- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06143631
Prescription of Letrozole for Uterine Myoma (PLUM)
November 15, 2023 updated by: University of California, San Francisco
Letrozole for Treatment of Uterine Fibroids: A Randomized, Placebo-Controlled Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vanessa Jacoby, MD, MAS
- Phone Number: 415-514-8299
- Email: vanessa.jacoby@ucsf.edu
Study Contact Backup
- Name: Lisa Abinanti
- Email: lisa.abinanti@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- University of California, Sans Francisco
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
-
Contact:
- Kedra Williams, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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, dyspareunia, with UFS-QOL SSS score of at least 30 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)
Exclusion Criteria:
- 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 with 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
- 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
- Any submucosal leiomyoma >1cm that is >50% within uterine cavity (FIGO Type 0 or Type 1 leiomyomata) amenable to hysteroscopic resection
- Currently pregnant or lactating, pregnant or lactating in the past 12 weeks, or planning to become pregnant in the next 24 weeks
- Hemoglobin <8 g/dL or required blood transfusion in the last 12 weeks
- Visit to the emergency room or hospitalization for leiomyoma symptoms in the last 12 weeks
- 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, or based on a fracture judged to be a fragility fracture) or self-reported history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss
- Serum LDL cholesterol >160 mg/dL (due to rare side effects over long-term use of aromatase inhibitors reported in postmenopausal women with breast cancer)
- History of severe liver disease (Child Pugh Class C cirrhosis)
- Current or prior history of breast cancer
- Pelvic imaging concerning for 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 plans to initiate in the next 24 weeks
- Use of exogenous estrogen, progestin, or androgen therapy in the past 4 weeks, or plans to initiate 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Letrozole
Oral letrozole 2.5mg/day
|
Oral letrozole 2.5mg/day
|
Placebo Comparator: Placebo and Letrozole
Placebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks
|
Placebo capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fibroid symptom severity
Time Frame: Baseline to 12 weeks
|
Change in UFS-Qol Symptom Severity Score from Baseline to 12 Weeks.
|
Baseline to 12 weeks
|
Change in fibroid symptom severity
Time Frame: Baseline to 24 weeks
|
Change in UFS-Qol Symptom Severity Score from Baseline to 24 Weeks.
|
Baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Vanessa Jacoby, MD, MAS, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
November 15, 2023
First Submitted That Met QC Criteria
November 15, 2023
First Posted (Estimated)
November 22, 2023
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Connective Tissue Diseases
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Leiomyoma
- Myofibroma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
Other Study ID Numbers
- 23-39255
- R01HD112465 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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