Clinical trial NCT06000423: Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
Official title: Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bleeding
Contraceptive Device; Complications
Keywords: Tranexamic Acid
Contraceptive Implant
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2023-08-21
Enrollment: 48
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants assigned to either the TXA treatment group or the placebo group.
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Amenorrhea days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Leo Han, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References: