Menorrhagia
Conditions
Keywords
Idiopathic Menorrhagia
Brief summary
The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
Detailed description
Acronyms in the Adverse Event Section: * IUCD Intrauterine Contraceptive Device * MedDRA Medical Dictionary for Regulatory Activities This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.
Interventions
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
DRUGMedroxyprogesterone acetate
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who have \>/= 80 mL blood loss during their menstrual cycles and desire contraception
Exclusion criteria
* Post menopausal menstrual cycle \< 21 days or \> 35 days * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) | Baseline and up to 6 months | 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. |
| Percentage of Patients With Successful Treatment | At 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) | Baseline and up to 3 months | The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100. |
| Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | Baseline and up to 6 months | — |
| Total Number of Bleeding Days | Baseline and up to 6 months | 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. |
| Total Number of Spotting and Bleeding Days | Baseline and up to 6 months | 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. |
| Total Number of Spotting Days | Baseline and up to 6 months | 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. |
| Percent Change From Baseline MBL to End of Study MBL (Cycle 6) | Baseline and up to 6 months | The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100. |
| Percent Change in Hemoglobin | Baseline and up to 6 months | — |
| Percent Change in Hematocrit | Baseline and up to 6 months | — |
| Percent Change in Serum Ferritin | Baseline and up to 6 months | — |
| Percentage of Patients With Improvement in the Investigator Global Assessment Scale | Up to 6 months | 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' |
| Percentage of Patients With Improvement in the Patients Overall Assessment Scale | Up to 6 months | 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'. |
| Total Number of Bleeding Episodes | Baseline and up to 6 months | 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. |
| Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) | Baseline and up to 3 months | 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. |
Countries
Argentina, Brazil, Canada, Mexico, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. | 82 |
| Medroxyprogesterone Acetate (MPA) Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles. | 83 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Medroxyprogesterone Acetate (MPA) | Total |
|---|---|---|---|
| Age Continuous | 38.3 years | 39.3 years | 38.8 years |
| Body mass index | 27.19 kg/m² STANDARD_DEVIATION 3.903 | 27.36 kg/m² STANDARD_DEVIATION 4.61 | 27.28 kg/m² STANDARD_DEVIATION 4.263 |
| Sex: Female, Male Female | 82 Participants | 83 Participants | 165 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 67 / 82 | 52 / 83 |
| serious Total, serious adverse events | 1 / 82 | 0 / 83 |
Outcome results
Primary
Percentage of Patients With Successful Treatment
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Patients With Successful Treatment | 84.8 Percentage of participants |
| Medroxyprogesterone Acetate (MPA) | Percentage of Patients With Successful Treatment | 22.2 Percentage of participants |
Comparison: The null hypothesis: the proportion of subjects with successful treatment is equal in the LNG IUS group and the MPA group.p-value: <0.00195% CI: [50.56, 74.61]Chi-squared
Primary
The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) | -128.78 milliliter (mL) |
| Medroxyprogesterone Acetate (MPA) | The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) | -17.7 milliliter (mL) |
Comparison: 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.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) | -115.13 milliliter (mL) |
| Medroxyprogesterone Acetate (MPA) | Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) | -3.15 milliliter (mL) |
Comparison: The null hypothesis: the absolute change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Patients With Improvement in the Investigator Global Assessment Scale
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Patients With Improvement in the Investigator Global Assessment Scale | Cycle 3 | 94.7 percentage |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Patients With Improvement in the Investigator Global Assessment Scale | Cycle 6 | 93.6 percentage |
| Medroxyprogesterone Acetate (MPA) | Percentage of Patients With Improvement in the Investigator Global Assessment Scale | Cycle 3 | 71.2 percentage |
| Medroxyprogesterone Acetate (MPA) | Percentage of Patients With Improvement in the Investigator Global Assessment Scale | Cycle 6 | 61.0 percentage |
Secondary
Percentage of Patients With Improvement in the Patients Overall Assessment Scale
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Patients With Improvement in the Patients Overall Assessment Scale | Cycle 3 | 93.3 percentage |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Patients With Improvement in the Patients Overall Assessment Scale | Cycle 6 | 93.6 percentage |
| Medroxyprogesterone Acetate (MPA) | Percentage of Patients With Improvement in the Patients Overall Assessment Scale | Cycle 3 | 74.0 percentage |
| Medroxyprogesterone Acetate (MPA) | Percentage of Patients With Improvement in the Patients Overall Assessment Scale | Cycle 6 | 67.1 percentage |
Comparison: A two-sided 95% confidence interval for the improvement rate will be provided for cycle 695% CI: [14.75, 37.36]
Secondary
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
Time frame: Baseline and up to 6 months
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | 0 days | 97.53 percentage of participants |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | 30 days | 95.06 percentage of participants |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | 60 days | 93.83 percentage of participants |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | 90 days | 92.59 percentage of participants |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | 120 days | 91.36 percentage of participants |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | 150 days | 90.12 percentage of participants |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | 180 days | 90.12 percentage of participants |
Secondary
Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.
Time frame: Baseline and up to 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change From Baseline MBL to End of Study MBL (Cycle 6) | -70.75 Percent change | Standard Deviation 88.31 |
| Medroxyprogesterone Acetate (MPA) | Percent Change From Baseline MBL to End of Study MBL (Cycle 6) | -21.54 Percent change | Standard Deviation 35.79 |
Comparison: 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.p-value: <0.00195% CI: [-70.2, -28.3]t-test, 2 sided
Secondary
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.
Time frame: Baseline and up to 3 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) | -61.71 Percent change | Standard Deviation 41.76 |
| Medroxyprogesterone Acetate (MPA) | Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) | -11.11 Percent change | Standard Deviation 42.46 |
Comparison: The null hypothesis: the percent change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.p-value: <0.00195% CI: [-63.8, -37.4]t-test, 2 sided
Secondary
Percent Change in Hematocrit
Time frame: Baseline and up to 6 months
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Hematocrit | Baseline to cycle 3 | 4.9 percent change |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Hematocrit | Cycle 3 to cycle 6 | 2.4 percent change |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Hematocrit | Baseline to cycle 6 | 5.4 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Hematocrit | Baseline to cycle 3 | 0.0 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Hematocrit | Cycle 3 to cycle 6 | 0.0 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Hematocrit | Baseline to cycle 6 | 0.0 percent change |
Secondary
Percent Change in Hemoglobin
Time frame: Baseline and up to 6 months
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Hemoglobin | Cycle 3 to cycle 6 | 3.28 percent change |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Hemoglobin | Baseline to cycle 6 | 7.50 percent change |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Hemoglobin | Baseline to cycle 3 | 3.82 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Hemoglobin | Baseline to cycle 3 | 1.65 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Hemoglobin | Cycle 3 to cycle 6 | 0.83 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Hemoglobin | Baseline to cycle 6 | 1.87 percent change |
Secondary
Percent Change in Serum Ferritin
Time frame: Baseline and up to 6 months
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Serum Ferritin | Baseline to cycle 3 | 13.8 percent change |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Serum Ferritin | Cycle 3 to cycle 6 | 48.3 percent change |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Percent Change in Serum Ferritin | Baseline to cycle 6 | 68.8 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Serum Ferritin | Baseline to cycle 3 | 0.0 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Serum Ferritin | Cycle 3 to cycle 6 | 16.7 percent change |
| Medroxyprogesterone Acetate (MPA) | Percent Change in Serum Ferritin | Baseline to cycle 6 | 14.3 percent change |
Secondary
Total Number of Bleeding Days
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Days | Cycle 2 | 7.88 days | Standard Deviation 5.256 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Days | Cycle 4 | 4.77 days | Standard Deviation 4.455 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Days | Cycle 1 | 10.23 days | Standard Deviation 5.784 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Days | Cycle 5 | 3.77 days | Standard Deviation 4.56 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Days | Cycle 3 | 5.92 days | Standard Deviation 4.505 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Days | Cycle 6 | 4.16 days | Standard Deviation 4.631 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Days | Baseline | 5.64 days | Standard Deviation 1.573 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Days | Cycle 6 | 5.29 days | Standard Deviation 1.835 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Days | Baseline | 5.64 days | Standard Deviation 1.28 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Days | Cycle 1 | 5.17 days | Standard Deviation 1.349 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Days | Cycle 2 | 5.15 days | Standard Deviation 1.459 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Days | Cycle 3 | 5.25 days | Standard Deviation 1.648 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Days | Cycle 4 | 4.82 days | Standard Deviation 1.591 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Days | Cycle 5 | 4.89 days | Standard Deviation 1.325 |
Secondary
Total Number of Bleeding Episodes
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Episodes | Cycle 2 | 0.88 number of bleeding episodes | Standard Deviation 0.653 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Episodes | Cycle 4 | 0.76 number of bleeding episodes | Standard Deviation 0.615 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Episodes | Cycle 1 | 1.75 number of bleeding episodes | Standard Deviation 0.707 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Episodes | Cycle 5 | 0.77 number of bleeding episodes | Standard Deviation 0.755 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Episodes | Cycle 3 | 0.99 number of bleeding episodes | Standard Deviation 0.647 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Episodes | Cycle 6 | 0.70 number of bleeding episodes | Standard Deviation 0.739 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Bleeding Episodes | Baseline | 1.01 number of bleeding episodes | Standard Deviation 0.075 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Episodes | Cycle 6 | 1.04 number of bleeding episodes | Standard Deviation 0.359 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Episodes | Baseline | 1.03 number of bleeding episodes | Standard Deviation 0.115 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Episodes | Cycle 1 | 0.98 number of bleeding episodes | Standard Deviation 0.222 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Episodes | Cycle 2 | 1.01 number of bleeding episodes | Standard Deviation 0.194 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Episodes | Cycle 3 | 0.97 number of bleeding episodes | Standard Deviation 0.228 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Episodes | Cycle 4 | 0.99 number of bleeding episodes | Standard Deviation 0.202 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Bleeding Episodes | Cycle 5 | 1.01 number of bleeding episodes | Standard Deviation 0.208 |
Secondary
Total Number of Spotting and Bleeding Days
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting and Bleeding Days | Cycle 2 | 17.46 days | Standard Deviation 7.293 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting and Bleeding Days | Cycle 4 | 10.42 days | Standard Deviation 6.426 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting and Bleeding Days | Cycle 1 | 19.70 days | Standard Deviation 7.894 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting and Bleeding Days | Cycle 5 | 10.25 days | Standard Deviation 7.359 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting and Bleeding Days | Cycle 3 | 11.89 days | Standard Deviation 7.415 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting and Bleeding Days | Cycle 6 | 8.58 days | Standard Deviation 7.024 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting and Bleeding Days | Baseline | 6.30 days | Standard Deviation 1.744 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting and Bleeding Days | Cycle 6 | 6.90 days | Standard Deviation 2.834 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting and Bleeding Days | Baseline | 6.80 days | Standard Deviation 1.99 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting and Bleeding Days | Cycle 1 | 6.65 days | Standard Deviation 2.265 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting and Bleeding Days | Cycle 2 | 7.46 days | Standard Deviation 2.294 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting and Bleeding Days | Cycle 3 | 6.92 days | Standard Deviation 2.569 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting and Bleeding Days | Cycle 4 | 6.66 days | Standard Deviation 2.372 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting and Bleeding Days | Cycle 5 | 6.89 days | Standard Deviation 2.482 |
Secondary
Total Number of Spotting Days
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting Days | Cycle 2 | 9.58 days | Standard Deviation 7.073 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting Days | Cycle 4 | 5.65 days | Standard Deviation 5.079 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting Days | Cycle 1 | 9.47 days | Standard Deviation 6.933 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting Days | Cycle 5 | 6.48 days | Standard Deviation 5.869 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting Days | Cycle 3 | 7.27 days | Standard Deviation 6.421 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting Days | Cycle 6 | 5.38 days | Standard Deviation 6.33 |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | Total Number of Spotting Days | Baseline | 1.23 days | Standard Deviation 1.191 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting Days | Cycle 6 | 2.23 days | Standard Deviation 2.532 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting Days | Baseline | 1.84 days | Standard Deviation 1.638 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting Days | Cycle 1 | 1.48 days | Standard Deviation 1.613 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting Days | Cycle 2 | 2.31 days | Standard Deviation 2.004 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting Days | Cycle 3 | 2.27 days | Standard Deviation 2.15 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting Days | Cycle 4 | 1.84 days | Standard Deviation 1.767 |
| Medroxyprogesterone Acetate (MPA) | Total Number of Spotting Days | Cycle 5 | 2.00 days | Standard Deviation 2.297 |