Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06000423
• Collaborator: Bill and Melinda Gates Foundation (Other)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Bleeding; Contraceptive Device; Complications	Drug: Tranexamic acid; Other: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants assigned to either the TXA treatment group or the placebo group.Participants assigned to either the TXA treatment group or the placebo group.
• Masking: Double (Participant, Investigator)
• Masking Description: double-blinded
• Primary Purpose: Treatment
• Official Title: Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).	Drug: Tranexamic acid; 1300mg TXA taken three times per day for five days; Other Names: TXA
Placebo Comparator: Placebo After three consecutive days of bleeding, five days of placebo three times per day.	Other: Placebo; Placebo pills taken three times daily for five days.

Outcome Measures

Primary Outcome Measures

1. Amenorrhea days [30 days]

   The difference in mean days without bleeding across 30-day reference period between the treatment and placebo groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University
• Bill and Melinda Gates Foundation

Investigators

• Principal Investigator: Alison Edelman, MD, MPH, Oregon Health and Science University
• Principal Investigator: Leo Han, MD, MCR, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alison Edelman, Principal Investigator, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT06000423
• Other Study ID Numbers: OHSU IRB 25761
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Alison Edelman, Principal Investigator, Oregon Health and Science University: Tranexamic Acid; Contraceptive Implant
• Additional relevant MeSH terms: Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Aug 21, 2023