Using tranexamic acid to reduce bleeding from contraceptive implants
Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
This study is testing if a medication called tranexamic acid can help women who have heavy bleeding from contraceptive implants feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 15 Years to 45 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06000423 on ClinicalTrials.gov |
What this trial studies
This randomized double-blinded trial aims to evaluate the effectiveness of tranexamic acid (TXA) in treating menstrual changes caused by the etonogestrel subdermal contraceptive implant. Participants experiencing bothersome bleeding will be randomly assigned to receive either TXA or a placebo after three consecutive days of bleeding. They will track their bleeding patterns through an automated text message service, allowing for real-time data collection and monitoring. The study seeks to provide a potential solution for women affected by irregular bleeding associated with contraceptive use.
Who should consider this trial
Good fit: Ideal candidates are women who are English or Spanish speaking, in good health, and have an etonogestrel contraceptive implant with a history of frequent or prolonged bleeding.
Not a fit: Patients who are currently pregnant, less than 6 months postpartum, or have contraindications for contraceptive use will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for women experiencing heavy or irregular bleeding due to contraceptive implants.
How similar studies have performed: Other studies have explored the use of tranexamic acid for various bleeding conditions, suggesting potential efficacy, but this specific application for contraceptive-related bleeding is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Alison Edelman, MD, MPH — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Department of Ob/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.