Trial · NCT00360490
Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
NCT00360490, Phase 3, Completed, Bayer; results first posted 2009-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS). Trials, record NCT00360490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00360490
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT00360490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 165 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Menorrhagia
- Interventions
- Levonorgestrel IUS (Mirena, BAY86-5028), Medroxyprogesterone acetate
- First posted
- 2006-08-04
- Last updated
- 2013-12-09
- Results first posted
- 2009-11-19
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | Baseline and up to 6 months | |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | milliliter (mL) | MEDIAN |
| PRIMARY | Percentage of Patients With Successful Treatment | At 6 months | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline MBL to End of Study MBL (Cycle 6) | Baseline and up to 6 months | 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. | Percent change | MEAN |
| SECONDARY | Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) | Baseline and up to 3 months | 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. | milliliter (mL) | MEDIAN |
| SECONDARY | Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) | Baseline and up to 3 months | 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. | Percent change | MEAN |
| SECONDARY | Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group | Baseline and up to 6 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Total Number of Bleeding Days | Baseline and up to 6 months | 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. | days | MEAN |
| SECONDARY | Total Number of Spotting and Bleeding Days | Baseline and up to 6 months | 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. | days | MEAN |
| SECONDARY | Total Number of Spotting Days | Baseline and up to 6 months | 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. | days | MEAN |
| SECONDARY | Total Number of Bleeding Episodes | Baseline and up to 6 months | 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. | number of bleeding episodes | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | -128.78 | Full Range -393.6 to 1242.2 | milliliter (mL) | |
| The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) | Medroxyprogesterone Acetate (MPA) | -17.7 | Full Range -271.5 to 78.6 | milliliter (mL) | |
| Percentage of Patients With Successful Treatment | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 84.8 | Percentage of participants | ||
| Percentage of Patients With Successful Treatment | Medroxyprogesterone Acetate (MPA) | 22.2 | Percentage of participants | ||
| Percent Change From Baseline MBL to End of Study MBL (Cycle 6) | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | -70.75 | Standard Deviation 88.31 | Percent change | |
| Percent Change From Baseline MBL to End of Study MBL (Cycle 6) | Medroxyprogesterone Acetate (MPA) | -21.54 | Standard Deviation 35.79 | Percent change | |
| Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | -115.13 | Full Range -405.8 to 54.4 | milliliter (mL) | |
| Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) | Medroxyprogesterone Acetate (MPA) | -3.15 | Full Range -270.9 to 146.7 | milliliter (mL) | |
| Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | -61.71 | Standard Deviation 41.76 | Percent change | |
| Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) | Medroxyprogesterone Acetate (MPA) | -11.11 | Standard Deviation 42.46 | Percent change |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 82 | |
| Overall Study | STARTED | Medroxyprogesterone Acetate (MPA) | 83 | |
| Overall Study | COMPLETED | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 73 | |
| Overall Study | COMPLETED | Medroxyprogesterone Acetate (MPA) | 72 | |
| Overall Study | NOT COMPLETED | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 9 | |
| Overall Study | NOT COMPLETED | Medroxyprogesterone Acetate (MPA) | 11 |
Source ClinicalTrials.gov
Adverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 3 | 82 | |
| other | Abdominal pain | Gastrointestinal disorders | Medroxyprogesterone Acetate (MPA) | 2 | 83 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 3 | 82 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Medroxyprogesterone Acetate (MPA) | 5 | 83 | |
| other | Flatulence | Gastrointestinal disorders | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 2 | 82 | |
| other | Flatulence | Gastrointestinal disorders | Medroxyprogesterone Acetate (MPA) | 0 | 83 | |
| other | Fatique | General disorders | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 4 | 82 | |
| other | Fatique | General disorders | Medroxyprogesterone Acetate (MPA) | 2 | 83 | |
| other | Irritability | General disorders | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 2 | 82 | |
| other | Irritability | General disorders | Medroxyprogesterone Acetate (MPA) | 0 | 83 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | ||
| Total, all-cause mortality | Medroxyprogesterone Acetate (MPA) | ||
| Total, other adverse events | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 67 | 82 |
| Total, other adverse events | Medroxyprogesterone Acetate (MPA) | 52 | 83 |
| Total, serious adverse events | Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours | 1 | 82 |
| Total, serious adverse events | Medroxyprogesterone Acetate (MPA) | 0 | 83 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours vs Medroxyprogesterone Acetate (MPA): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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