Status:
COMPLETED
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
Lead Sponsor:
Shannon K. Laughlin-Tommaso
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Heavy Menstrual Bleeding
Menorrhagia
Eligibility:
FEMALE
25-50 years
Phase:
PHASE4
Brief Summary
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 bleedin...
Detailed Description
Uterine fibroids are common and debilitating problem for some women. Nearly 60% of women with fibroids report that symptoms affect their quality of life and impede physical activity, and 24% report th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03317795
Start Date
November 14 2017
End Date
December 28 2020
Last Update
December 8 2021
Active Locations (2)
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1
Mayo Clinic in Jacksonville, Florida
Jacksonville, Florida, United States, 32224
2
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States, 55905