Phase 3 Completed N=19 Randomized Treatment

RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding

Venous Thromboembolism · Menstruation

Source: ClinicalTrials.gov NCT02829957 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcomePrimary: PBAC Scores — 292; 146 score on a scale

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

A large proportion of women with menstruating potential with newly diagnosed VTE or atrial fibrillation, treated with apixaban will have less menstrual blood loss than patients randomized to rivaroxaban.

Outcome Measures

Outcome	Result	p-value
PRIMARY PBAC Scores	292; 146	—
SECONDARY Number of Participants Who Discontinued Planned Drug Administration	4; 2	—
SECONDARY Number of Patients That Held Drug for Menorrhagia	0; 0	—
SECONDARY Number of Participants With Major Hemorrhage	0; 0	—
SECONDARY Number of Participants With Venous Thromboembolism (VTE)	0; 0	—
SECONDARY Number of Participants Who Crossed Over to Another Anticoagulant	3; 1	—
SECONDARY Number of Participants With Clinically Relevant Non-major Bleeding	3; 0	—
SECONDARY Hemoglobin Concentration	12.8; 13.25	—
SECONDARY Physical Component Summary of Standard From 36	55.5; 45.6	—

Eligibility Criteria

Inclusion Criteria

Non-pregnant women, age 18-50
For study purposes, evidence of negative pregnancy is accounted for by the treating physician's initiation of treatment with oral anticoagulants
Objectively diagnosed VTE or atrial fibrillation/flutter
Patient reported active menstruation - does not apply to women who were recently pregnant
Clinical plan and patient agreement to treat with oral anticoagulation for 3 months or longer
Patients must have a working telephone

Exclusion Criteria

Package insert exclusions for Eliquis (Apixban) or Xarelto (Rivaroxaban): [active pathological bleeding or severe hypersensitivity reaction to XARELTO or ELIQUIS (e.g., anaphylactic reactions)]
Plan to become pregnant in the next three months.
Concomitant prescribed use of aspirin or thienopyridenes or other platelet inhibiting drugs
Plan for surgical hysterectomy or endometrial ablation
Known uterine cancer
Von Willebrand's disease, or hemophilia
Known coagulopathy from liver disease
Conditions likely to preclude adherence to study procedures: Active intravenous drug use, known alcoholism, homelessness, or uncontrolled psychiatric illness.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02829957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.