Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

NCT03317795 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 16-008671R21HD091337
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Conditions

Heavy Menstrual Bleeding; Menorrhagia; Uterine Fibroids

Keywords

Menorrhagia; FIbroids; Menstrual Bleeding; Heavy Bleeding; Menses; Uterine Fibroids

Outcome Measures

Primary Outcomes (2)

• Change in Self-Reported Menorrhagia Scores

  The Menorrhagia Multi-Attribute Scale (MMAS) questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).

  Baseline, 3 months

• Number of Participants to Complete Study

  Total number of study participants to complete assigned treatment.

  9 months

Secondary Outcomes (5)

• Change in Pain Score

  Baseline, 3 months

• Change in Quality of Life

  Baseline, 3 months

• Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)

  Baseline, 3 months

• Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)

  Baseline, 3 months

• Change in Fibroid Size

  9 months

Study Arms (2)

Levonorgestrel IUS

ACTIVE COMPARATOR

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.

Drug: Levonorgestrel IUS

Tranexamic Acid

ACTIVE COMPARATOR

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).

Drug: Tranexamic Acid

Interventions

Levonorgestrel IUS DRUG

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.

Also known as: Mirena IUS

Levonorgestrel IUS

Tranexamic Acid DRUG

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.

Also known as: Lysteda

Tranexamic Acid

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shannon K. Laughlin-Tommaso: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Mayo Clinic in Jacksonville, Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Menorrhagia; Leiomyoma

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Shannon K. Laughlin-Tommaso
• Organization: Mayo Clinic

LaughlinTommaso.Shannon@mayo.edu

507-538-5783

Study Officials

• Shannon K Laughlin-Tommaso, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Christopher C Destephano, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 23, 2017
• Study Start: November 14, 2017
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2020
• Last Updated: December 8, 2021
• Results First Posted: December 8, 2021

Record last verified: 2021-11

Locations

US (2)