Phase
Condition
Hemorrhage
Treatment
Tranexamic acid
Placebo
Clinical Study ID
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 adaily text 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 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 dailyor >= 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 couldhave used Cannabidiol, THC, or marijuana chronically in the past, but must have awashout 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 usedcigarettes chronically in the past, but must have a washout time period of no usefor at least six months prior to the study)
Study Design
Connect with a study center
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
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