Summary

Eligibility
for females ages 21-53 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Vanessa Jacoby, MD, MAS (ucsf)Alison Huang, MD, MAS (ucsf)
Headshot of Vanessa Jacoby
Vanessa Jacoby
Headshot of Alison Huang
Alison Huang

Description

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.

Official Title

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

Keywords

Leiomyoma, Uterine, Leiomyoma, Fibroid, Fibroid Uterus, Myofibroma, Letrozole, Letrozole 2.5mg

Eligibility

You can join if…

Open to females ages 21-53

  • 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 barrier method of contraception during the study period if at risk for pregnancy (any sexual activity with a non-sterile male partner)

You CAN'T join if...

  • Screening pelvic imaging indicating any leiomyomata ≥8 cm in maximum diameter, or uterine size ≥14 cm in length (equivalent to 14 weeks gestation)-note that candidates who exclusively have prior clinical pelvic imaging 12-24 months ago will be excluded if imaging includes leiomyomata ≥7 cm in maximum diameter, or uterine size ≥13 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)
  • Age ≥45 years with irregularly timed, heavy bleeding that has not yet been evaluated by endometrial biopsy, or endometrial biopsy indicating hyperplasia or malignancy
  • 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)

Locations

  • University of California, Sans Francisco accepting new patients
    San Francisco California 94115 United States
  • University of Mississippi Medical Center not yet accepting patients
    Jackson Mississippi 39216 United States

Lead Scientists at University of California Health

  • Vanessa Jacoby, MD, MAS (ucsf)
    Dr. Vanessa Jacoby is a Professor of Obstetrics, Gynecology, and Reproductive Sciences, the Associate Vice Chancellor for Clinical Research, and Director of the Clinical and Translational Science Institute. She is a clinical researcher with a focus on improving care for people with uterine fibroids.
  • Alison Huang, MD, MAS (ucsf)
    Dr. Alison Huang is Professor of Medicine, Urology, and Epidemiology & Biostatistics; Director of Research for General Internal Medicine at UCSF Health; Director of the UCSF Women's Health Clinical Research Center; and a clinical scientist dedicated to advancing scientific understanding and improving management of the impact of aging on women’s health and genitourinary health.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06143631
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 140 study participants
Last Updated