Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects (NCT06000423) | Clinical Trial Compass
CompletedPhase 4
Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
United States65 participantsStarted 2024-01-23
Plain-language 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
Who can participate
Age range15 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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