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Tranexamic Acid for Contraceptive-Related Bleeding

Phase 4

Recruiting

Led By Alison Edelman, MD, MPH

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have etonogestrel (ENG) subdermal contraceptive implant (must be palpable to prove that an ENG implant is in place at time of screening and enrollment)

English or Spanish speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial aims to find out if tranexamic acid is an effective treatment for irregular bleeding caused by contraceptive implant. Participants take TXA or placebo, and track their bleeding using text message.

Who is the study for?

This trial is for people in good health who experience frequent or prolonged bleeding with an ENG contraceptive implant and have been using it for at least 30 days. Participants must not be pregnant, less than 6 months postpartum, or have certain medical conditions like a history of blood clots or liver issues.Check my eligibility

What is being tested?

The study tests if Tranexamic Acid (TXA) can help manage irregular bleeding caused by the ENG contraceptive implant. Half of the participants will receive TXA while the other half will get a placebo, without knowing which one they're taking.See study design

What are the potential side effects?

Tranexamic Acid may cause side effects such as nausea, diarrhea, headaches, back pain, muscle cramps, allergic reactions or could increase the risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a palpable etonogestrel contraceptive implant.

Select...

I speak English or Spanish.

Select...

I have had long or frequent bleeding episodes with my ENG implant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Amenorrhea days

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116

22%

Readmissions

14%

Postoperative infections

10%

Re-operations

Thromboembolic events

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group

Tranexamic Group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).

Group II: PlaceboPlacebo Group1 Intervention

After three consecutive days of bleeding, five days of placebo three times per day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

2018

Completed Phase 4

~42540

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,864 Total Patients Enrolled

3 Trials studying Bleeding

177 Patients Enrolled for Bleeding

Bill and Melinda Gates FoundationOTHER

407 Previous Clinical Trials

22,924,040 Total Patients Enrolled

1 Trials studying Bleeding

5,646 Patients Enrolled for Bleeding

Alison Edelman, MD, MPHPrincipal InvestigatorOregon Health and Science University

7 Previous Clinical Trials

336 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility restricted to those over 60 years of age when it comes to this trial?

"According to the study's criteria, minors aged 15 and upwards can take part in this trial while people 45 years or older are ineligible."

Answered by AI

Has this course of action been granted regulatory acceptance by the FDA?

"This treatment has been given a score of 3 on the safety scale due to being in Phase 4, meaning that it is approved for public use."

Answered by AI

Are there any prerequisites to joining this medical study?

"Candidates aged between 15 and 45 that are suffering from bleeding can qualify for this trial. The recruitment effort is targeting a total of 48 participants."

Answered by AI

Is the enrollment process for this experiment still available?

"According to what is available on clinicaltrials.gov, this particular research project has halted its recruitment efforts as of September 8th 2023. Initially posted in November 1st of the same year, no new participants are being sought at present; however, there are 370 other medical studies that currently require volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

Alison Edelman 2024. "Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06000423.