Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

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

Study Overview

• Status: Completed
• Conditions: Bleeding; Contraceptive Device; Complications
• Intervention / Treatment: Drug: Tranexamic acid; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English or Spanish speaking
• In good general health
• Have etonogestrel (ENG) subdermal contraceptive implant (must be palpable to prove that an ENG implant is in place at time of screening and enrollment)
• Experience frequent or prolonged bleeding while using ENG implant (>7 days of continuous bleeding/spotting in the last 30 days, or 2 or more episodes of bleeding/spotting in the last 30 days)
• Implant use for at least 30 days prior to screening visit
• Willing to continue using the implant for at least 30 days from study enrollment
• Access to a reliable cell phone and must be willing to receive and respond to a daily text or email message to assess bleeding and use of study drug
• Negative gonorrhea/chlamydia screening performed at screening visit

Exclusion Criteria:

• Centers for Disease Control Medical Eligibility for Contraceptive use category 3 or 4 for contraceptive usage
• Currently pregnant
• Less than 6 months postpartum, less than 6 weeks abortion, not breast/chest feeding (cessation of lactation at least 6 weeks prior to enrollment)
• Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
• Bleeding dyscrasia
• Anticoagulation use
• Active cervicitis
• Allergy to Tranexamic Acid
• Known renal insufficiency
• History of venous thromboembolism
• Current or past breast or uterine malignancy
• Concurrent use of P450 pathway inducing drug
• Implant is due to be switched out in 2 months or less from enrollment
• Routine or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs once daily or >= 14 days per month)
• Currently using oral contraceptives in addition to implant (to be eligible, needs to have 4-6 week washout period)
• Prior pregnancy occurred while Nexplanon/Implanon was in place
• Chronic use of Cannabidiol, THC, or marijuana (>3 times per week) (patients could have used Cannabidiol, THC, or marijuana chronically in the past, but must have a washout time period of no use for at least one month prior to the study)
• Chronic use of cigarettes (>1 cigarette per week) (patients could have used cigarettes chronically in the past, but must have a washout time period of no use for at least six months prior to the study)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).	Drug: Tranexamic acid; 1300mg TXA taken three times per day for five days; Other Names: TXA
Placebo Comparator: Placebo; After three consecutive days of bleeding, five days of placebo three times per day.	Other: Placebo; Placebo pills taken three times daily for five days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amenorrhea days	The difference in mean days without bleeding across 30-day reference period between the treatment and placebo groups.	30 days

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Alison Edelman, MD, MPH, Oregon Health and Science University; Principal Investigator: Leo Han, MD, MCR, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): August 13, 2025
• Study Completion (Actual): August 14, 2025

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Tranexamic Acid; Contraceptive Implant
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: OHSU IRB 25761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No