Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-008671
    • Jacksonville, Florida: 16-008671
    NCT ID: NCT03317795
    Sponsor Protocol Number: 16-008671

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Premenopausal women aged 25-50.
  • Seeking treatment for HMB with a completed clinical evaluation.
  • Image-confirmed uterine fibroids of at least 1 cm in size and either submucosal or intramural.
  • Monthly menses.
  • Completed evaluation of HMB within one year.
  • Able to give consent for inclusion in the study.
  • Understands the English language for consent and questionnaires.
  • Self-reported HMB 3 months or more.
  • Not pregnant or breast-feeding.

Exclusion Criteria:

  • Class 0 fibroids confirmed by hysteroscopy, saline infused sonogram, or 3D ultrasound.
  • Uterine sounding length >14 cm.
  • Abnormal biopsy (pre-malignant or malignant) or incomplete clinical testing to rule out malignancy.
  • Venous thromboembolic history, clotting disorder, strong family history of venous thromboembolic events.
  • Needs hormonal contraception, including estrogen-containing medications.
  • Uterine size >20 weeks gestational size.
  • Breast, uterine or cervical malignancy.
  • Liver disease or liver tumor.
  • Pelvic inflammatory disease or infection with gonorrhea or chlamydia in last 3 months.
  • Hemoglobin less than 8mg/dL; for women 8-12 mg/dL recommend iron.
  • Serum creatinine ≥ 1.4.
  • Pregnant or breast-feeding.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shannon Laughlin-Tommaso, M.D.

Open for enrollment

Contact information:

Laura Akhtar CCRP

127or7839648

Akhtar.Laura@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Christopher Destephano, M.D., M.P.H.

Open for enrollment

Contact information:

Christopher Destephano M.D., M.P.H.

(904)953-2230

Destephano.Christopher@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20356720

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