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Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

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ClinicalTrials.gov Identifier: NCT00360490
Recruitment Status : Completed
First Posted : August 4, 2006
Results First Posted : November 19, 2009
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Menorrhagia
Interventions Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Drug: Medroxyprogesterone acetate
Enrollment 165
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Period Title: Overall Study
Started 82 83
Completed 73 72
Not Completed 9 11
Reason Not Completed
Adverse Event             4             2
Lost to Follow-up             2             1
Physician Decision             2             1
Protocol Violation             0             4
Withdrawal by Subject             1             3
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA) Total
Hide Arm/Group Description Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles. Total of all reporting groups
Overall Number of Baseline Participants 82 83 165
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 82 participants 83 participants 165 participants
38.3
(26 to 50)
39.3
(26 to 53)
38.8
(26 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 83 participants 165 participants
Female
82
 100.0%
83
 100.0%
165
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Body mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 82 participants 83 participants 165 participants
27.19  (3.903) 27.36  (4.610) 27.28  (4.263)
[1]
Measure Description: There is one participant [patient identifier (pid) =11407] missing in Levonorgestrel Intrauterine System group.
1.Primary Outcome
Title The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
Hide Description 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.
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 79 81
Median (Full Range)
Unit of Measure: milliliter (mL)
-128.78
(-393.6 to 1242.2)
-17.7
(-271.5 to 78.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours, Medroxyprogesterone Acetate (MPA)
Comments The null hypothesis: the absolute change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Patients With Successful Treatment
Hide Description 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.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 79 81
Measure Type: Number
Unit of Measure: Percentage of participants
84.8 22.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours, Medroxyprogesterone Acetate (MPA)
Comments The null hypothesis: the proportion of subjects with successful treatment is equal in the LNG IUS group and the MPA group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 62.59
Confidence Interval 95%
50.56 to 74.61
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
Hide Description The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 79 81
Mean (Standard Deviation)
Unit of Measure: Percent change
-70.75  (88.31) -21.54  (35.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours, Medroxyprogesterone Acetate (MPA)
Comments The null hypothesis: the percent change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -49.2
Confidence Interval 95%
-70.2 to -28.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
Hide Description 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.
Time Frame Baseline and up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 79 81
Median (Full Range)
Unit of Measure: milliliter (mL)
-115.13
(-405.8 to 54.4)
-3.15
(-270.9 to 146.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours, Medroxyprogesterone Acetate (MPA)
Comments The null hypothesis: the absolute change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
Hide Description The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.
Time Frame Baseline and up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 79 81
Mean (Standard Deviation)
Unit of Measure: Percent change
-61.71  (41.76) -11.11  (42.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours, Medroxyprogesterone Acetate (MPA)
Comments The null hypothesis: the percent change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -50.6
Confidence Interval 95%
-63.8 to -37.4
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
Hide Description [Not Specified]
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: percentage of participants
0 days 97.53
30 days 95.06
60 days 93.83
90 days 92.59
120 days 91.36
150 days 90.12
180 days 90.12
7.Secondary Outcome
Title Total Number of Bleeding Days
Hide Description 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.
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 81 82
Mean (Standard Deviation)
Unit of Measure: days
Baseline 5.64  (1.573) 5.64  (1.280)
Cycle 1 10.23  (5.784) 5.17  (1.349)
Cycle 2 7.88  (5.256) 5.15  (1.459)
Cycle 3 5.92  (4.505) 5.25  (1.648)
Cycle 4 4.77  (4.455) 4.82  (1.591)
Cycle 5 3.77  (4.560) 4.89  (1.325)
Cycle 6 4.16  (4.631) 5.29  (1.835)
8.Secondary Outcome
Title Total Number of Spotting and Bleeding Days
Hide Description 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.
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 81 82
Mean (Standard Deviation)
Unit of Measure: days
Baseline 6.30  (1.744) 6.80  (1.990)
Cycle 1 19.70  (7.894) 6.65  (2.265)
Cycle 2 17.46  (7.293) 7.46  (2.294)
Cycle 3 11.89  (7.415) 6.92  (2.569)
Cycle 4 10.42  (6.426) 6.66  (2.372)
Cycle 5 10.25  (7.359) 6.89  (2.482)
Cycle 6 8.58  (7.024) 6.90  (2.834)
9.Secondary Outcome
Title Total Number of Spotting Days
Hide Description 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.
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 81 82
Mean (Standard Deviation)
Unit of Measure: days
Baseline 1.23  (1.191) 1.84  (1.638)
Cycle 1 9.47  (6.933) 1.48  (1.613)
Cycle 2 9.58  (7.073) 2.31  (2.004)
Cycle 3 7.27  (6.421) 2.27  (2.150)
Cycle 4 5.65  (5.079) 1.84  (1.767)
Cycle 5 6.48  (5.869) 2.00  (2.297)
Cycle 6 5.38  (6.330) 2.23  (2.532)
10.Secondary Outcome
Title Total Number of Bleeding Episodes
Hide Description 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.
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 81 82
Mean (Standard Deviation)
Unit of Measure: number of bleeding episodes
Baseline 1.01  (0.075) 1.03  (0.115)
Cycle 1 1.75  (0.707) 0.98  (0.222)
Cycle 2 0.88  (0.653) 1.01  (0.194)
Cycle 3 0.99  (0.647) 0.97  (0.228)
Cycle 4 0.76  (0.615) 0.99  (0.202)
Cycle 5 0.77  (0.755) 1.01  (0.208)
Cycle 6 0.70  (0.739) 1.04  (0.359)
11.Secondary Outcome
Title Percent Change in Hemoglobin
Hide Description [Not Specified]
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 75 75
Median (Full Range)
Unit of Measure: percent change
Baseline to cycle 3
3.82
(-7.1 to 25.3)
1.65
(-15.4 to 20.2)
Cycle 3 to cycle 6
3.28
(-7.9 to 18.0)
0.83
(-11.0 to 16.9)
Baseline to cycle 6
7.50
(-3.6 to 44.0)
1.87
(-17.9 to 33.3)
12.Secondary Outcome
Title Percent Change in Hematocrit
Hide Description [Not Specified]
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 75 75
Median (Full Range)
Unit of Measure: percent change
Baseline to cycle 3
4.9
(-8 to 21)
0.0
(-15 to 21)
Cycle 3 to cycle 6
2.4
(-11 to 13)
0.0
(-14 to 18)
Baseline to cycle 6
5.4
(-7 to 26)
0.0
(-21 to 26)
13.Secondary Outcome
Title Percent Change in Serum Ferritin
Hide Description [Not Specified]
Time Frame Baseline and up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 75 73
Median (Full Range)
Unit of Measure: percent change
Baseline to cycle 3
13.8
(-67 to 300)
0.0
(-78 to 380)
Cycle 3 to cycle 6
48.3
(-51 to 293)
16.7
(-78 to 560)
Baseline to cycle 6
68.8
(-52 to 1440)
14.3
(-87 to 540)
14.Secondary Outcome
Title Percentage of Patients With Improvement in the Investigator Global Assessment Scale
Hide Description “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’
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 78 82
Measure Type: Number
Unit of Measure: percentage
Cycle 3 94.7 71.2
Cycle 6 93.6 61.0
15.Secondary Outcome
Title Percentage of Patients With Improvement in the Patients Overall Assessment Scale
Hide Description “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’.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description:
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Overall Number of Participants Analyzed 78 82
Measure Type: Number
Unit of Measure: percentage
Cycle 3 93.3 74.0
Cycle 6 93.6 67.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours, Medroxyprogesterone Acetate (MPA)
Comments A two-sided 95% confidence interval for the improvement rate will be provided for cycle 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 26.06
Confidence Interval 95%
14.75 to 37.36
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Hide Arm/Group Description Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
All-Cause Mortality
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/82 (1.22%)   0/83 (0.00%) 
Reproductive system and breast disorders     
Endometriosis * 1  1/82 (1.22%)  0/83 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Medroxyprogesterone Acetate (MPA)
Affected / at Risk (%) Affected / at Risk (%)
Total   67/82 (81.71%)   52/83 (62.65%) 
Gastrointestinal disorders     
Abdominal pain * 1  3/82 (3.66%)  2/83 (2.41%) 
Abdominal pain lower * 1  3/82 (3.66%)  5/83 (6.02%) 
Flatulence * 1  2/82 (2.44%)  0/83 (0.00%) 
General disorders     
Fatique * 1  4/82 (4.88%)  2/83 (2.41%) 
Irritability * 1  2/82 (2.44%)  0/83 (0.00%) 
Infections and infestations     
Vaginitis bacterial * 1  9/82 (10.98%)  3/83 (3.61%) 
Urinary tract infection * 1  6/82 (7.32%)  3/83 (3.61%) 
Sinusitis * 1  5/82 (6.10%)  4/83 (4.82%) 
Upper respiratory tract infection * 1  5/82 (6.10%)  1/83 (1.20%) 
Bronchitis * 1  2/82 (2.44%)  1/83 (1.20%) 
Gastroenteritis * 1  2/82 (2.44%)  1/83 (1.20%) 
Nasopharyngitis * 1  2/82 (2.44%)  3/83 (3.61%) 
Viral upper respiratory tract infection * 1  2/82 (2.44%)  0/83 (0.00%) 
Vulvovaginal mycotic infection * 1  2/82 (2.44%)  3/83 (3.61%) 
Injury, poisoning and procedural complications     
IUCD complication * 1  2/82 (2.44%)  0/83 (0.00%) 
Intra-uterine contraceptive device expelled * 1  2/82 (2.44%)  0/83 (0.00%) 
Investigations     
Weight increased * 1  5/82 (6.10%)  6/83 (7.23%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/82 (3.66%)  4/83 (4.82%) 
Back pain * 1  2/82 (2.44%)  1/83 (1.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma * 1  2/82 (2.44%)  4/83 (4.82%) 
Nervous system disorders     
Headache * 1  13/82 (15.85%)  9/83 (10.84%) 
Psychiatric disorders     
Depression * 1  2/82 (2.44%)  1/83 (1.20%) 
Libido decreased * 1  2/82 (2.44%)  3/83 (3.61%) 
Reproductive system and breast disorders     
Ovarian cyst * 1  10/82 (12.20%)  2/83 (2.41%) 
Breast tenderness * 1  4/82 (4.88%)  3/83 (3.61%) 
Pelvis pain * 1  4/82 (4.88%)  2/83 (2.41%) 
Breast cyst * 1  3/82 (3.66%)  1/83 (1.20%) 
Menorrhagia * 1  3/82 (3.66%)  1/83 (1.20%) 
Uterine spasm * 1  3/82 (3.66%)  1/83 (1.20%) 
Breast pain * 1  2/82 (2.44%)  0/83 (0.00%) 
Coital bleeding * 1  2/82 (2.44%)  0/83 (0.00%) 
Dysmenorrhoea * 1  2/82 (2.44%)  3/83 (3.61%) 
Genital discharge * 1  2/82 (2.44%)  0/83 (0.00%) 
Metrorrhagia * 1  2/82 (2.44%)  0/83 (0.00%) 
Vaginal discharge * 1  2/82 (2.44%)  1/83 (1.20%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/82 (2.44%)  0/83 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  5/82 (6.10%)  5/83 (6.02%) 
Vascular disorders     
Hypertension * 1  5/82 (6.10%)  1/83 (1.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00360490     History of Changes
Obsolete Identifiers: NCT00360620
Other Study ID Numbers: 91518
309849 ( Other Identifier: Bayer )
First Submitted: August 2, 2006
First Posted: August 4, 2006
Results First Submitted: October 13, 2009
Results First Posted: November 19, 2009
Last Update Posted: December 9, 2013