Phase 4 N=18 Randomized Treatment

Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids

Heavy Menstrual Bleeding · Menorrhagia · Uterine Fibroids

Bottom Line

View on ClinicalTrials.gov: NCT03317795 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcome: Primary: Change in Self-Reported Menorrhagia Scores — 59.1; 25.4 score on a scale — p=0.11

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levonorgestrel IUS (Drug); Tranexamic Acid (Drug)
Age: Adult · 25+ yrs
Sex: Female
Sponsor: Shannon K. Laughlin-Tommaso
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Self-Reported Menorrhagia Scores	59.1; 25.4	0.11
PRIMARY Number of Participants to Complete Study	7; 2	—
SECONDARY Change in Pain Score	-57.5; 0	0.64
SECONDARY Change in Quality of Life	11.1; 1.7; -1.0; 3.3	0.32
SECONDARY Change in Quality of Life, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)	32.8; 21.6	0.33
SECONDARY Change in Symptoms, as Measured by the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)	-28.1; -15.6	0.40
SECONDARY Change in Fibroid Size	3; 10.5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03317795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.