Trial Outcomes & Findings for A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale (NCT NCT00394771)
NCT ID: NCT00394771
Last Updated: 2013-07-26
Results Overview
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
567 participants
Primary outcome timeframe
Day 1-84
Results posted on
2013-07-26
Participant Flow
A total of 988 subjects were screened for participation in this study, and 567 took at least one dose of investigational product (Safety population).
Participant milestones
| Measure |
Low Dose DR-1031
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
140
|
136
|
143
|
148
|
|
Overall Study
Intent to Treat (ITT) Population
|
110
|
110
|
108
|
120
|
|
Overall Study
COMPLETED
|
99
|
102
|
96
|
109
|
|
Overall Study
NOT COMPLETED
|
41
|
34
|
47
|
39
|
Reasons for withdrawal
| Measure |
Low Dose DR-1031
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Overall Study
Did not meet protocol requirements
|
1
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
4
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
10
|
6
|
8
|
12
|
|
Overall Study
Adverse Event
|
10
|
5
|
12
|
8
|
|
Overall Study
Participant pregnant
|
0
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
15
|
15
|
13
|
10
|
|
Overall Study
Other
|
3
|
3
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Baseline characteristics by cohort
| Measure |
Low Dose DR-1031
n=110 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=110 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
Total
n=448 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
30.1 years
STANDARD_DEVIATION 6.88 • n=5 Participants
|
30.5 years
STANDARD_DEVIATION 7.02 • n=7 Participants
|
30.7 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
30.6 years
STANDARD_DEVIATION 6.90 • n=4 Participants
|
30.5 years
STANDARD_DEVIATION 7.08 • n=21 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
448 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African-American
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
18 participants
n=5 Participants
|
17 participants
n=4 Participants
|
76 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
72 participants
n=5 Participants
|
68 participants
n=7 Participants
|
69 participants
n=5 Participants
|
82 participants
n=4 Participants
|
291 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
19 participants
n=5 Participants
|
16 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Weight
|
156.6 lbs
STANDARD_DEVIATION 28.84 • n=5 Participants
|
153.6 lbs
STANDARD_DEVIATION 27.18 • n=7 Participants
|
156.0 lbs
STANDARD_DEVIATION 30.79 • n=5 Participants
|
151.9 lbs
STANDARD_DEVIATION 30.03 • n=4 Participants
|
154.4 lbs
STANDARD_DEVIATION 29.22 • n=21 Participants
|
|
Body Mass Index
|
26.6 kg/m^2
STANDARD_DEVIATION 4.13 • n=5 Participants
|
25.7 kg/m^2
STANDARD_DEVIATION 4.24 • n=7 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 4.59 • n=5 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 4.41 • n=4 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 4.35 • n=21 Participants
|
|
Systolic Blood Pressure
|
114.2 mmHg
STANDARD_DEVIATION 10.74 • n=5 Participants
|
114.4 mmHg
STANDARD_DEVIATION 10.34 • n=7 Participants
|
115.6 mmHg
STANDARD_DEVIATION 9.31 • n=5 Participants
|
112.8 mmHg
STANDARD_DEVIATION 10.23 • n=4 Participants
|
114.2 mmHg
STANDARD_DEVIATION 10.19 • n=21 Participants
|
|
Diastolic Blood Pressure
|
72.3 mmHg
STANDARD_DEVIATION 8.85 • n=5 Participants
|
72.9 mmHg
STANDARD_DEVIATION 7.46 • n=7 Participants
|
71.8 mmHg
STANDARD_DEVIATION 7.72 • n=5 Participants
|
71.4 mmHg
STANDARD_DEVIATION 8.44 • n=4 Participants
|
72.1 mmHg
STANDARD_DEVIATION 8.14 • n=21 Participants
|
|
Heart Rate
|
73.9 beats/minute
STANDARD_DEVIATION 9.85 • n=5 Participants
|
73.7 beats/minute
STANDARD_DEVIATION 8.90 • n=7 Participants
|
73.7 beats/minute
STANDARD_DEVIATION 9.17 • n=5 Participants
|
71.9 beats/minute
STANDARD_DEVIATION 9.07 • n=4 Participants
|
73.3 beats/minute
STANDARD_DEVIATION 9.26 • n=21 Participants
|
|
Smoking Status
Current Smoker
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
Smoking Status
Past Smoker
|
20 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
21 participants
n=4 Participants
|
64 participants
n=21 Participants
|
|
Smoking Status
Non-Smoker
|
77 participants
n=5 Participants
|
83 participants
n=7 Participants
|
85 participants
n=5 Participants
|
88 participants
n=4 Participants
|
333 participants
n=21 Participants
|
|
Oral Contraceptive Use History
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Oral Contraceptive Use History
Continuous User
|
44 participants
n=5 Participants
|
46 participants
n=7 Participants
|
42 participants
n=5 Participants
|
49 participants
n=4 Participants
|
181 participants
n=21 Participants
|
|
Oral Contraceptive Use History
Prior User
|
44 participants
n=5 Participants
|
45 participants
n=7 Participants
|
49 participants
n=5 Participants
|
52 participants
n=4 Participants
|
190 participants
n=21 Participants
|
|
Oral Contraceptive Use History
Fresh-Start
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
17 participants
n=5 Participants
|
19 participants
n=4 Participants
|
76 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1-84Population: Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Outcome measures
| Measure |
Low Dose DR-1031
n=110 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=110 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
|
13 days
Interval 0.0 to 67.0
|
13.5 days
Interval 0.0 to 65.0
|
15 days
Interval 0.0 to 69.0
|
15 days
Interval 0.0 to 56.0
|
PRIMARY outcome
Timeframe: Day 92-176Population: Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Outcome measures
| Measure |
Low Dose DR-1031
n=109 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=107 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)
|
6 days
Interval 0.0 to 74.0
|
7 days
Interval 0.0 to 70.0
|
5 days
Interval 0.0 to 74.0
|
6 days
Interval 0.0 to 55.0
|
SECONDARY outcome
Timeframe: Day 1-84Population: Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.
Bleeding is defined as a flow heavy enough to require sanitary protection.
Outcome measures
| Measure |
Low Dose DR-1031
n=110 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=110 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Days With Bleeding During Active Cycle 1 (Day 1-84)
|
3.5 days
Interval 0.0 to 24.0
|
2.5 days
Interval 0.0 to 49.0
|
4 days
Interval 0.0 to 47.0
|
2 days
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 92-176Population: Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.
Bleeding is defined as a flow heavy enough to require sanitary protection.
Outcome measures
| Measure |
Low Dose DR-1031
n=109 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=107 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Days With Bleeding During Active Cycle 2 (Day 92-176)
|
1 days
Interval 0.0 to 24.0
|
2 days
Interval 0.0 to 49.0
|
1 days
Interval 0.0 to 27.0
|
2 days
Interval 0.0 to 23.0
|
SECONDARY outcome
Timeframe: Day 1-84Population: ITT population. However this data was not summarized due to limitations in the diary data.
Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection. Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1-84Population: ITT population. However data was not summarized due to limitations in the diary data.
Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy. Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity. See pre-specified analyses for Number of Moderate to Heavy Bleeding Days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 85-91Population: Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.
Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.
Outcome measures
| Measure |
Low Dose DR-1031
n=109 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=106 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)
0 day
|
14 participants
|
28 participants
|
25 participants
|
27 participants
|
|
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)
1-3 days
|
36 participants
|
17 participants
|
27 participants
|
18 participants
|
|
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)
4-7 days
|
59 participants
|
63 participants
|
54 participants
|
75 participants
|
SECONDARY outcome
Timeframe: Day 177-183Population: Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.
Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.
Outcome measures
| Measure |
Low Dose DR-1031
n=97 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=96 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=94 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=105 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)
0 day
|
15 participants
|
20 participants
|
23 participants
|
21 participants
|
|
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)
1-3 days
|
32 participants
|
32 participants
|
26 participants
|
24 participants
|
|
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)
4-7 days
|
50 participants
|
44 participants
|
45 participants
|
60 participants
|
SECONDARY outcome
Timeframe: Day 1-84Population: Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Outcome measures
| Measure |
Low Dose DR-1031
n=110 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=110 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Breast tenderness/pain
|
58 participants
|
57 participants
|
50 participants
|
64 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Headache
|
83 participants
|
84 participants
|
86 participants
|
92 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Bloating
|
80 participants
|
76 participants
|
72 participants
|
84 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Pelvic pain
|
72 participants
|
65 participants
|
61 participants
|
67 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Anxiety
|
42 participants
|
43 participants
|
34 participants
|
59 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Depression
|
51 participants
|
40 participants
|
36 participants
|
52 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Irritability
|
72 participants
|
69 participants
|
66 participants
|
78 participants
|
SECONDARY outcome
Timeframe: Day 92-176Population: Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Outcome measures
| Measure |
Low Dose DR-1031
n=109 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=107 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Breast tenderness/pain
|
46 participants
|
47 participants
|
44 participants
|
44 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Headache
|
74 participants
|
72 participants
|
72 participants
|
78 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Bloating
|
64 participants
|
64 participants
|
57 participants
|
70 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Pelvic pain
|
58 participants
|
57 participants
|
45 participants
|
57 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Anxiety
|
40 participants
|
40 participants
|
31 participants
|
47 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Depression
|
41 participants
|
39 participants
|
30 participants
|
44 participants
|
|
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Irritability
|
55 participants
|
63 participants
|
54 participants
|
65 participants
|
SECONDARY outcome
Timeframe: Day 85-91Population: Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Outcome measures
| Measure |
Low Dose DR-1031
n=110 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=110 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Headache
|
57 participants
|
50 participants
|
57 participants
|
50 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Bloating
|
61 participants
|
51 participants
|
46 participants
|
62 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Pelvic pain
|
50 participants
|
49 participants
|
37 participants
|
53 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Anxiety
|
26 participants
|
17 participants
|
14 participants
|
22 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Depression
|
25 participants
|
21 participants
|
17 participants
|
23 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Irritability
|
44 participants
|
43 participants
|
23 participants
|
36 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Breast tenderness/pain
|
33 participants
|
28 participants
|
17 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Day 177-183Population: Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Outcome measures
| Measure |
Low Dose DR-1031
n=97 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=96 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=94 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=105 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Breast tenderness/pain
|
29 participants
|
25 participants
|
15 participants
|
25 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Headache
|
39 participants
|
42 participants
|
37 participants
|
48 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Bloating
|
51 participants
|
53 participants
|
38 participants
|
60 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Pelvic pain
|
52 participants
|
42 participants
|
31 participants
|
51 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Anxiety
|
21 participants
|
22 participants
|
13 participants
|
22 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Depression
|
18 participants
|
21 participants
|
15 participants
|
17 participants
|
|
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Irritability
|
39 participants
|
37 participants
|
25 participants
|
39 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1-84Population: Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.
Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.
Outcome measures
| Measure |
Low Dose DR-1031
n=110 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=110 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)
|
0 days
Interval 0.0 to 12.0
|
0 days
Interval 0.0 to 19.0
|
0 days
Interval 0.0 to 16.0
|
0 days
Interval 0.0 to 21.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 92-176Population: Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.
Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.
Outcome measures
| Measure |
Low Dose DR-1031
n=109 Participants
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=108 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=107 Participants
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=120 Participants
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)
|
0 days
Interval 0.0 to 11.0
|
0 days
Interval 0.0 to 13.0
|
0 days
Interval 0.0 to 8.0
|
0 days
Interval 0.0 to 7.0
|
Adverse Events
Low Dose DR-1031
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Midrange Dose DR-1031
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
High Dose DR-1031
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Seasonale
Serious events: 5 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose DR-1031
n=140 participants at risk
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=136 participants at risk
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=143 participants at risk
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=148 participants at risk
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.68%
1/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.68%
1/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.74%
1/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.74%
1/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
1.4%
2/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.68%
1/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Injury, poisoning and procedural complications
Polytraumatism
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.68%
1/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.74%
1/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.70%
1/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Nervous system disorders
Hemiparesis
|
0.71%
1/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Nervous system disorders
Hypoaesthesia
|
0.71%
1/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.68%
1/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
1.4%
2/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.00%
0/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
Other adverse events
| Measure |
Low Dose DR-1031
n=140 participants at risk
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Midrange Dose DR-1031
n=136 participants at risk
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
High Dose DR-1031
n=143 participants at risk
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Seasonale
n=148 participants at risk
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
13.6%
19/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
14.0%
19/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
16.1%
23/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
12.8%
19/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Nervous system disorders
Migraine
|
1.4%
2/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
5.1%
7/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.70%
1/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
1.4%
2/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
15/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
5.1%
7/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
5.6%
8/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
5.4%
8/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
9/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
5.1%
7/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
3.5%
5/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
6.1%
9/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Infections and infestations
Sinusitis
|
7.1%
10/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
4.4%
6/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
1.4%
2/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
4.1%
6/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Infections and infestations
Urinary tract infection
|
5.7%
8/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
0.74%
1/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
3.5%
5/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
1.4%
2/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
9.3%
13/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
4.4%
6/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
3.5%
5/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
4.7%
7/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Investigations
Weight increased
|
4.3%
6/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
2.9%
4/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
6.3%
9/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
5.4%
8/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
7/140 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
5.1%
7/136 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
3.5%
5/143 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
4.1%
6/148 • Day 1 up to Day 256 (longest treatment plus 14 days)
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Details of the study and its results shall not be publicized or published in any form to cooperative publication without prior, written consent of sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.
- Publication restrictions are in place
Restriction type: OTHER