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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | After three consecutive days of bleeding, five days of 1300mg TXA three times per day (TID). |
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| Placebo | Placebo Comparator | After three consecutive days of bleeding, five days of placebo three times per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 1300mg TXA taken three times per day for five days |
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| Measure | Description | Time Frame |
|---|---|---|
| Amenorrhea days | The difference in mean days without bleeding across 30-day reference period between the treatment and placebo groups. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Edelman, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Leo Han, MD, MCR | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Participants assigned to either the TXA treatment group or the placebo group.
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double-blinded
| Placebo | Other | Placebo pills taken three times daily for five days. |
|