Trial · NCT02829957
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
NCT02829957, Phase 2, Phase 3, Completed, Indiana University; results first posted 2023-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding. Trials, record NCT02829957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02829957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
- NCT number
- NCT02829957
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 19 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Venous Thromboembolism, Menstruation
- Interventions
- Apixaban, Rivaroxaban
- First posted
- 2016-07-12
- Last updated
- 2023-11-13
- Results first posted
- 2023-05-10
- Limitations and caveats
- Terminated secondary to low rate of enrollment despite extraordinary recruitment efforts.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PBAC Scores | 3 months | Measure Description: A PBAC Score of \< 100 indicates a normal menstrual cycle. The lowest possible score would be zero. Higher values indicate worse outcomes. The higher theoretical range value cannot be calculated. The scoring mechanism is as follows; Towels * 1 point for each lightly stained towel * 5 points or each moderately soiled towel * 20 points if the towel is completely saturated with blood Tampons * 1 point for each lightly stained tampon * 5 points for each moderately soiled tampon * 10 points if the tampon is completely saturated with blood Clots * 1 point for small clots * 5 points for large clots |
| Secondary | Number of Participants Who Discontinued Planned Drug Administration | 3 months | |
| Secondary | Number of Patients That Held Drug for Menorrhagia | 1, 2, and 3 months | |
| Secondary | Number of Participants With Major Hemorrhage | 3 months | |
| Secondary | Number of Participants With Venous Thromboembolism (VTE) | 3 months | |
| Secondary | Number of Participants Who Crossed Over to Another Anticoagulant | 3 months | |
| Secondary | Number of Participants With Clinically Relevant Non-major Bleeding | 3 months | |
| Secondary | Hemoglobin Concentration | 3 months | Measure Description: Normal hemoglobin range for adult women - 12 - 16 g/dL. Lower levels indicate worse outcomes. |
| Secondary | Physical Component Summary of Standard From 36 | 3 months | The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PBAC Scores | 3 months | The number of participants at baseline differ from those of the outcome measurements because some participants were lost to followup. | score on a scale | MEDIAN |
| SECONDARY | Number of Participants Who Discontinued Planned Drug Administration | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients That Held Drug for Menorrhagia | 1, 2, and 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Major Hemorrhage | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Venous Thromboembolism (VTE) | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Crossed Over to Another Anticoagulant | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Clinically Relevant Non-major Bleeding | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hemoglobin Concentration | 3 months | The number of participants at baseline differ from those of the outcome measurements because some participants were lost to followup. | g/dl | MEDIAN |
| SECONDARY | Physical Component Summary of Standard From 36 | 3 months | The number of participants at baseline differ from those of the outcome measurements because some participants were lost to followup. | Score | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PBAC Scores | Rivaroxaban | 292 | Full Range 74 to 600 | score on a scale | |
| PBAC Scores | Apixaban | 146 | Full Range 3 to 378 | score on a scale | |
| Number of Participants Who Discontinued Planned Drug Administration | Rivaroxaban | 4 | Participants | ||
| Number of Participants Who Discontinued Planned Drug Administration | Apixaban | 2 | Participants | ||
| Number of Patients That Held Drug for Menorrhagia | Rivaroxaban | 0 | Participants | ||
| Number of Patients That Held Drug for Menorrhagia | Apixaban | 0 | Participants | ||
| Number of Participants With Major Hemorrhage | Rivaroxaban | 0 | Participants | ||
| Number of Participants With Major Hemorrhage | Apixaban | 0 | Participants | ||
| Number of Participants With Venous Thromboembolism (VTE) | Rivaroxaban | 0 | Participants | ||
| Number of Participants With Venous Thromboembolism (VTE) | Apixaban | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban | 8 | |
| Overall Study | STARTED | Apixaban | 11 | |
| Overall Study | COMPLETED | Rivaroxaban | 6 | |
| Overall Study | COMPLETED | Apixaban | 10 | |
| Overall Study | NOT COMPLETED | Rivaroxaban | 2 | |
| Overall Study | NOT COMPLETED | Apixaban | 1 |
Source ClinicalTrials.gov
Adverse events10
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 | Crossover to another anticoagulant | Blood and lymphatic system disorders | Rivaroxaban | 3 | 8 | 3 |
| other | Crossover to another anticoagulant | Blood and lymphatic system disorders | Apixaban | 1 | 11 | 1 |
| other | PBAC > 100 | Reproductive system and breast disorders | Rivaroxaban | 2 | 8 | 5 |
| other | PBAC > 100 | Reproductive system and breast disorders | Apixaban | 5 | 11 | 11 |
| other | Anticoagulant discontinued for more than 48 hours | Blood and lymphatic system disorders | Rivaroxaban | 1 | 8 | 1 |
| other | Anticoagulant discontinued for more than 48 hours | Blood and lymphatic system disorders | Apixaban | 1 | 11 | 1 |
| other | Worsening DVT | Vascular disorders | Rivaroxaban | 1 | 8 | 1 |
| other | Worsening DVT | Vascular disorders | Apixaban | 0 | 11 | 0 |
| other | Bleeding that causes unplanned visit to a healthcare provider | Blood and lymphatic system disorders | Rivaroxaban | 1 | 8 | 1 |
| other | Bleeding that causes unplanned visit to a healthcare provider | Blood and lymphatic system disorders | Apixaban | 0 | 11 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban | 0 | 8 |
| Total, all-cause mortality | Apixaban | 0 | 11 |
| Total, other adverse events | Rivaroxaban | 4 | 8 |
| Total, other adverse events | Apixaban | 5 | 11 |
| Total, serious adverse events | Rivaroxaban | 0 | 8 |
| Total, serious adverse events | Apixaban | 0 | 11 |
Source ClinicalTrials.gov
Papers9
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rivaroxaban vs Apixaban: Number of Participants Who Discontinued Planned Drug Administration | Trial comparisons |
| Rivaroxaban vs Apixaban: Number of Participants With Venous Thromboembolism (VTE) | Trial comparisons |
| Rivaroxaban vs Apixaban: Number of Patients That Held Drug for Menorrhagia | Trial comparisons |
| Rivaroxaban vs Apixaban: Number of Participants With Major Hemorrhage | Trial comparisons |
| Rivaroxaban vs Apixaban: Number of Participants Who Crossed Over to Another Anticoagulant | Trial comparisons |
| Rivaroxaban vs Apixaban: Number of Participants With Clinically Relevant Non-major Bleeding | Trial comparisons |
| Rivaroxaban vs Apixaban: deaths from any cause | Trial comparisons |
| Rivaroxaban vs Apixaban: serious adverse events | 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.
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/NCT02829957
GET https://conductscience.org/api/trials/v1/NCT02829957/registered