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RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding

NCT02829957 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-11-13

Study results available
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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.

Conditions

  • Venous Thromboembolism
  • Menstruation

Interventions

DRUG

Apixaban

10mg BID for 7 days, then 5mg BID for three months

DRUG

Rivaroxaban

15mg BID for 7 days, then 20mg daily for three months

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Jeffrey A Kline, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-02-13
Completion
2020-02-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02829957 on ClinicalTrials.gov