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
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 StatesActive - Recruiting
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