Recruiting

LetrozolePrescription of Letrozole for Uterine Myoma

Sponsor:

UCLA

Code:

NCT06143631

Conditions

Leiomyoma, Uterine

Leiomyoma

Fibroid

Fibroid Uterus

Eligibility Criteria

Sex: Female

Age: 21 - 53

Healthy Volunteers: Accepted

Interventions

Letrozole 2.5mg

Placebo

Study Details

Brief 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.

Conditions

Leiomyoma, Uterine

Leiomyoma

Fibroid

Fibroid Uterus

Study ID

NCT06143631

Start date

Jul 24, 2024

Status verified date

Jul, 2026

Completion date

Dec 11, 2028

Anticipated

Primary completion date

Sep 11, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 21 - 53

Healthy Volunteers: Accepted

Inclusion Criteria:

At least 21 and less than 54 years of age (to focus on an adult, premenopausal population)
Female sex, based on sex identified on their birth certificate (no other gender requirements)
Have uterine leiomyomata that have been visualized on pelvic imaging (i.e., ultrasound or MRI) in the last 24 months
Report symptoms associated with leiomyomata such as heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, or dyspareunia for the past 3 months
Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of 30 or higher at baseline
Has had a menstrual period in the past 3 months (90 days)
Agree to use a non-hormonal or barrier method of contraception with any sexual activity with a non-sterile male partner during the study period (i.e., use of copper IUD is consistent with eligibility)

Exclusion Criteria:

Screening pelvic imaging indicating any leiomyomata ≥10 cm in maximum diameter, or uterine size ≥16 cm in length (equivalent to 16 weeks gestation)-note that candidates who exclusively have prior clinical pelvic imaging 12-24 months ago will be excluded if imaging includes leiomyomata ≥9 cm in maximum diameter, or uterine size ≥15 cm in length, presuming leiomyoma growth of ≥1 cm per year
Screening pelvic imaging indicating only one, sole leiomyoma <2 cm in maximum diameter
Any submucosal leiomyoma that is >50% within uterine cavity (FIGO Type 0 or Type 1 leiomyomata)
Visit to the emergency room or hospitalization for leiomyoma symptoms in the last 12 weeks
Leiomyomata treated by surgery, radiologic procedure in the last 12 weeks; or plans to undergo any of the above in the next 24 weeks
Leiomyomata treated by GRNH agonist or antagonist in the last 12 weeks (if injected) or in the last 4 weeks (if oral); or plans to use the above in the next 24 weeks
Currently pregnant or lactating, pregnant or lactating in the past 12 weeks, or planning to become pregnant in the next 24 weeks
Screening serum hemoglobin <8 g/dL, or history of blood transfusion in the last 12 weeks (indicating severe anemia)
Screening cholesterol lipid panel testing showing LDL cholesterol level ≥ 190 mg/dL (due to rare side effects over long-term use of aromatase inhibitors in postmenopausal women)
Screening serum estradiol level <30 pg/mL (consistent with postmenopausal status)
For women aged 45 years or older only: irregular menstrual cycles (menstrual cycles <21 days or >38 days between periods), prolonged menstrual bleeding (bleeding >14 days), or bleeding in between menstrual periods, unless already evaluated by a clinician to discuss endometrial biopsy (uterine biopsy) to rule out endometrial hyperplasia.
History of osteoporosis (based on self-reported DEXA indicating bone mineral density Z-score < -2.0 at spine, total hip, or femoral neck; a prior fracture judged to be a fragility fracture; or self-reported use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, or denosumab for bone density loss)
History of severe liver disease (Child Pugh Class C cirrhosis), posing safety risks for use of letrozole
Current or prior history of breast cancer (given potential need to take letrozole for breast cancer treatment or secondary prevention)
Screening pelvic imaging indicating an Ovarian-Adnexal Reporting and Data System (O-RADS) category 3, 4, or 5 ovarian or adnexal lesion
Screening pelvic imaging concerning for other current cancer of the gynecologic, genitourinary or gastrointestinal system
Prior hypersensitivity or significant adverse reaction to letrozole or any aromatase inhibitor, or to an ingredient in the placebo capsule
Use of letrozole, other aromatase inhibitor, or selective estrogen receptor modulator (SERM) medications in the past 4 weeks, or existing plans to initiate one of these in the next 24 weeks
Use of oral, vaginal, or topical exogenous estrogen, progestin, or androgen therapy in the past 4 weeks; or injectable forms of the above in the past 12 weeks; or plans to initiate any of the above in the next 24 weeks
Use of medications with potential unsafe interactions with letrozole in the past 4 weeks (methadone, levomethadone, nintedanib, thalidomide), or plans to initiate these in the next 24 weeks
Any condition that, in the opinion of the investigators, would interfere with ability to complete study procedures, including acute or uncontrolled mental health condition, substance abuse, or inability to complete procedures in English (or Spanish, for sites that offer study assessments in Spanish)

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Letrozole

Oral letrozole 2.5mg/day

placebo comparator: Placebo and Letrozole

Placebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks

Interventions

Letrozole 2.5mg

Oral letrozole 2.5mg/day

Placebo

Placebo capsule

Primary outcome measure

Uterine leiomyoma-related symptom severity over 12 weeks of treatment [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Study Coordinator

(510) 788-0545 plumstudy@ucsf.edu

Lisa Abinanti

lisa.abinanti@ucsf.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Study Coordinator

310-794-3467 sfkhan@mednet.ucla.edu

Principal Investigator:

Ram Parvataneni, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Maria Tolentino

plumstudy@ucsf.edu

Yulissa Oceguera-Barragan

plumstudy@ucsf.edu

Principal Investigator:

Vanessa L Jacoby, MD, MAS

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Research Coordinator

507-422-3984 Wroblewski.stacy@mayo.edu

Principal Investigator:

Sarah Rassier, MD

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Study Coordinator

601-984-6628 lmelaku@umc.edu

Principal Investigator:

Kedra Wallace, PhD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Study Coordinator

919-681-0308 caroline.nagle@duke.edu

Principal Investigator:

Craig Sobolewski, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-22.