Trial · NCT01295294
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
NCT01295294, Phase 4, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA). Trials, record NCT01295294. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01295294
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
- NCT number
- NCT01295294
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 187 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Uterine Hemorrhage
- Interventions
- Tranexamic acid, Mefenamic acid, Placebo, Mirena (Levonorgestrel IUS, BAY86-5028)
- First posted
- 2011-02-14
- Last updated
- 2014-11-04
- Other registries' IDs
- eudract:2010-020922-16
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary efficacy variable will be the cumulative number of bleeding / spotting days | During 90 day double-blind treatment period | |
| Secondary | To describe and compare the bleeding patterns observed in women during treatment period | 90 day treatment period | |
| Secondary | To describe and compare the bleeding patterns observed in women during follow-up period | During the 30 day follow-up period | |
| Secondary | Satisfaction with oral blinded study drug treatment for bleeding / spotting | 90 day treatment period | |
| Secondary | Occurrence of dysmenorrhea | During 120 day study period | |
| Secondary | Continuation rate with study drug | During the 90 day treatment period | |
| Secondary | Continuation rate with Mirena | During 120 day study period | |
| Secondary | Adverse Events Collection | Until day 120 | |
| Secondary | Number of spotting-only days | During the 90-day treatment period | |
| Secondary | Number of bleeding / spotting episodes | During the 90-day treatment period |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23635728 | DERIVED |
Source PubMed
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01295294
GET https://conductscience.org/api/trials/v1/NCT01295294/registered