Relugolix 120 mg | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 7 participants |
| Leuprorelin 22.5 mg | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any Adverse Event | 23 participants |
| Leuprorelin 22.5 mg | Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
Secondary
Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings
A single 12-lead ECG was performed. ECGs were read and interpreted locally and reviewed if indicated by the study monitor. ECG abnormalities were reported as AEs.
Time frame: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relugolix 80 mg | Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | 0 participants |
Secondary
Number of Participants With TEAES Related to Clinical Laboratory Test Results
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
Time frame: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood bilirubin increased | 1 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Aspartate aminotransferase increased | 6 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Gamma-glutamyltransferase increased | 3 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood triglycerides increased | 3 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Alanine aminotransferase increased | 7 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Hepatic enzyme increased | 0 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Prostatic specific antigen increased | 1 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood cholesterol increased | 0 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Low density lipoprotein increased | 1 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood glucose increased | 1 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Glycosylated haemoglobin increased | 0 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood creatinine increased | 0 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood lactate dehydrogenase increased | 2 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood alkaline phosphatase increased | 1 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood phosphorus increased | 1 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood potassium increased | 1 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood thyroid stimulating hormone increased | 0 participants |
| Relugolix 80 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood testosterone increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood testosterone increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Alanine aminotransferase increased | 3 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood glucose increased | 1 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood lactate dehydrogenase increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Aspartate aminotransferase increased | 1 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood phosphorus increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood potassium increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Gamma-glutamyltransferase increased | 1 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Glycosylated haemoglobin increased | 1 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood thyroid stimulating hormone increased | 1 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood triglycerides increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Low density lipoprotein increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood alkaline phosphatase increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood bilirubin increased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood cholesterol increased | 2 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood creatinine increased | 1 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Hepatic enzyme increased | 1 participants |
| Relugolix 120 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Prostatic specific antigen increased | 1 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Hepatic enzyme increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Prostatic specific antigen increased | 1 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood cholesterol increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood phosphorus increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Low density lipoprotein increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood testosterone increased | 1 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood glucose increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Glycosylated haemoglobin increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood potassium increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood creatinine increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Alanine aminotransferase increased | 4 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Aspartate aminotransferase increased | 3 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood lactate dehydrogenase increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Gamma-glutamyltransferase increased | 2 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood triglycerides increased | 1 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood bilirubin increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood alkaline phosphatase increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAES Related to Clinical Laboratory Test Results | Blood thyroid stimulating hormone increased | 0 participants |
Secondary
Number of Participants With TEAEs Related to Physical Examination
Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10) including slit lamp examination of the anterior eye. Any TEAEs Related to physical examination were reported.
Time frame: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix 80 mg | Number of Participants With TEAEs Related to Physical Examination | Weight decreased | 1 participants |
| Relugolix 80 mg | Number of Participants With TEAEs Related to Physical Examination | Weight increased | 4 participants |
| Relugolix 80 mg | Number of Participants With TEAEs Related to Physical Examination | Ophthalmological examination abnormal | 1 participants |
| Relugolix 120 mg | Number of Participants With TEAEs Related to Physical Examination | Weight decreased | 0 participants |
| Relugolix 120 mg | Number of Participants With TEAEs Related to Physical Examination | Weight increased | 2 participants |
| Relugolix 120 mg | Number of Participants With TEAEs Related to Physical Examination | Ophthalmological examination abnormal | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAEs Related to Physical Examination | Weight increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAEs Related to Physical Examination | Ophthalmological examination abnormal | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With TEAEs Related to Physical Examination | Weight decreased | 2 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs
Vital signs included oral temperature, pulse rate, supine systolic and diastolic blood pressure, standing systolic and diastolic blood pressure, and weight. Any TEAEs that were associated with vital signs were reported.
Time frame: From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Syncope | 3 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Hypertension | 1 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Hypotension | 1 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Arrhythmia | 0 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Bradycardia | 2 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 1 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Heart rate irregular | 1 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Weight increased | 4 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Weight decreased | 1 participants |
| Relugolix 80 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 3 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Weight decreased | 0 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Syncope | 2 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 1 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Bradycardia | 0 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Hypertension | 4 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Weight increased | 2 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Hypotension | 2 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Heart rate irregular | 0 participants |
| Relugolix 120 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Arrhythmia | 1 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Weight increased | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Arrhythmia | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Bradycardia | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 1 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Weight decreased | 2 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Heart rate irregular | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Syncope | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Hypertension | 1 participants |
| Leuprorelin 22.5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs | Hypotension | 0 participants |
Secondary
Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks
PSA Response is defined as a reduction in PSA from Baseline and is reported for 2 categories: ≥ 50% reduction and ≥ 90% reduction.
Time frame: Week 5, Day 1
Population: Safety population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relugolix 80 mg | Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | ≥ 50% PSA reduction | 75 percentage of participants |
| Relugolix 80 mg | Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | ≥ 90% PSA reduction | 13 percentage of participants |
| Relugolix 120 mg | Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | ≥ 50% PSA reduction | 83 percentage of participants |
| Relugolix 120 mg | Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | ≥ 90% PSA reduction | 6 percentage of participants |
| Leuprorelin 22.5 mg | Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | ≥ 50% PSA reduction | 17 percentage of participants |
| Leuprorelin 22.5 mg | Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks | ≥ 90% PSA reduction | 0 percentage of participants |
Secondary
Percent Change From Baseline of Aging Male Survey (AMS) Total Score
AMS scale is a self-administered questionnaire used to: 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between 1=none to 5=extremely severe for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.
Time frame: Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix 80 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 5, Day 1 | 3.914 percent change | Standard Deviation 24.4749 |
| Relugolix 80 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 13, Day 1 | 14.781 percent change | Standard Deviation 24.0185 |
| Relugolix 80 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 25, Day 1 | 20.272 percent change | Standard Deviation 35.2952 |
| Relugolix 80 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 37, Day 1 | 24.136 percent change | Standard Deviation 33.8595 |
| Relugolix 80 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 49, Day 1 | 30.122 percent change | Standard Deviation 38.1093 |
| Relugolix 80 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | EOT | 18.857 percent change | Standard Deviation 37.926 |
| Relugolix 80 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Follow-Up | 15.754 percent change | Standard Deviation 21.8158 |
| Relugolix 80 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | End of Study | 16.270 percent change | Standard Deviation 24.2582 |
| Relugolix 120 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 25, Day 1 | 20.353 percent change | Standard Deviation 34.2105 |
| Relugolix 120 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Follow-Up | 13.031 percent change | Standard Deviation 33.7754 |
| Relugolix 120 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 37, Day 1 | 24.466 percent change | Standard Deviation 35.6742 |
| Relugolix 120 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 49, Day 1 | 24.377 percent change | Standard Deviation 33.6078 |
| Relugolix 120 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | EOT | 28.644 percent change | Standard Deviation 35.647 |
| Relugolix 120 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 5, Day 1 | 10.872 percent change | Standard Deviation 29.6532 |
| Relugolix 120 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 13, Day 1 | 17.259 percent change | Standard Deviation 33.9921 |
| Relugolix 120 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | End of Study | 21.304 percent change | Standard Deviation 46.0184 |
| Leuprorelin 22.5 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 25, Day 1 | 46.995 percent change | Standard Deviation 55.3558 |
| Leuprorelin 22.5 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 13, Day 1 | 21.887 percent change | Standard Deviation 36.5551 |
| Leuprorelin 22.5 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 5, Day 1 | 10.083 percent change | Standard Deviation 27.1933 |
| Leuprorelin 22.5 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 37, Day 1 | 49.422 percent change | Standard Deviation 61.1264 |
| Leuprorelin 22.5 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Follow-Up | 53.834 percent change | Standard Deviation 61.6683 |
| Leuprorelin 22.5 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | EOT | 60.952 percent change | Standard Deviation 63.3615 |
| Leuprorelin 22.5 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | Week 49, Day 1 | 59.971 percent change | Standard Deviation 60.3579 |
| Leuprorelin 22.5 mg | Percent Change From Baseline of Aging Male Survey (AMS) Total Score | End of Study | 49.879 percent change | Standard Deviation 54.154 |
Secondary
Prostate-Specific Antigen Nadir
PSA nadir is the lowest PSA achieved after treatment.
Time frame: During Weeks 1 to 24
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relugolix 80 mg | Prostate-Specific Antigen Nadir | 1.8 micrograms per liter (µg/L) | Standard Deviation 7.2 |
| Relugolix 120 mg | Prostate-Specific Antigen Nadir | 5.2 micrograms per liter (µg/L) | Standard Deviation 26.15 |
| Leuprorelin 22.5 mg | Prostate-Specific Antigen Nadir | 0.6 micrograms per liter (µg/L) | Standard Deviation 1.03 |
Secondary
Serum Follicle Stimulating Hormone (FSH) Concentrations
Blood was collected and serum concentrations of FSH were obtained using a validated laboratory test at a central laboratory facility.
Time frame: Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix 80 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 2, Day 1 | 3.112 IU/L | Standard Deviation 3.0612 |
| Relugolix 80 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 5, Day 1 | 1.248 IU/L | Standard Deviation 2.6737 |
| Relugolix 80 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 13, Day 1 | 1.137 IU/L | Standard Deviation 2.4242 |
| Relugolix 80 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 25, Day 1 | 1.090 IU/L | Standard Deviation 0.9932 |
| Relugolix 80 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 49, Day 1 | 1.802 IU/L | Standard Deviation 1.3956 |
| Relugolix 80 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | EOT | 5.377 IU/L | Standard Deviation 4.1261 |
| Relugolix 80 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Follow-Up | 16.160 IU/L | Standard Deviation 11.0517 |
| Relugolix 80 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | End of Study | 11.441 IU/L | Standard Deviation 8.7613 |
| Relugolix 120 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 13, Day 1 | 0.908 IU/L | Standard Deviation 0.8104 |
| Relugolix 120 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Follow-Up | 14.610 IU/L | Standard Deviation 6.1553 |
| Relugolix 120 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 25, Day 1 | 1.344 IU/L | Standard Deviation 0.9675 |
| Relugolix 120 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 49, Day 1 | 1.938 IU/L | Standard Deviation 1.2169 |
| Relugolix 120 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | EOT | 5.691 IU/L | Standard Deviation 2.9528 |
| Relugolix 120 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 2, Day 1 | 3.183 IU/L | Standard Deviation 2.8956 |
| Relugolix 120 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 5, Day 1 | 1.035 IU/L | Standard Deviation 1.0479 |
| Relugolix 120 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | End of Study | 15.768 IU/L | Standard Deviation 12.3329 |
| Leuprorelin 22.5 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 13, Day 1 | 4.625 IU/L | Standard Deviation 2.5594 |
| Leuprorelin 22.5 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 5, Day 1 | 2.946 IU/L | Standard Deviation 1.4428 |
| Leuprorelin 22.5 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 2, Day 1 | 7.650 IU/L | Standard Deviation 5.4542 |
| Leuprorelin 22.5 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 25, Day 1 | 5.043 IU/L | Standard Deviation 2.8221 |
| Leuprorelin 22.5 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Follow-Up | 9.200 IU/L | Standard Deviation 0 |
| Leuprorelin 22.5 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | EOT | 5.250 IU/L | Standard Deviation 3.0406 |
| Leuprorelin 22.5 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | Week 49, Day 1 | 5.145 IU/L | Standard Deviation 2.8201 |
| Leuprorelin 22.5 mg | Serum Follicle Stimulating Hormone (FSH) Concentrations | End of Study | 5.943 IU/L | Standard Deviation 3.6185 |
Secondary
Serum Luteinizing Hormone (LH) Concentrations
Blood was collected and serum concentrations of LH in milli international units per milliliters (mIU/mL) were obtained using a validated laboratory test at a central laboratory facility.
Time frame: Baseline and Day 4 of Week 1, Day 1 of Weeks 2, 3, 5,13, 25 and 49, End of Treatment (EOT - 106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | End of Study | 7.182 mIU/mL | Standard Deviation 8.0509 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 49, Day 1 | 0.341 mIU/mL | Standard Deviation 0.3948 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 13, Day 1 | 0.229 mIU/mL | Standard Deviation 0.6003 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | Follow-Up | 8.624 mIU/mL | Standard Deviation 5.3685 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 25, Day 1 | 0.195 mIU/mL | Standard Deviation 0.2524 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 2, Day 1 | 0.548 mIU/mL | Standard Deviation 0.6683 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 3, Day 1 | 0.341 mIU/mL | Standard Deviation 0.5851 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 1, Day 4 | 0.665 mIU/mL | Standard Deviation 0.6982 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | EOT | 3.189 mIU/mL | Standard Deviation 3.6928 |
| Relugolix 80 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 5, Day 1 | 0.424 mIU/mL | Standard Deviation 1.4941 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 2, Day 1 | 0.638 mIU/mL | Standard Deviation 1.3988 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 1, Day 4 | 0.595 mIU/mL | Standard Deviation 0.5467 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 3, Day 1 | 0.388 mIU/mL | Standard Deviation 0.7887 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 5, Day 1 | 0.203 mIU/mL | Standard Deviation 0.358 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 13, Day 1 | 0.183 mIU/mL | Standard Deviation 0.2542 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 25, Day 1 | 0.175 mIU/mL | Standard Deviation 0.1365 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 49, Day 1 | 0.288 mIU/mL | Standard Deviation 0.2479 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | EOT | 2.704 mIU/mL | Standard Deviation 2.5312 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | Follow-Up | 9.510 mIU/mL | Standard Deviation 5.2926 |
| Relugolix 120 mg | Serum Luteinizing Hormone (LH) Concentrations | End of Study | 9.306 mIU/mL | Standard Deviation 7.9054 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 49, Day 1 | 0.138 mIU/mL | Standard Deviation 0.1677 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 3, Day 1 | 3.171 mIU/mL | Standard Deviation 2.7636 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 2, Day 1 | 8.279 mIU/mL | Standard Deviation 5.8986 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | EOT | 0.585 mIU/mL | Standard Deviation 1.6775 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 1, Day 4 | 17.551 mIU/mL | Standard Deviation 13.1433 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 13, Day 1 | 0.277 mIU/mL | Standard Deviation 0.8253 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | End of Study | 1.394 mIU/mL | Standard Deviation 1.7702 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 25, Day 1 | 0.134 mIU/mL | Standard Deviation 0.0992 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | Week 5, Day 1 | 0.508 mIU/mL | Standard Deviation 0.4327 |
| Leuprorelin 22.5 mg | Serum Luteinizing Hormone (LH) Concentrations | Follow-Up | 0.525 mIU/mL | Standard Deviation 1.0187 |
Secondary
Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24
Blood was collected and serum concentrations of PSA were obtained using a validated laboratory test at a central laboratory facility.
Time frame: Day 1 of Weeks 13 and 25
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix 80 mg | Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Week 13, Day 1 | 2.651 μg/L | Standard Deviation 10.0624 |
| Relugolix 80 mg | Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Week 25, Day 1 | 1.936 μg/L | Standard Deviation 7.5731 |
| Relugolix 120 mg | Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Week 13, Day 1 | 5.786 μg/L | Standard Deviation 26.4243 |
| Relugolix 120 mg | Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Week 25, Day 1 | 2.360 μg/L | Standard Deviation 7.3103 |
| Leuprorelin 22.5 mg | Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Week 13, Day 1 | 0.916 μg/L | Standard Deviation 1.4478 |
| Leuprorelin 22.5 mg | Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24 | Week 25, Day 1 | 0.624 μg/L | Standard Deviation 1.0693 |
Secondary
Serum Sex Hormone-binding Globulin (SHBG) Concentrations
Blood was collected and serum concentrations of SHBG were obtained using a validated laboratory test at a central laboratory facility.
Time frame: Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)
Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix 80 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | EOT | 50.013 nanomoles per liter (nmol/L) | Standard Deviation 21.5189 |
| Relugolix 80 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 13, Day 1 | 49.210 nanomoles per liter (nmol/L) | Standard Deviation 19.3704 |
| Relugolix 80 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Follow-Up | 45.433 nanomoles per liter (nmol/L) | Standard Deviation 14.7416 |
| Relugolix 80 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | End of Study | 51.103 nanomoles per liter (nmol/L) | Standard Deviation 17.8497 |
| Relugolix 80 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 2, Day 1 | 50.811 nanomoles per liter (nmol/L) | Standard Deviation 15.8822 |
| Relugolix 80 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 5, Day 1 | 49.641 nanomoles per liter (nmol/L) | Standard Deviation 16.7048 |
| Relugolix 80 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 25, Day 1 | 47.998 nanomoles per liter (nmol/L) | Standard Deviation 18.869 |
| Relugolix 80 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 49, Day 1 | 50.607 nanomoles per liter (nmol/L) | Standard Deviation 18.0377 |
| Relugolix 120 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 49, Day 1 | 54.022 nanomoles per liter (nmol/L) | Standard Deviation 26.107 |
| Relugolix 120 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 2, Day 1 | 48.594 nanomoles per liter (nmol/L) | Standard Deviation 17.7492 |
| Relugolix 120 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 25, Day 1 | 50.774 nanomoles per liter (nmol/L) | Standard Deviation 23.3292 |
| Relugolix 120 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Follow-Up | 60.250 nanomoles per liter (nmol/L) | Standard Deviation 28.1206 |
| Relugolix 120 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 5, Day 1 | 49.185 nanomoles per liter (nmol/L) | Standard Deviation 21.1707 |
| Relugolix 120 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | End of Study | 51.063 nanomoles per liter (nmol/L) | Standard Deviation 23.1018 |
| Relugolix 120 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | EOT | 54.105 nanomoles per liter (nmol/L) | Standard Deviation 20.8439 |
| Relugolix 120 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 13, Day 1 | 50.538 nanomoles per liter (nmol/L) | Standard Deviation 23.2109 |
| Leuprorelin 22.5 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | End of Study | 39.014 nanomoles per liter (nmol/L) | Standard Deviation 13.1876 |
| Leuprorelin 22.5 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 2, Day 1 | 39.029 nanomoles per liter (nmol/L) | Standard Deviation 16.891 |
| Leuprorelin 22.5 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 5, Day 1 | 43.786 nanomoles per liter (nmol/L) | Standard Deviation 20.0484 |
| Leuprorelin 22.5 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 13, Day 1 | 41.858 nanomoles per liter (nmol/L) | Standard Deviation 18.1416 |
| Leuprorelin 22.5 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 25, Day 1 | 40.839 nanomoles per liter (nmol/L) | Standard Deviation 16.3732 |
| Leuprorelin 22.5 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | Week 49, Day 1 | 38.237 nanomoles per liter (nmol/L) | Standard Deviation 18.6708 |
| Leuprorelin 22.5 mg | Serum Sex Hormone-binding Globulin (SHBG) Concentrations | EOT | 23.000 nanomoles per liter (nmol/L) | Standard Deviation 0 |
Secondary
TAK-385 Plasma Concentrations
Time frame: Day 1 of Weeks 1, 2, 3, 5, 9, 13, 17, 25, 37, 49 pre-dose; Day 4 of Week 1 pre-dose; Day 1 of Weeks 5, 13, 2 hrs post-dose
Population: Safety population included all randomized participants who received at least 1 dose of study drug (TAK-835). Here 'n' is the number of participants analyzed at the specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 2, Day 1 pre-dose | 6.3 nanograms per milliliter (ng/mL) | Standard Deviation 6.32 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 13, Day 1 pre-dose | 5.5 nanograms per milliliter (ng/mL) | Standard Deviation 3.39 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 5, Day 1 pre-dose | 5.2 nanograms per milliliter (ng/mL) | Standard Deviation 2.79 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 13, Day 1, 2 hours post-dose | 24.1 nanograms per milliliter (ng/mL) | Standard Deviation 23.16 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 1, Day 4 pre-dose | 9.9 nanograms per milliliter (ng/mL) | Standard Deviation 13.63 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 17, Day 1 pre-dose | 6.3 nanograms per milliliter (ng/mL) | Standard Deviation 8.12 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 5, Day 1, 2 hours post-dose | 25.3 nanograms per milliliter (ng/mL) | Standard Deviation 21.76 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 25, Day 1 pre-dose | 7.3 nanograms per milliliter (ng/mL) | Standard Deviation 11.07 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 3, Day 1 pre-dose | 5.4 nanograms per milliliter (ng/mL) | Standard Deviation 3.24 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 37, Day 1 pre-dose | 6.3 nanograms per milliliter (ng/mL) | Standard Deviation 7.29 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 9, Day 1 pre-dose | 4.9 nanograms per milliliter (ng/mL) | Standard Deviation 3.47 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 49, Day 1 pre-dose | 5.9 nanograms per milliliter (ng/mL) | Standard Deviation 4.98 |
| Relugolix 80 mg | TAK-385 Plasma Concentrations | Week 1, Day 1 pre-dose | 0 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 49, Day 1 pre-dose | 9.4 nanograms per milliliter (ng/mL) | Standard Deviation 8.32 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 1, Day 1 pre-dose | 0 nanograms per milliliter (ng/mL) | Standard Deviation 0 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 1, Day 4 pre-dose | 14.2 nanograms per milliliter (ng/mL) | Standard Deviation 18.52 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 2, Day 1 pre-dose | 8.7 nanograms per milliliter (ng/mL) | Standard Deviation 10.1 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 3, Day 1 pre-dose | 10.3 nanograms per milliliter (ng/mL) | Standard Deviation 14.77 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 5, Day 1 pre-dose | 8.4 nanograms per milliliter (ng/mL) | Standard Deviation 9.85 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 5, Day 1, 2 hours post-dose | 45.4 nanograms per milliliter (ng/mL) | Standard Deviation 42.67 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 9, Day 1 pre-dose | 8.0 nanograms per milliliter (ng/mL) | Standard Deviation 5.82 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 13, Day 1 pre-dose | 9.0 nanograms per milliliter (ng/mL) | Standard Deviation 7.15 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 13, Day 1, 2 hours post-dose | 42.2 nanograms per milliliter (ng/mL) | Standard Deviation 37.04 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 17, Day 1 pre-dose | 8.9 nanograms per milliliter (ng/mL) | Standard Deviation 6.8 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 25, Day 1 pre-dose | 11.5 nanograms per milliliter (ng/mL) | Standard Deviation 14.15 |
| Relugolix 120 mg | TAK-385 Plasma Concentrations | Week 37, Day 1 pre-dose | 10.9 nanograms per milliliter (ng/mL) | Standard Deviation 16.94 |
Secondary
Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL
Time frame: During Weeks 1 to 24
Population: Safety population included all randomized participants who received at least 1 dose of study drug. If a participant has all post first dose testosterone measurements \>= 50 ng/dL, the participant's time to castration was censored at the last testosterone measurement that is \>= 50 ng/dL.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Relugolix 80 mg | Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | Time to Castration (< 50 ng/dL) | 4 days |
| Relugolix 80 mg | Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | Time to Profound Castration (< 20 ng/dL) | 15 days |
| Relugolix 120 mg | Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | Time to Castration (< 50 ng/dL) | 4 days |
| Relugolix 120 mg | Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | Time to Profound Castration (< 20 ng/dL) | 15 days |
| Leuprorelin 22.5 mg | Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | Time to Castration (< 50 ng/dL) | 29 days |
| Leuprorelin 22.5 mg | Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL | Time to Profound Castration (< 20 ng/dL) | 29 days |