Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134977
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Breast Cancer
Intervention Drug: Leuprorelin Acetate
Enrollment 2816
Recruitment Details Participants took part in the study in 351 investigative site in Japan from 21 September 2011 to 31 March 2015.
Pre-assignment Details Participants with a historical diagnosis of premenopausal breast cancer who were switched to leuprorelin acetate sustained-release 11.25 milligram (mg) injection kit from a 4-week adjuvant therapy with a luteinizing hormone-releasing hormone analog (LH-RHa) 1 month depot preparation as a part of daily medical practice were observed.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Period Title: Overall Study
Started 2816
Completed 2714
Not Completed 102
Reason Not Completed
Protocol Deviation             102
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Baseline Participants 2714
Hide Baseline Analysis Population Description
Safety analysis set was defined as participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2714 participants
43.5  (5.27)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 2714 participants
2714
Performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2714 participants
Grade 0 2686
Grade 1 28
[1]
Measure Description: Following are Eastern Cooperative Oncology Group (ECOG) grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of self-care, unable to carry out any work activities, up and about greater than (>)50% of waking hours. 3: Capable of limited self-care, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any self-care, totally confined to bed or chair.
Healthcare category   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2714 participants
Outpatient 2709
Inpatient 5
[1]
Measure Description: Participants were categorized as outpatient and inpatient.
Presence of Complications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2714 participants
Had no complications 2358
Had complications 355
Not determined 1
Number of Participants with Blood Estradiol Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2714 participants
>=30 picogram per milliliter (pg/mL) 219
Less than (<) 30 pg/mL 273
Not measured 2222
Blood Estradiol Level   [1] 
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 2714 participants
96.07  (192.148)
[1]
Measure Description: Only 492 participants had data available for blood estradiol levels.
Blood Follicle-Stimulating Hormone (FSH) Level  
Mean (Standard Deviation)
Unit of measure:  Milli-international units/milliliter
Number Analyzed 2714 participants
15.85  (24.712)
Time from surgery to the start of treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2714 participants
< 6 months 1434
Greater than or equal to (>=) 6 months to <1 year 596
>= 1 to <2 years 401
>= 2 years 272
Not determined 11
1.Primary Outcome
Title Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline
Hide Description QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2178
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total score (n=2174) 88.9  (11.11)
Daily activity (n=2178) 28.0  (3.05)
Physical condition (n=2178) 21.9  (2.75)
Psychological condition (n=2178) 19.1  (3.74)
Social relationships (n=2177) 16.0  (4.18)
2.Primary Outcome
Title QOL-ACD Total and Subscale Score at Week 12
Hide Description QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale:5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2035
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total score (n=2031) 88.7  (11.2)
Daily activity (n=2034) 27.9  (3.12)
Physical condition (n=2034) 21.8  (2.87)
Psychological condition (n=2035) 18.8  (3.81)
Social relationships (n=2034) 16.3  (4.15)
3.Primary Outcome
Title QOL-ACD Total and Subscale Score at Week 48
Hide Description QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 1662
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total score (n=1658) 89.9  (11.08)
Daily activity (n=1662) 28.1  (3.01)
Physical condition (n=1662) 22.2  (2.66)
Psychological condition (n=1662) 19.1  (3.71)
Social relationships (n=1662) 16.6  (4.10)
4.Primary Outcome
Title QOL-ACD Breast (QOL-ACD-B) Score at Baseline
Hide Description QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score was calculated over score range 0-100 for item 1 to 18 as ((a sum of 18 items)/18-1)*25). Score for physical condition and pain was calculated over score range 0-100 for item 1 to 6 as ((a sum of 6 items)/6-1)*25)). Score for health-care and illness satisfaction was calculated over score range 0-100 for item 7 to 10 as ((a sum of 4 items)/4-1)*25)), where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2176
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total score (n=2172) 70.4  (13.24)
Physical condition and pain (n=2175) 72.3  (17.41)
Health-care and illness satisfaction (n=2176) 85.1  (14.12)
5.Primary Outcome
Title Score of QOL-ACD-B at Week 12
Hide Description QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2031
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total score: (n=2025) 71.0  (13.36)
Physical condition and pain: (n=2031) 73.1  (17.71)
Health-care and illness satisfaction: (n=2029) 85.2  (14.76)
6.Primary Outcome
Title Score of QOL-ACD-B at Week 48
Hide Description QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 1659
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total score (n=1651) 71.9  (13.50)
Physical condition and pain (n=1659) 74.8  (17.34)
Healthcare and illness satisfaction (n=1656) 84.9  (14.89)
7.Primary Outcome
Title Score of QOL-ACD-B Items 19, 20 and 21 at Baseline
Hide Description QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where baseline assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: units on a scale
Item 19: (n=631) 3.3  (1.40)
Item 20: (n=624) 2.9  (1.43)
Item 21: (n=203) 1.7  (1.01)
8.Primary Outcome
Title Score of QOL-ACD-B Items 19, 20 and 21 at Week 12
Hide Description QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 12 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 574
Mean (Standard Deviation)
Unit of Measure: units on a scale
Item 19 (n=574) 3.5  (1.35)
Item 20 (n=566) 3.3  (1.40)
Item 21 (n=180) 1.8  (1.09)
9.Primary Outcome
Title Score of QOL-ACD-B Items 19, 20 and 21 at Week 48
Hide Description QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 443
Mean (Standard Deviation)
Unit of Measure: units on a scale
Item 19 (n=443) 3.5  (1.32)
Item 20 (n=441) 3.2  (1.35)
Item 21 (n=129) 1.7  (0.97)
10.Secondary Outcome
Title Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents
Hide Description The question was with regard to the assessment of convenience associated with the changes in agents, "Did the change in agents reduce the frequency of your medical visits?" and the answers were categorized as very much reduced, somewhat reduced, unchanged. Change in medicinal agents means participants with a historical diagnosis of premenopausal breast cancer who switched to leuprorelin acetate sustained-release 11.25 mg injection kit from a 4-week adjuvant therapy with a LH-RHa 1 month depot preparation as part of daily medical practice.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2396
Measure Type: Number
Unit of Measure: percentage of participants
Very much reduced 67.7
Somewhat reduced 10.1
Unchanged 16.9
Not determined 5.3
11.Secondary Outcome
Title Percentage of Participants Who Felt Relief From Physical and Emotional Burden
Hide Description The question was with regard to the assessment of convenience associated with the changes in agents, "The change in agents reduced the frequency of injections by one third; for this reason, did you feel relief from physical and emotional burden?" and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2396
Measure Type: Number
Unit of Measure: percentage of participants
Felt extreme relief 34.8
Felt slight relief 31.6
No feeling either way 17.8
Felt little relief 7.1
Felt no relief 4.8
Not determined 3.9
12.Secondary Outcome
Title Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents
Hide Description The question was with regard to the assessment of convenience associated with the changes in agents, "Did you feel relief from financial burden (example, 3 months' drug costs and transportation fee) due to the change in agents?" and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief. The sum of all the categories is not 100% because of rounding error.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2396
Measure Type: Number
Unit of Measure: percentage of participants
Felt extreme relief 22.2
Felt slight relief 41.0
No feeling either way 21.2
Felt little relief 9.5
Felt no relief 2.4
Not determined 3.6
13.Secondary Outcome
Title Percentage of Participants Who Worried About the Effect of the Medicinal Agent
Hide Description The question was with regard to the assessment of convenience associated with the changes in agents, "The change in agents reduced the frequency of injections by one third; for this reason, did you worry about the effect?" and the options of the answers were not at all worried, not too worried, no thought either way, somewhat worried, and very worried.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2396
Measure Type: Number
Unit of Measure: percentage of participants
Not at all worried 29.7
Not too worried 33.8
No thought either way 22.4
Somewhat worried 9.8
Very worried 0.8
Not determined 3.5
14.Secondary Outcome
Title Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents
Hide Description The question was with regard to the assessment of convenience associated with the changes in agents, "Was there a change in adverse drug reactions (e.g., menopausal-like symptoms such as hot flushes, injection-site abnormalities) due to the change in agents?" and the options of the answers were events became much less severe, events became less severe, whether or not the events became severe cannot be determined, events became slightly more severe, and events became very severe.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2396
Measure Type: Number
Unit of Measure: percentage of participants
Events became much less severe 1.4
Events became less severe 5.5
Cannot be determined 68.5
Events became slightly more severe 17.0
Events became very severe 3.9
Not determined 3.7
15.Secondary Outcome
Title Percentage of Participants With Change in Pain at the Time of Injection Due to the Change in Medicinal Agents
Hide Description The question was with regard to the assessment of convenience associated with the changes in agents, "Was there a change in pain at the time of injection due to the change in agents?" and the options of the answers were significantly relieved, slightly relieved, whether or not the pain worsened or was relieved cannot be determined, worsened slightly, and worsened significantly.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2396
Measure Type: Number
Unit of Measure: percentage of participants
Significantly relieved 4.7
Slightly relieved 10.4
Cannot be determined 64.9
Worsened slightly 14.4
Worsened significantly 2.1
Not determined 3.5
16.Secondary Outcome
Title Percentage of Participants With Positive Change in Agents
Hide Description The question was with regard to the assessment of convenience associated with the changes in agents, "Was the change in agents good?" and the options of the answers were very good, somewhat good, whether or not the change in agents was good cannot be determined, somewhat bad, very bad.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2396
Measure Type: Number
Unit of Measure: percentage of participants
Very good 32.0
Somewhat good 36.5
Cannot be determined 26.0
Somewhat bad 1.3
Very bad 0.5
Not determined 3.7
17.Secondary Outcome
Title Number of Participants Reporting One or More Adverse Drug Reactions
Hide Description Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was defined as participants who received at least one dose of study medication.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2714
Measure Type: Number
Unit of Measure: participants
427
18.Secondary Outcome
Title Number of Participants Reporting One or More Serious Adverse Drug Reactions
Hide Description Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event was occurred in breast cancer female.
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was defined as participants who received at least one dose of study medication.
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description:
Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
Overall Number of Participants Analyzed 2714
Measure Type: Number
Unit of Measure: participants
8
Time Frame Baseline up to week 48
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings. Only adverse drug reactions were collected in this study.
 
Arm/Group Title Leuprorelin Acetate
Hide Arm/Group Description Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
All-Cause Mortality
Leuprorelin Acetate
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Leuprorelin Acetate
Affected / at Risk (%)
Total   8/2714 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to lungs  1  1/2714 (0.04%) 
Metastases to bone  1  1/2714 (0.04%) 
Metastases to central nervous system  1  1/2714 (0.04%) 
Reproductive system and breast disorders   
Endometriosis  1  1/2714 (0.04%) 
Respiratory, thoracic and mediastinal disorders   
Radiation pneumonitis  1  2/2714 (0.07%) 
Interstitial lung disease  1  1/2714 (0.04%) 
Pulmonary embolism  1  1/2714 (0.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Leuprorelin Acetate
Affected / at Risk (%)
Total   239/2714 (8.81%) 
Vascular disorders   
Hot flush  1  239/2714 (8.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02134977    
Other Study ID Numbers: 265-211
JapicCTI-142513 ( Registry Identifier: JapicCTI )
First Submitted: April 23, 2014
First Posted: May 9, 2014
Results First Submitted: August 24, 2016
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016