Trial · NCT02985541
Mirena Extension Trial
NCT02985541, Phase 3, Completed, Bayer; results first posted 2022-04-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mirena Extension Trial. Trials, record NCT02985541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02985541
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirena Extension Trial
- NCT number
- NCT02985541
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 364 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Contraception
- Interventions
- Levonorgestrel IUS (Mirena, BAY86-5028)
- First posted
- 2016-12-07
- Last updated
- 2022-04-28
- Results first posted
- 2022-04-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use | Years 6 to 8 of Mirena use | The Pearl Index (PI) is defined as the number of pregnancies per 100 women years. The 3-year PI (Years 6 to 8) was obtained by dividing the number of pregnancies the occurred during that time (starting at Day 1 Year 6 and up to Day 365 of Year 8) by the time (in 100 women years) that the women were at risk of getting pregnant during that time. |
| Secondary | Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 | Baseline and end of Years 6, 7 and 8 of Mirena use | Menstrual blood loss (MBL) during a 30-day period starting at the baseline visit and at the end of Year 6, Year 7, and Year 8, measured by the alkaline hematin method. The assessment of this variable was restricted to women who had Mirena inserted for heavy menstrual bleeding (HMB). |
| Secondary | Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use | At end of Year 6, 7 and 8 of Mirena use | Categorized menstrual blood loss (MBL) (≥ 80 mL per 30 days) at end of Year 6, Year 7, and Year 8. The assessment of this variable was restricted to women who had Mirena inserted for HMB. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Years 6 to 8 of Mirena use | Adverse event (AE) was defined as any untoward medical occurrence (ie any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. Serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose 1) resulted in death, 2) was life-threatening, 3) required inpatient hospitalization or prolongation of existing hospitalization, 4) resulted in persistent or significant disability/incapacity, 5) was a congenital anomaly/birth defect, or 6) was another medically important serious event as judged by the investigator. Treatment-emergent adverse event (TEAE) was defined as an AE that occurred on Day 1 Year 6 of Mirena use or later. |
| Other | Total LNG Concentrations in Plasma Estimated Based on the Final 8-year Population Pharmacokinetics (popPK) Model | At the beginning of Year 6 (baseline) and at the end of Years 6, 7, and 8 of Mirena use | A population pharmacokinetic (popPK) analysis was performed including sparse data from the study. |
| Other | Participant's Satisfaction With Mirena by Visit | Baseline, at end of Year 6, 7 and 8 of Mirena use | Participants were asked to evaluate their satisfaction with Mirena on a 5-point scale as very satisfied, somewhat satisfied, neither satisfied or dissatisfied, dissatisfied or very dissatisfied. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use | Years 6 to 8 of Mirena use | All women in the full analysis set (FAS) with an age of 33 years or younger at baseline visit (i.e. an age of 36 or younger at end of year 8). | Pregnancies per 100 women years | NUMBER |
| SECONDARY | Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 | Baseline and end of Years 6, 7 and 8 of Mirena use | Women who had Mirena inserted for HMB | mL/30 days | MEDIAN |
| SECONDARY | Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use | At end of Year 6, 7 and 8 of Mirena use | Women who had Mirena inserted for HMB | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Years 6 to 8 of Mirena use | Safety analysis set (SAF): All women who completed the baseline visit of the study, analyzed for the FAS. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Total LNG Concentrations in Plasma Estimated Based on the Final 8-year Population Pharmacokinetics (popPK) Model | At the beginning of Year 6 (baseline) and at the end of Years 6, 7, and 8 of Mirena use | Concentrations were estimated for women who had Mirena still in place. | ng/L | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Participant's Satisfaction With Mirena by Visit | Baseline, at end of Year 6, 7 and 8 of Mirena use | Full analysis set (FAS): All women who completed the baseline visit of the study. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use | Levonorgestrel IUS (Mirena, BAY86-5028) | 0.28 | 95% Confidence Interval 0.03 to 1.00 | Pregnancies per 100 women years | |
| Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 | Levonorgestrel IUS (Mirena, BAY86-5028) | Beginning of Year 6 (baseline) | 0.000 | Full Range 0.00 to 2.32 | mL/30 days |
| Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 | Levonorgestrel IUS (Mirena, BAY86-5028) | End of Year 6 | 0.000 | Full Range 0.00 to 0.00 | mL/30 days |
| Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 | Levonorgestrel IUS (Mirena, BAY86-5028) | End of Year 7 | 0.000 | Full Range 0.00 to 0.00 | mL/30 days |
| Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 | Levonorgestrel IUS (Mirena, BAY86-5028) | End of Year 8 | 0.000 | Full Range 0.00 to 0.00 | mL/30 days |
| Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use | Levonorgestrel IUS (Mirena, BAY86-5028) | End of Year 6 | 0 | Participants | |
| Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use | Levonorgestrel IUS (Mirena, BAY86-5028) | End of Year 7 | 0 | Participants | |
| Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use | Levonorgestrel IUS (Mirena, BAY86-5028) | End of Year 8 | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Levonorgestrel IUS (Mirena, BAY86-5028) | Any AE | 249 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Levonorgestrel IUS (Mirena, BAY86-5028) | Any SAE | 14 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 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 IUS (Mirena, BAY86-5028) | 364 | |
| Overall Study | Valid for FAS | Levonorgestrel IUS (Mirena, BAY86-5028) | 362 | |
| Overall Study | Continued Into Year 7 of Mirena Use | Levonorgestrel IUS (Mirena, BAY86-5028) | 305 | |
| Overall Study | Continued Into Year 8 of Mirena Use | Levonorgestrel IUS (Mirena, BAY86-5028) | 243 | |
| Overall Study | COMPLETED | Levonorgestrel IUS (Mirena, BAY86-5028) | 223 | |
| Overall Study | NOT COMPLETED | Levonorgestrel IUS (Mirena, BAY86-5028) | 141 |
Source ClinicalTrials.gov
Adverse events20
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 | Bacterial vaginosis | Infections and infestations | Levonorgestrel IUS (Mirena, BAY86-5028) | 27 | 362 | 40 |
| other | Nasopharyngitis | Infections and infestations | Levonorgestrel IUS (Mirena, BAY86-5028) | 21 | 362 | 29 |
| other | Urinary tract infection | Infections and infestations | Levonorgestrel IUS (Mirena, BAY86-5028) | 27 | 362 | 35 |
| other | Weight increased | Investigations | Levonorgestrel IUS (Mirena, BAY86-5028) | 33 | 362 | 33 |
| other | Anxiety | Psychiatric disorders | Levonorgestrel IUS (Mirena, BAY86-5028) | 20 | 362 | 22 |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Levonorgestrel IUS (Mirena, BAY86-5028) | 1 | 362 | 1 |
| serious | Volvulus | Gastrointestinal disorders | Levonorgestrel IUS (Mirena, BAY86-5028) | 1 | 362 | 1 |
| serious | Tooth abscess | Infections and infestations | Levonorgestrel IUS (Mirena, BAY86-5028) | 1 | 362 | 1 |
| serious | Urinary tract infection | Infections and infestations | Levonorgestrel IUS (Mirena, BAY86-5028) | 1 | 362 | 1 |
| serious | Uterine perforation | Injury, poisoning and procedural complications | Levonorgestrel IUS (Mirena, BAY86-5028) | 3 | 362 | 3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levonorgestrel IUS (Mirena, BAY86-5028) | 0 | 362 |
| Total, other adverse events | Levonorgestrel IUS (Mirena, BAY86-5028) | 107 | 362 |
| Total, serious adverse events | Levonorgestrel IUS (Mirena, BAY86-5028) | 14 | 362 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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