Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

NCT ID: NCT06000423

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2025-08-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

1300mg TXA taken three times per day for five days

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo pills taken three times daily for five days.

Interventions

Tranexamic acid

1300mg TXA taken three times per day for five days

Intervention Type: DRUG

Placebo

Placebo pills taken three times daily for five days.

Intervention Type: OTHER

Other Intervention Names

TXA

Eligibility Criteria

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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Alison Edelman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison Edelman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Leo Han, MD, MCR

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU IRB 25761

Identifier Type: -

Identifier Source: org_study_id