Trial Outcomes & Findings for LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study (NCT NCT01254292)
NCT ID: NCT01254292
Last Updated: 2017-09-25
Results Overview
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.
COMPLETED
PHASE3
567 participants
At 18 months
2017-09-25
Participant Flow
The study was conducted in 42 centers across 4 countries in Austria, Belgium, Germany and United States.
644 subjects were screened, of which 77 were screen failures and 567 were randomized, 282 subjects to LCS12 and 285 subjects to Yasmin. 279 subjects randomized to LCS12 while 281 subjects randomized to Yasmin received treatment and started comparative phase up to 18 months. 200 subjects randomized to LCS12 entered extension phase up to 36 months.
Participant milestones
| Measure |
LCS12 (Skyla, BAY86-5028)
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
|---|---|---|
|
Comparative Phase
STARTED
|
282
|
285
|
|
Comparative Phase
Participants Received Treatment
|
279
|
281
|
|
Comparative Phase
COMPLETED
|
227
|
204
|
|
Comparative Phase
NOT COMPLETED
|
55
|
81
|
|
LCS12 Extension Phase
STARTED
|
200
|
0
|
|
LCS12 Extension Phase
COMPLETED
|
163
|
0
|
|
LCS12 Extension Phase
NOT COMPLETED
|
37
|
0
|
Reasons for withdrawal
| Measure |
LCS12 (Skyla, BAY86-5028)
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
|---|---|---|
|
Comparative Phase
Adverse Event
|
25
|
25
|
|
Comparative Phase
Lost to Follow-up
|
3
|
21
|
|
Comparative Phase
Pregnancy
|
2
|
6
|
|
Comparative Phase
Withdrawal by Subject
|
20
|
21
|
|
Comparative Phase
Protocol Violation
|
1
|
2
|
|
Comparative Phase
Wish for pregnancy
|
4
|
6
|
|
LCS12 Extension Phase
Wish for pregnancy
|
14
|
0
|
|
LCS12 Extension Phase
Adverse Event
|
9
|
0
|
|
LCS12 Extension Phase
Withdrawal by Subject
|
7
|
0
|
|
LCS12 Extension Phase
Other unknown
|
4
|
0
|
|
LCS12 Extension Phase
Pregnancy
|
2
|
0
|
|
LCS12 Extension Phase
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
Baseline characteristics by cohort
| Measure |
LCS12 (Skyla, BAY86-5028)
n=279 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
EE30/DRSP (Yasmin, BAY86-5131)
n=281 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
Total
n=560 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.7 Years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
23.9 Years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
23.8 Years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
279 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
560 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Number of births
0
|
216 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
|
Number of births
1
|
39 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Number of births
2
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Number of births
3
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Number of births
4
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 18 monthsPopulation: Full analysis set (only subjects with at least one assessment of the overall satisfaction rating)
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=260 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=274 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)
|
81.9 Percentage of participants
|
82.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months)
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=260 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=273 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Overall Satisfaction Rating by the 5-point Likert Item at 6 Months
Very Satisfied
|
48.1 Percentage of participants
|
60.4 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 6 Months
Satisfied
|
35.8 Percentage of participants
|
27.5 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 6 Months
Neither satisfied nor dissatisfied
|
9.6 Percentage of participants
|
7.3 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 6 Months
Dissatisfied
|
6.2 Percentage of participants
|
1.8 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 6 Months
Very Dissatisfied
|
0.4 Percentage of participants
|
2.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=238 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=253 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Overall Satisfaction Rating by the 5-point Likert Item at 12 Months
Very Satisfied
|
45.0 Percentage of participants
|
66.8 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 12 Months
Satisfied
|
44.1 Percentage of participants
|
22.9 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 12 Months
Neither satisfied nor dissatisfied
|
5.9 Percentage of participants
|
5.9 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 12 Months
Dissatisfied
|
3.8 Percentage of participants
|
4.3 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 12 Months
Very Dissatisfied
|
1.3 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At 18 monthsPopulation: Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months)
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=217 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=235 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Overall Satisfaction Rating by the 5-point Likert Item at 18 Months
Very Satisfied
|
52.5 Percentage of participants
|
64.3 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 18 Months
Satisfied
|
37.8 Percentage of participants
|
25.1 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 18 Months
Neither satisfied nor dissatisfied
|
6.9 Percentage of participants
|
6.4 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 18 Months
Dissatisfied
|
2.8 Percentage of participants
|
3.0 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at 18 Months
Very Dissatisfied
|
0.0 Percentage of participants
|
1.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study)
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=251 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=268 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)
Very Satisfied
|
46.6 Percentage of participants
|
58.6 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)
Satisfied
|
35.1 Percentage of participants
|
23.5 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)
Neither satisfied nor dissatisfied
|
9.6 Percentage of participants
|
8.6 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)
Dissatisfied
|
7.6 Percentage of participants
|
5.6 Percentage of participants
|
|
Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)
Very Dissatisfied
|
1.2 Percentage of participants
|
3.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before)
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=260 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=273 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Overall Satisfaction Rate at 6 Months (LOCF)
|
83.8 Percentage of participants
|
87.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)
Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=260 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=274 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Overall Satisfaction Rate at 12 Months (LOCF)
|
83.8 Percentage of participants
|
84.3 Percentage of participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=250 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=263 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Acc. without inconvenience/discomfort
|
186 Participants
|
153 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Acc. with some inconv/discomfort
|
46 Participants
|
87 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Not acc. with moderate inconv./discomf.
|
15 Participants
|
11 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Not acc. with extreme inconv./discomf
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=248 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=263 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Choices Upon Completion of the Study
Continue with study treatment
|
122 Participants
|
174 Participants
|
|
User Satisfaction - Choices Upon Completion of the Study
Use a different hormonal contraceptive
|
51 Participants
|
34 Participants
|
|
User Satisfaction - Choices Upon Completion of the Study
Use a different contraceptive method
|
27 Participants
|
17 Participants
|
|
User Satisfaction - Choices Upon Completion of the Study
Discont. use of all types of contracept.
|
14 Participants
|
6 Participants
|
|
User Satisfaction - Choices Upon Completion of the Study
No need for contraceptive at this time
|
12 Participants
|
5 Participants
|
|
User Satisfaction - Choices Upon Completion of the Study
Undecided
|
22 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=250 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=260 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Amount of Menstrual Bleeding
Decreased
|
35 Participants
|
80 Participants
|
|
User Satisfaction - Amount of Menstrual Bleeding
Not Changed
|
207 Participants
|
163 Participants
|
|
User Satisfaction - Amount of Menstrual Bleeding
Increased
|
8 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=250 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=263 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Pattern
Very satisfied
|
91 Participants
|
101 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Pattern
Somewhat satisfied
|
84 Participants
|
65 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Pattern
Neither satisfied nor dissatisfied
|
68 Participants
|
48 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Pattern
Dissatisfied
|
4 Participants
|
19 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Pattern
Very dissatisfied
|
1 Participants
|
10 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Pattern
Not applicable
|
2 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=250 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=263 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Frequency of Experiencing Unexpected Bleeding
Never
|
219 Participants
|
145 Participants
|
|
User Satisfaction - Frequency of Experiencing Unexpected Bleeding
Seldom
|
25 Participants
|
92 Participants
|
|
User Satisfaction - Frequency of Experiencing Unexpected Bleeding
Often
|
5 Participants
|
17 Participants
|
|
User Satisfaction - Frequency of Experiencing Unexpected Bleeding
Very Often
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=14 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=130 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Absence
Very satisfied
|
6 Participants
|
96 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Absence
Somewhat satisfied
|
0 Participants
|
18 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Absence
Neither satisfied nor dissatisfied
|
8 Participants
|
14 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Absence
Dissatisfied
|
0 Participants
|
1 Participants
|
|
User Satisfaction - Satisfaction With Menstrual Bleeding Absence
Very dissatisfied
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=247 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=259 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment
Decreased
|
61 Participants
|
118 Participants
|
|
User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment
Not changed
|
169 Participants
|
102 Participants
|
|
User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment
Increased
|
17 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=249 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=261 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Rating of Usual Menstrual Pain Intensity
None
|
82 Participants
|
124 Participants
|
|
User Satisfaction - Rating of Usual Menstrual Pain Intensity
Mild
|
92 Participants
|
78 Participants
|
|
User Satisfaction - Rating of Usual Menstrual Pain Intensity
Moderate
|
67 Participants
|
43 Participants
|
|
User Satisfaction - Rating of Usual Menstrual Pain Intensity
Severe
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At screeningPopulation: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated)
The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=275 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=273 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
EVAPIL-R Scores at Screening - Composite Score
|
0.8846 Scores on a scale
Standard Deviation 0.8231
|
0.9386 Scores on a scale
Standard Deviation 0.8036
|
SECONDARY outcome
Timeframe: At screeningPopulation: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated)
The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=276 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=273 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
EVAPIL-R Scores at Screening - Bother Score
|
0.5188 Scores on a scale
Standard Deviation 0.4406
|
0.5569 Scores on a scale
Standard Deviation 0.4451
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated)
The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=243 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=252 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
EVAPIL-R Scores at 6 Months
Composite score
|
1.1537 Scores on a scale
Standard Deviation 0.9947
|
1.3187 Scores on a scale
Standard Deviation 0.9888
|
|
EVAPIL-R Scores at 6 Months
Bother score
|
0.6550 Scores on a scale
Standard Deviation 0.5148
|
0.7364 Scores on a scale
Standard Deviation 0.4940
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated)
The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=218 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=233 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
EVAPIL-R Scores at 12 Months - Bother Score
|
0.6015 Scores on a scale
Standard Deviation 0.4663
|
0.7789 Scores on a scale
Standard Deviation 0.5120
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated)
The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=218 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=229 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
EVAPIL-R Scores at 12 Months - Composite Score
|
1.0535 Scores on a scale
Standard Deviation 0.8698
|
1.4022 Scores on a scale
Standard Deviation 1.0126
|
SECONDARY outcome
Timeframe: At 18 months/EOSPopulation: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 18 months/end of study where the scores could be calculated)
The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=250 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=260 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
EVAPIL-R Scores at 18 Months/EOS
Composite score
|
1.0246 Scores on a scale
Standard Deviation 0.9546
|
1.4804 Scores on a scale
Standard Deviation 1.1926
|
|
EVAPIL-R Scores at 18 Months/EOS
Bother score
|
0.5908 Scores on a scale
Standard Deviation 0.4836
|
0.8113 Scores on a scale
Standard Deviation 0.5765
|
SECONDARY outcome
Timeframe: Up to 6, 12, 18, 24 and 36 monthsPopulation: Full analysis set
The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=281 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=279 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Cumulative Drop-out Rate
Up to 6 months
|
11.39 Percentage of participants
|
7.53 Percentage of participants
|
|
Cumulative Drop-out Rate
Up to 12 months
|
21.71 Percentage of participants
|
13.26 Percentage of participants
|
|
Cumulative Drop-out Rate
Up to 18 months
|
27.40 Percentage of participants
|
18.64 Percentage of participants
|
|
Cumulative Drop-out Rate
Up to 24 months
|
NA Percentage of participants
Extension phase was only for LCS12 group
|
30.85 Percentage of participants
|
|
Cumulative Drop-out Rate
Up to 36 months
|
NA Percentage of participants
Extension phase was only for LCS12 group
|
33.34 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 18, 24, 36 monthsPopulation: Full analysis set
The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=281 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=279 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Pearl Index (PI)
Pearl index up to 18 months
|
1.82 Pregnancies per 100 women years
Interval 0.67 to 3.97
|
0.57 Pregnancies per 100 women years
Interval 0.07 to 2.05
|
|
Pearl Index (PI)
Pearl index up to 24 months
|
NA Pregnancies per 100 women years
Extension phase was only for LCS12 group.
|
0.67 Pregnancies per 100 women years
Interval 0.14 to 1.95
|
|
Pearl Index (PI)
Pearl index up to 36 months
|
NA Pregnancies per 100 women years
Extension phase was only for LCS12 group.
|
0.65 Pregnancies per 100 women years
Interval 0.18 to 1.67
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Full analysis set
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=281 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Compliance Rate for Yasmin Pill Intake
Missing
|
—
|
2.8 Percentage of participants
|
|
Compliance Rate for Yasmin Pill Intake
Compliance <=75%
|
—
|
2.1 Percentage of participants
|
|
Compliance Rate for Yasmin Pill Intake
Compliance >75%
|
—
|
95.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 6 months)
The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=244 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=256 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Acc. without inconvenience/discomfort
|
192 Participants
|
163 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Acc. with some inconv/discomfort
|
48 Participants
|
87 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Not acc. with moderate inconv./discomf.
|
4 Participants
|
4 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Not acc. with extreme inconv./discomf.
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 12 months)
The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
n=220 Participants
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=237 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Acc. without inconvenience/discomfort
|
185 Participants
|
152 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Acc. with some inconv/discomfort
|
33 Participants
|
74 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Not acc. with moderate inconv./discomf.
|
2 Participants
|
9 Participants
|
|
User Satisfaction - Acceptability of the Administration of Study Treatment
Not acc. with extreme inconv./discomf.
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18, 24, 36 monthsPopulation: Full analysis set
Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=279 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Cumulative Number of Participants With Partial or Total Expulsion
Partial expulsion up to 18 months
|
—
|
0 Participants
|
|
Cumulative Number of Participants With Partial or Total Expulsion
Total expulsion up to 18 months
|
—
|
0 Participants
|
|
Cumulative Number of Participants With Partial or Total Expulsion
Partial expulsion up to 24 months
|
—
|
1 Participants
|
|
Cumulative Number of Participants With Partial or Total Expulsion
Total expulsion up to 24 months
|
—
|
0 Participants
|
|
Cumulative Number of Participants With Partial or Total Expulsion
Partial expulsion up to 36 months
|
—
|
1 Participants
|
|
Cumulative Number of Participants With Partial or Total Expulsion
Total expulsion up to 36 months
|
—
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 monthsPopulation: Full analysis set
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=279 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Investigator's Evaluation of Successful IUS Insertion Procedure
Easy
|
—
|
247 Participants
|
|
Investigator's Evaluation of Successful IUS Insertion Procedure
Slightly difficult
|
—
|
31 Participants
|
|
Investigator's Evaluation of Successful IUS Insertion Procedure
Very difficult
|
—
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 monthsPopulation: Full analysis set
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=279 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Participants' Evaluation of Pain During Successful IUS Insertion Procedure
Severe
|
—
|
25 Participants
|
|
Participants' Evaluation of Pain During Successful IUS Insertion Procedure
None
|
—
|
49 Participants
|
|
Participants' Evaluation of Pain During Successful IUS Insertion Procedure
Mild
|
—
|
125 Participants
|
|
Participants' Evaluation of Pain During Successful IUS Insertion Procedure
Moderate
|
—
|
80 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36 monthsPopulation: Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=267 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Investigator's Evaluation of IUS Removal Procedure
Easy
|
—
|
252 Participants
|
|
Investigator's Evaluation of IUS Removal Procedure
Slightly difficult
|
—
|
11 Participants
|
|
Investigator's Evaluation of IUS Removal Procedure
Very difficult
|
—
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36 monthsPopulation: Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)
Outcome measures
| Measure |
EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
LCS12 (Skyla, BAY86-5028)
n=267 Participants
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
|---|---|---|
|
Participants' Evaluation of Pain During IUS Removal Procedure
None
|
—
|
136 Participants
|
|
Participants' Evaluation of Pain During IUS Removal Procedure
Mild
|
—
|
96 Participants
|
|
Participants' Evaluation of Pain During IUS Removal Procedure
Moderate
|
—
|
30 Participants
|
|
Participants' Evaluation of Pain During IUS Removal Procedure
Severe
|
—
|
5 Participants
|
Adverse Events
LCS12 (Skyla, BAY86-5028)
EE30/DRSP (Yasmin, BAY86-5131)
Serious adverse events
| Measure |
LCS12 (Skyla, BAY86-5028)
n=279 participants at risk
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
EE30/DRSP (Yasmin, BAY86-5131)
n=281 participants at risk
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
|---|---|---|
|
Endocrine disorders
Basedow's disease
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
General disorders
Impaired healing
|
0.00%
0/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Appendicitis
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.71%
2/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.72%
2/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Musculoskeletal and connective tissue disorders
Nose deformity
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Breast abscess
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline ovarian tumour
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Surgical and medical procedures
Breast prosthesis implantation
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Surgical and medical procedures
Myomectomy
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Surgical and medical procedures
Mammoplasty
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
Other adverse events
| Measure |
LCS12 (Skyla, BAY86-5028)
n=279 participants at risk
Participants received LCS12 (low dose levonorgestrel \[LNG\] intrauterine delivery system \[IUS\]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
|
EE30/DRSP (Yasmin, BAY86-5131)
n=281 participants at risk
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.71%
2/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
21/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.3%
12/279 • From start of treatment until 36 months/EOS visit.
|
1.8%
5/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
2.1%
6/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
3.2%
9/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
9/279 • From start of treatment until 36 months/EOS visit.
|
5.0%
14/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
0.71%
2/281 • From start of treatment until 36 months/EOS visit.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
2.8%
8/281 • From start of treatment until 36 months/EOS visit.
|
|
General disorders
Irritability
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
General disorders
Pyrexia
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.71%
2/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Acute tonsillitis
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
2.1%
6/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Bronchitis
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Cystitis
|
8.2%
23/279 • From start of treatment until 36 months/EOS visit.
|
5.3%
15/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Influenza
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
22/279 • From start of treatment until 36 months/EOS visit.
|
4.6%
13/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Sinusitis
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
2.1%
6/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Tonsillitis
|
2.5%
7/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
14/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vaginal infection
|
3.9%
11/279 • From start of treatment until 36 months/EOS visit.
|
2.5%
7/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vulvitis
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.4%
15/279 • From start of treatment until 36 months/EOS visit.
|
2.1%
6/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vulvovaginitis
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vaginitis bacterial
|
3.2%
9/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
3.6%
10/279 • From start of treatment until 36 months/EOS visit.
|
2.5%
7/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vulvovaginitis streptococcal
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.6%
10/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Investigations
Smear cervix abnormal
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Investigations
Weight decreased
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Investigations
Weight increased
|
3.6%
10/279 • From start of treatment until 36 months/EOS visit.
|
2.8%
8/281 • From start of treatment until 36 months/EOS visit.
|
|
Investigations
Human papilloma virus test positive
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
8/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Nervous system disorders
Headache
|
9.3%
26/279 • From start of treatment until 36 months/EOS visit.
|
11.4%
32/281 • From start of treatment until 36 months/EOS visit.
|
|
Nervous system disorders
Migraine
|
0.72%
2/279 • From start of treatment until 36 months/EOS visit.
|
1.8%
5/281 • From start of treatment until 36 months/EOS visit.
|
|
Psychiatric disorders
Depression
|
0.72%
2/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/279 • From start of treatment until 36 months/EOS visit.
|
1.4%
4/281 • From start of treatment until 36 months/EOS visit.
|
|
Psychiatric disorders
Libido decreased
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Psychiatric disorders
Mood altered
|
0.36%
1/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Breast pain
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.71%
2/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
12.5%
35/279 • From start of treatment until 36 months/EOS visit.
|
5.7%
16/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
16.8%
47/279 • From start of treatment until 36 months/EOS visit.
|
9.3%
26/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.2%
6/279 • From start of treatment until 36 months/EOS visit.
|
1.8%
5/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
3.6%
10/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
6.5%
18/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.7%
13/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.3%
12/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.9%
8/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
2.2%
6/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Coital bleeding
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.72%
2/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
7/279 • From start of treatment until 36 months/EOS visit.
|
0.71%
2/281 • From start of treatment until 36 months/EOS visit.
|
|
Skin and subcutaneous tissue disorders
Acne
|
12.2%
34/279 • From start of treatment until 36 months/EOS visit.
|
2.1%
6/281 • From start of treatment until 36 months/EOS visit.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
1.8%
5/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Bacterial vaginosis
|
6.5%
18/279 • From start of treatment until 36 months/EOS visit.
|
1.1%
3/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Ear infection
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Gonorrhoea
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vaginitis gardnerella
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Chlamydial infection
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Vaginitis chlamydial
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Infections and infestations
Candida infection
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
0.71%
2/281 • From start of treatment until 36 months/EOS visit.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Investigations
Chlamydia test positive
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
0.71%
2/281 • From start of treatment until 36 months/EOS visit.
|
|
Psychiatric disorders
Irritability
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Dyspareunia
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
1.4%
4/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.36%
1/281 • From start of treatment until 36 months/EOS visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
3/279 • From start of treatment until 36 months/EOS visit.
|
0.00%
0/281 • From start of treatment until 36 months/EOS visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60