COMPLETED

Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

Conditions

Bleeding Contraceptive Device; Complications Tranexamic Acid Contraceptive Implant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

Quick Facts

Study Start:2024-01-23

Study Completion:2025-08-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06000423

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Principal Investigator

Alison Edelman, MD, MPH

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Leo Han, MD, MCR

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Alison Edelman, MD, MPH, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University
Leo Han, MD, MCR, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-23

Study Completion Date2025-08-14

Study Record Updates

Study Start Date2024-01-23

Study Completion Date2025-08-14

Terms related to this study

Keywords Provided by Researchers

Tranexamic Acid
Contraceptive Implant

Additional Relevant MeSH Terms

Bleeding
Contraceptive Device; Complications