RecruitingPhase 4NCT06143631

Prescription of Letrozole for Uterine Myoma

Letrozole for Treatment of Uterine Fibroids: A Randomized, Placebo-Controlled Trial


Sponsor

University of California, San Francisco

Enrollment

140 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 53 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether letrozole — a medication typically used to treat breast cancer — can help shrink uterine fibroids (noncancerous growths in the uterus) and reduce symptoms like heavy periods and pelvic pain in premenopausal women. **You may be eligible if...** - You are a woman between 21 and 53 years old - You have fibroids confirmed by ultrasound or MRI in the last 2 years - You have moderate-to-severe symptoms from your fibroids (heavy bleeding, pressure, pain) - You have regular menstrual cycles - You are willing to use non-hormonal contraception during the study **You may NOT be eligible if...** - You have a very large fibroid or a very large uterus - You have a fibroid that is mostly inside the uterine cavity - You have been hospitalized recently for fibroid symptoms - You recently had surgery or treatment for fibroids - You are pregnant, breastfeeding, or planning to become pregnant soon - You have osteoporosis or very low bone density - You have a history of breast cancer - You have severe liver disease - You have used hormonal therapies or aromatase inhibitors recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLetrozole 2.5mg

Oral letrozole 2.5mg/day

OTHERPlacebo

Placebo capsule


Locations(5)

University of California, Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Duke University

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06143631


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