Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

NCT06000423 | Completed Phase 4 FDA Drug

• 1 other identifier: OHSU IRB 25761
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tranexamic Acid; Contraceptive Implant

Outcome Measures

Primary Outcomes (1)

• Amenorrhea days

  The difference in mean days without bleeding across 30-day reference period between the treatment and placebo groups.

  30 days

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Tranexamic acid DRUG

1300mg TXA taken three times per day for five days

Also known as: TXA

Treatment

Placebo OTHER

Placebo pills taken three times daily for five days.

Placebo

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Alison Edelman, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Leo Han, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants assigned to either the TXA treatment group or the placebo group.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: January 23, 2024
• Primary Completion: August 13, 2025
• Study Completion: August 14, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)