Prescription of Letrozole for Uterine Myoma

NCT06143631 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 23-39255R01HD112465
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Uterine leiomyoma-related symptom severity over 12 weeks of treatment

  Change in Uterine Fibroid Symptoms Quality of Life (UFS-QOL) Symptom Severity Scale (SSS) score \[Range 8-40 with higher score indicating worse symptoms and worse outcomes\]

  Baseline to 12 weeks

Secondary Outcomes (10)

• Uterine leiomyoma-related quality of life over 12 weeks of treatment

  Baseline to 12 weeks

• Total leiomyoma volume over 12 weeks of treatment

  Baseline to 12 weeks

• Total uterine volume over 12 weeks of treatment

  Baseline to 12 weeks

• Symptoms of heavy menstrual bleeding

  Baseline to 12 weeks

• Improvement in Sexual Functioning

  Baseline to 12 weeks

Study Arms (2)

Letrozole

EXPERIMENTAL

Oral letrozole 2.5mg/day

Drug: Letrozole 2.5mg

Placebo and Letrozole

PLACEBO COMPARATOR

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

Drug: Letrozole 2.5mg; Other: Placebo

Interventions

Letrozole 2.5mg DRUG

Oral letrozole 2.5mg/day

Letrozole; Placebo and Letrozole

Placebo OTHER

Placebo capsule

Placebo and Letrozole

Eligibility Criteria

• Age: 21 Years - 53 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 regularly occurring menstrual periods of ≤ 14 days duration with a cycle of 21 to 38 days from the start of one menstrual period until the start of the next, by patient history for at least 3 months prior to screening
• 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)

You may not qualify if:

• 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; 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)
• Irregularly timed bleeding, including bleeding or spotting in between periods, in the past 3 months.
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (5)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94115, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vanessa Jacoby, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Alison Huang, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

(510) 788-0545; plumstudy@ucsf.edu

Lisa Abinanti

CONTACT

lisa.abinanti@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 22, 2023
• Study Start: July 24, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)