MedTrace Logo

Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

NCT03317795 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-12-08

Study results available
· View outcomes & findings →

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 bleeding (HMB) in women with clinically-significant fibroids.

Conditions

  • Heavy Menstrual Bleeding
  • Menorrhagia
  • Uterine Fibroids

Interventions

DRUG

Levonorgestrel IUS

LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density.

DRUG

Tranexamic Acid

Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Shannon K. Laughlin-Tommaso

    lead OTHER

Principal Investigators

  • Shannon K Laughlin-Tommaso, MD, MPH · Mayo Clinic

  • Christopher C Destephano, MD, MPH · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2020-12-28
Completion
2020-12-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03317795 on ClinicalTrials.gov