Trial Outcomes & Findings for Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS) (NCT NCT00360490)
NCT ID: NCT00360490
Last Updated: 2013-12-09
Results Overview
The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.
COMPLETED
PHASE3
165 participants
Baseline and up to 6 months
2013-12-09
Participant Flow
807 subjects screened; 165 subjects randomized to either Levonorgestrel Intrauterine System (LNG IUS) or Medroxyprogesterone acetate (MPA) for treatment of idiopathic menorrhagia; 145 subjects completed study.
Participant milestones
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
|
Overall Study
COMPLETED
|
73
|
72
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
Baseline characteristics by cohort
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=82 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=83 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
38.3 years
n=5 Participants
|
39.3 years
n=7 Participants
|
38.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body mass index
|
27.19 kg/m²
STANDARD_DEVIATION 3.903 • n=5 Participants
|
27.36 kg/m²
STANDARD_DEVIATION 4.610 • n=7 Participants
|
27.28 kg/m²
STANDARD_DEVIATION 4.263 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.
The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=79 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=81 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
|
-128.78 milliliter (mL)
Interval -393.6 to 1242.2
|
-17.7 milliliter (mL)
Interval -271.5 to 78.6
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.
End-of-study MBL \< 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=79 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=81 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percentage of Patients With Successful Treatment
|
84.8 Percentage of participants
|
22.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.
The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=79 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=81 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
|
-70.75 Percent change
Standard Deviation 88.31
|
-21.54 Percent change
Standard Deviation 35.79
|
SECONDARY outcome
Timeframe: Baseline and up to 3 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.
The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=79 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=81 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
|
-115.13 milliliter (mL)
Interval -405.8 to 54.4
|
-3.15 milliliter (mL)
Interval -270.9 to 146.7
|
SECONDARY outcome
Timeframe: Baseline and up to 3 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.
The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=79 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=81 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
|
-61.71 Percent change
Standard Deviation 41.76
|
-11.11 Percent change
Standard Deviation 42.46
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=79 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
0 days
|
97.53 percentage of participants
|
—
|
|
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
30 days
|
95.06 percentage of participants
|
—
|
|
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
60 days
|
93.83 percentage of participants
|
—
|
|
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
90 days
|
92.59 percentage of participants
|
—
|
|
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
120 days
|
91.36 percentage of participants
|
—
|
|
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
150 days
|
90.12 percentage of participants
|
—
|
|
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
180 days
|
90.12 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.
In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=81 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=82 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Total Number of Bleeding Days
Baseline
|
5.64 days
Standard Deviation 1.573
|
5.64 days
Standard Deviation 1.280
|
|
Total Number of Bleeding Days
Cycle 1
|
10.23 days
Standard Deviation 5.784
|
5.17 days
Standard Deviation 1.349
|
|
Total Number of Bleeding Days
Cycle 2
|
7.88 days
Standard Deviation 5.256
|
5.15 days
Standard Deviation 1.459
|
|
Total Number of Bleeding Days
Cycle 3
|
5.92 days
Standard Deviation 4.505
|
5.25 days
Standard Deviation 1.648
|
|
Total Number of Bleeding Days
Cycle 4
|
4.77 days
Standard Deviation 4.455
|
4.82 days
Standard Deviation 1.591
|
|
Total Number of Bleeding Days
Cycle 5
|
3.77 days
Standard Deviation 4.560
|
4.89 days
Standard Deviation 1.325
|
|
Total Number of Bleeding Days
Cycle 6
|
4.16 days
Standard Deviation 4.631
|
5.29 days
Standard Deviation 1.835
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.
In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=81 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=82 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Total Number of Spotting and Bleeding Days
Baseline
|
6.30 days
Standard Deviation 1.744
|
6.80 days
Standard Deviation 1.990
|
|
Total Number of Spotting and Bleeding Days
Cycle 1
|
19.70 days
Standard Deviation 7.894
|
6.65 days
Standard Deviation 2.265
|
|
Total Number of Spotting and Bleeding Days
Cycle 2
|
17.46 days
Standard Deviation 7.293
|
7.46 days
Standard Deviation 2.294
|
|
Total Number of Spotting and Bleeding Days
Cycle 3
|
11.89 days
Standard Deviation 7.415
|
6.92 days
Standard Deviation 2.569
|
|
Total Number of Spotting and Bleeding Days
Cycle 4
|
10.42 days
Standard Deviation 6.426
|
6.66 days
Standard Deviation 2.372
|
|
Total Number of Spotting and Bleeding Days
Cycle 5
|
10.25 days
Standard Deviation 7.359
|
6.89 days
Standard Deviation 2.482
|
|
Total Number of Spotting and Bleeding Days
Cycle 6
|
8.58 days
Standard Deviation 7.024
|
6.90 days
Standard Deviation 2.834
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.
In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=81 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=82 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Total Number of Spotting Days
Baseline
|
1.23 days
Standard Deviation 1.191
|
1.84 days
Standard Deviation 1.638
|
|
Total Number of Spotting Days
Cycle 1
|
9.47 days
Standard Deviation 6.933
|
1.48 days
Standard Deviation 1.613
|
|
Total Number of Spotting Days
Cycle 2
|
9.58 days
Standard Deviation 7.073
|
2.31 days
Standard Deviation 2.004
|
|
Total Number of Spotting Days
Cycle 3
|
7.27 days
Standard Deviation 6.421
|
2.27 days
Standard Deviation 2.150
|
|
Total Number of Spotting Days
Cycle 4
|
5.65 days
Standard Deviation 5.079
|
1.84 days
Standard Deviation 1.767
|
|
Total Number of Spotting Days
Cycle 5
|
6.48 days
Standard Deviation 5.869
|
2.00 days
Standard Deviation 2.297
|
|
Total Number of Spotting Days
Cycle 6
|
5.38 days
Standard Deviation 6.330
|
2.23 days
Standard Deviation 2.532
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.
A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=81 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=82 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Total Number of Bleeding Episodes
Baseline
|
1.01 number of bleeding episodes
Standard Deviation 0.075
|
1.03 number of bleeding episodes
Standard Deviation 0.115
|
|
Total Number of Bleeding Episodes
Cycle 1
|
1.75 number of bleeding episodes
Standard Deviation 0.707
|
0.98 number of bleeding episodes
Standard Deviation 0.222
|
|
Total Number of Bleeding Episodes
Cycle 2
|
0.88 number of bleeding episodes
Standard Deviation 0.653
|
1.01 number of bleeding episodes
Standard Deviation 0.194
|
|
Total Number of Bleeding Episodes
Cycle 3
|
0.99 number of bleeding episodes
Standard Deviation 0.647
|
0.97 number of bleeding episodes
Standard Deviation 0.228
|
|
Total Number of Bleeding Episodes
Cycle 4
|
0.76 number of bleeding episodes
Standard Deviation 0.615
|
0.99 number of bleeding episodes
Standard Deviation 0.202
|
|
Total Number of Bleeding Episodes
Cycle 5
|
0.77 number of bleeding episodes
Standard Deviation 0.755
|
1.01 number of bleeding episodes
Standard Deviation 0.208
|
|
Total Number of Bleeding Episodes
Cycle 6
|
0.70 number of bleeding episodes
Standard Deviation 0.739
|
1.04 number of bleeding episodes
Standard Deviation 0.359
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=75 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=75 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percent Change in Hemoglobin
Baseline to cycle 3
|
3.82 percent change
Interval -7.1 to 25.3
|
1.65 percent change
Interval -15.4 to 20.2
|
|
Percent Change in Hemoglobin
Cycle 3 to cycle 6
|
3.28 percent change
Interval -7.9 to 18.0
|
0.83 percent change
Interval -11.0 to 16.9
|
|
Percent Change in Hemoglobin
Baseline to cycle 6
|
7.50 percent change
Interval -3.6 to 44.0
|
1.87 percent change
Interval -17.9 to 33.3
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=75 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=75 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percent Change in Hematocrit
Baseline to cycle 3
|
4.9 percent change
Interval -8.0 to 21.0
|
0.0 percent change
Interval -15.0 to 21.0
|
|
Percent Change in Hematocrit
Cycle 3 to cycle 6
|
2.4 percent change
Interval -11.0 to 13.0
|
0.0 percent change
Interval -14.0 to 18.0
|
|
Percent Change in Hematocrit
Baseline to cycle 6
|
5.4 percent change
Interval -7.0 to 26.0
|
0.0 percent change
Interval -21.0 to 26.0
|
SECONDARY outcome
Timeframe: Baseline and up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 148 subjects (75 for LNG IUS and 73 for MPA) were available for the analysis.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=75 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=73 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percent Change in Serum Ferritin
Baseline to cycle 3
|
13.8 percent change
Interval -67.0 to 300.0
|
0.0 percent change
Interval -78.0 to 380.0
|
|
Percent Change in Serum Ferritin
Cycle 3 to cycle 6
|
48.3 percent change
Interval -51.0 to 293.0
|
16.7 percent change
Interval -78.0 to 560.0
|
|
Percent Change in Serum Ferritin
Baseline to cycle 6
|
68.8 percent change
Interval -52.0 to 1440.0
|
14.3 percent change
Interval -87.0 to 540.0
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.
"Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=78 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=82 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percentage of Patients With Improvement in the Investigator Global Assessment Scale
Cycle 3
|
94.7 percentage
|
71.2 percentage
|
|
Percentage of Patients With Improvement in the Investigator Global Assessment Scale
Cycle 6
|
93.6 percentage
|
61.0 percentage
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.
"Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'.
Outcome measures
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=78 Participants
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=82 Participants
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Percentage of Patients With Improvement in the Patients Overall Assessment Scale
Cycle 3
|
93.3 percentage
|
74.0 percentage
|
|
Percentage of Patients With Improvement in the Patients Overall Assessment Scale
Cycle 6
|
93.6 percentage
|
67.1 percentage
|
Adverse Events
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
Medroxyprogesterone Acetate (MPA)
Serious adverse events
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=82 participants at risk
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=83 participants at risk
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Reproductive system and breast disorders
Endometriosis
|
1.2%
1/82
|
0.00%
0/83
|
Other adverse events
| Measure |
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
n=82 participants at risk
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
|
Medroxyprogesterone Acetate (MPA)
n=83 participants at risk
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
3/82
|
2.4%
2/83
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.7%
3/82
|
6.0%
5/83
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
2/82
|
0.00%
0/83
|
|
General disorders
Fatique
|
4.9%
4/82
|
2.4%
2/83
|
|
General disorders
Irritability
|
2.4%
2/82
|
0.00%
0/83
|
|
Infections and infestations
Vaginitis bacterial
|
11.0%
9/82
|
3.6%
3/83
|
|
Infections and infestations
Urinary tract infection
|
7.3%
6/82
|
3.6%
3/83
|
|
Infections and infestations
Sinusitis
|
6.1%
5/82
|
4.8%
4/83
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
5/82
|
1.2%
1/83
|
|
Infections and infestations
Bronchitis
|
2.4%
2/82
|
1.2%
1/83
|
|
Infections and infestations
Gastroenteritis
|
2.4%
2/82
|
1.2%
1/83
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
2/82
|
3.6%
3/83
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.4%
2/82
|
0.00%
0/83
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.4%
2/82
|
3.6%
3/83
|
|
Injury, poisoning and procedural complications
IUCD complication
|
2.4%
2/82
|
0.00%
0/83
|
|
Injury, poisoning and procedural complications
Intra-uterine contraceptive device expelled
|
2.4%
2/82
|
0.00%
0/83
|
|
Investigations
Weight increased
|
6.1%
5/82
|
7.2%
6/83
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
3/82
|
4.8%
4/83
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/82
|
1.2%
1/83
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
2.4%
2/82
|
4.8%
4/83
|
|
Nervous system disorders
Headache
|
15.9%
13/82
|
10.8%
9/83
|
|
Psychiatric disorders
Depression
|
2.4%
2/82
|
1.2%
1/83
|
|
Psychiatric disorders
Libido decreased
|
2.4%
2/82
|
3.6%
3/83
|
|
Reproductive system and breast disorders
Ovarian cyst
|
12.2%
10/82
|
2.4%
2/83
|
|
Reproductive system and breast disorders
Breast tenderness
|
4.9%
4/82
|
3.6%
3/83
|
|
Reproductive system and breast disorders
Pelvis pain
|
4.9%
4/82
|
2.4%
2/83
|
|
Reproductive system and breast disorders
Breast cyst
|
3.7%
3/82
|
1.2%
1/83
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.7%
3/82
|
1.2%
1/83
|
|
Reproductive system and breast disorders
Uterine spasm
|
3.7%
3/82
|
1.2%
1/83
|
|
Reproductive system and breast disorders
Breast pain
|
2.4%
2/82
|
0.00%
0/83
|
|
Reproductive system and breast disorders
Coital bleeding
|
2.4%
2/82
|
0.00%
0/83
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.4%
2/82
|
3.6%
3/83
|
|
Reproductive system and breast disorders
Genital discharge
|
2.4%
2/82
|
0.00%
0/83
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.4%
2/82
|
0.00%
0/83
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.4%
2/82
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
2/82
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.1%
5/82
|
6.0%
5/83
|
|
Vascular disorders
Hypertension
|
6.1%
5/82
|
1.2%
1/83
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Principal Investigator shall provide Sponsor an advanced copy of any proposed publication at least 60 days prior to the planned date of publication. Sponsor shall have 30 days to recommend changes. Institution and Principal Investigator agree that adoption of recommended changes shall not be unreasonably refused.
- Publication restrictions are in place
Restriction type: OTHER