BleedingPhase 4NCT06000423

Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

A Phase 4 study testing Tranexamic acid in people with Bleeding and Contraceptive Device; Complications, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 45 years, women only
Conditions the study is for: Bleeding, Contraceptive Device; Complications
What is being tested?: Tranexamic acid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 23 Jan 2024to 14 Aug 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 45 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Show all 18Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

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
Being tested: Tranexamic acid, Placebo
Keywords: Tranexamic Acid, Contraceptive Implant
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tranexamic acidDrug
Also called TXA
1300mg TXA taken three times per day for five days
PlaceboOther
Placebo pills taken three times daily for five days.

Study groups in NCT06000423
Study group	Role	What they receive
Treatment	Experimental	After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID). Receives: Drug: Tranexamic acid
Placebo	Placebo comparator	After three consecutive days of bleeding, five days of placebo three times per day. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 202414 Aug 2025

First posted21 Aug 2023
Study start23 Jan 2024
Primary completion13 Aug 2025
Study completion14 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BleedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants assigned to either the TXA treatment group or the placebo group.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06000423
Sponsor's protocol ID: STUDY00025761
Status last verified: Oct 2026
First submitted: 14 Aug 2023
Last updated: 15 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
ClinicalTrials.gov ID: NCT06000423
Acronym / sponsor ID: STUDY00025761
Conditions: Bleeding, Contraceptive Device; Complications
Keywords: Tranexamic Acid, Contraceptive Implant
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: Bill and Melinda Gates Foundation
Study start: 23 Jan 2024 (actual)
Primary completion: 13 Aug 2025 (actual)
Study completion: 14 Aug 2025 (actual)
First posted: 21 Aug 2023 (actual)
Results: Posted 15 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Participants assigned to either the TXA treatment group or the placebo group.

Arm	Type	Receives
Treatment	Experimental	Drug: Tranexamic acidAfter three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).
Placebo	Placebo comparator	Other: PlaceboAfter three consecutive days of bleeding, five days of placebo three times per day.

Who may qualify

Ages: 15 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tranexamic acidAlso: TXA1300mg TXA taken three times per day for five days	Drug	Treatment
PlaceboPlacebo pills taken three times daily for five days.	Other	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 15 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	34	27
Treatment	31	27

Primary outcome: Amenorrhea Days

Time frame: 30 days. Median (Inter-Quartile Range). Unit: days

Measure	Placebo n = 27	Treatment n = 27
Value	19 (14 to 23)	19 (10 to 21)

Placebo vs Treatment: Median Difference (Final Values): 0, p = 0.381, Wilcoxon (Mann-Whitney)

Population analysed: participants who were terminated due to no bleeding during the first 30 days following enrollment, as well as those who were non-compliant after 4 and 5 days are excluded

Adverse events

Time frame: from study enrollment through follow-up, roughly 60 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Treatment	0 of 31 (0%)	1 of 31 (3.2%)	0 of 31

Limitations and caveats (from the sponsor): We used a 5-day TID course of 1300 mg TXA, the same dose used in HMB. It is possible that an alternative dosing regimen (ie, longer treatment length or higher dose) may have been more successful. Our study did observe some noncompliance.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison Edelman, MD, MPH principal investigator

Oregon Health and Science University

Leo Han, MD, MCR principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic acid in people with Bleeding and Contraceptive Device; Complications, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amenorrhea Days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06000423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.