Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

Last updated: April 1, 2024
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

4

Condition

Hemorrhage

Treatment

Placebo

Tranexamic acid

Clinical Study ID

NCT06000423
OHSU IRB 25761
  • Ages 15-45
  • Female

Study 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

Inclusion Criteria:

  • English or Spanish speaking
  • In good general health
  • Have etonogestrel (ENG) subdermal contraceptive implant (must be palpable to provethat an ENG implant is in place at time of screening and enrollment)
  • Experience frequent or prolonged bleeding while using ENG implant (>7 days ofcontinuous bleeding/spotting in the last 30 days, or 2 or more episodes ofbleeding/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 dailytext or email message to assess bleeding and use of study drug
  • Negative gonorrhea/chlamydia screening performed at screening visit

Exclusion

Exclusion Criteria:

  • Centers for Disease Control Medical Eligibility for Contraceptive use category 3 or 4for 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 tohave 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 haveused Cannabidiol, THC, or marijuana chronically in the past, but must have a washouttime 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 cigaretteschronically in the past, but must have a washout time period of no use for at leastsix months prior to the study)

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
January 23, 2024
Estimated Completion Date:
January 01, 2026

Connect with a study center

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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