Clinical trial · Interventional
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Prospective Randomized Trial of Tranexamic Acid Versus Levonorgestrel Intrauterine System for the Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
NCT03317795CI-TRIAL-00055437completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized controlled trial (RCT) to assess the comparative effectiveness of Levonorgestrel Intrauterine System (LNG-IUS) to Tranexamic Acid (TA) for the treatment of heavy menstrual bleeding (HMB) in women with clinically-significant fibroids.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heavy Menstrual Bleeding | — | UNRESOLVED | — |
| Menorrhagia | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levonorgestrel IUS | Drug | — | UNRESOLVED |
| Tranexamic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Levonorgestrel IUS
- description
- Levonorgestrel-releasing intrauterine system (Mirena) contains 52 mg of levonorgestrel, a progestin, and is intended to provide an initial release of approximately 20 mcg/day. Levonorgestrel intrauterine system is effective immediately upon placement in the uterus and can be kept in place for up to 5 years.
- interventionNames
- Drug: Levonorgestrel IUS
- type
- ACTIVE_COMPARATOR
- label
- Tranexamic Acid
- description
- Tranexamic Acid (Lysteda) is an antifibrinolytic drug. Tranexamic Acid will be dosed at 1300mg by mouth three times a day at the start of menses and used during the days that bleeding is heaviest (not to exceed 5 days per menstrual cycle).
- interventionNames
- Drug: Tranexamic Acid
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women ages 25 -50 * Monthly menses * Image-confirmed uterine fibroids of at least 1 cm in size, either submucosal or intramural * Seeking treatment for heavy menstrual bleeding following completed clinical evaluation * Self-reported heavy menstrual bleeding for three months or longer * Completed evaluation for heavy menstrual bleeding within one year of study enrollment * Understands the English language for consent and questionnaires * Able and willing to provide informed consent Exclusion Criteria: * Class 0 fibroids confirmed by hysteroscopy, saline-infused sonogram, or 3D ultrasound * Uterine sounding length ≥ 14 cm * Uterine size ≥ 20 weeks gestational size * Abnormal endometrial biopsy or incomplete clinical testing to rule out malignancy * Needs or is using hormonal contraception, including estrogen-containing medications * Venous thromboembolic history, clotting disorder, or strong family history of venous thromboembolic events * Breast, uterine, or cervical malignancy * Liver disease or liver tumor * Pelvic inflammatory disease, gonorrhea or chlamydia infection during the past three months * Hemoglobin \< 8 mg/dL. For women with hemoglobin 8.0 - 12.0 mg/dL, iron supplement is recommended * Serum creatinine ≥ 1.4 * Current pregnancy or currently lactating
References
Publications (0)
Data not yet available
No reference posted for this study.