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Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

Primary Purpose

Bleeding, Contraceptive Device; Complications

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring Tranexamic Acid, Contraceptive Implant

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).

After three consecutive days of bleeding, five days of placebo three times per day.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
September 8, 2023
Sponsor
Oregon Health and Science University
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT06000423
Brief Title
Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
Official Title
Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

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
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Contraceptive Device; Complications
Keywords
Tranexamic Acid, Contraceptive Implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants assigned to either the TXA treatment group or the placebo group.
Masking
ParticipantInvestigator
Masking Description
double-blinded
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
After three consecutive days of bleeding, five days of placebo three times per day.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
TXA
Intervention Description
1300mg TXA taken three times per day for five days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo pills taken three times daily for five days.
Primary Outcome Measure Information:
Title
Amenorrhea days
Description
The difference in mean days without bleeding across 30-day reference period between the treatment and placebo groups.
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Women's Health Research Unit Department of Ob/Gyn
Phone
503-494-3666
Email
whru@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Edelman, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leo Han, MD, MCR
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

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