Trial Title:
Prescription of Letrozole for Uterine Myoma
NCT ID:
NCT06143631
Condition:
Leiomyoma, Uterine
Leiomyoma
Fibroid
Fibroid Uterus
Conditions: Official terms:
Leiomyoma
Myofibroma
Letrozole
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Letrozole 2.5mg
Description:
Oral letrozole 2.5mg/day
Arm group label:
Letrozole
Arm group label:
Placebo and Letrozole
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo capsule
Arm group label:
Placebo and Letrozole
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.
Criteria for eligibility:
Criteria:
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 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)
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; 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
- 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)
Gender:
Female
Minimum age:
21 Years
Maximum age:
53 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maria Tolentino
Email:
plumstudy@ucsf.edu
Contact backup:
Last name:
Yulissa Oceguera-Barragan
Email:
plumstudy@ucsf.edu
Investigator:
Last name:
Vanessa L Jacoby, MD, MAS
Email:
Principal Investigator
Investigator:
Last name:
Alison Huang, MD, MAS
Email:
Principal Investigator
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shauna Spencer
Contact backup:
Last name:
Sheila Belk
Investigator:
Last name:
Kedra Wallace, PhD
Email:
Principal Investigator
Investigator:
Last name:
Elizabeth Lutz, MD
Email:
Sub-Investigator
Start date:
July 24, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Agency class:
NIH
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06143631
