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Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

NCT06000423 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-08-19

No results posted yet for this study

Summary

This randomized double blinded trial seeks to determine whether tranexamic acid (TXA) is an efficacious treatment for contraceptive induced menstrual changes (CIMC) including irregular, bothersome bleeding caused by the etonogestrel subdermal contraceptive implant (ENG implant). Participants will be randomized into the TXA treatment arm or a placebo. They will begin taking the medication after three consecutive days of bleeding. Participants will track their bleeding using an automated text message service

Conditions

  • Bleeding
  • Contraceptive Device; Complications

Interventions

DRUG

Tranexamic acid

1300mg TXA taken three times per day for five days

OTHER

Placebo

Placebo pills taken three times daily for five days.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Alison Edelman, MD, MPH · Oregon Health and Science University

  • Leo Han, MD, MCR · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2025-08-13
Completion
2025-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06000423 on ClinicalTrials.gov