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Hormone Therapy

Letrozole for Uterine Fibroids (PLUM Trial)

Phase 4
Recruiting
Led By Vanessa Jacoby, MD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing a medication to see if it can help reduce symptoms and size of leiomyomas (uterine fibroids).

Who is the study for?
This trial is for premenopausal women aged 21-54 who have confirmed uterine fibroids with symptoms like heavy bleeding, pelvic discomfort, or urinary issues. Participants must have regular menstrual cycles and agree to use non-hormonal contraception if sexually active.
What is being tested?
The PLUM Study is testing the effectiveness of Letrozole (2.5mg) compared to a placebo in reducing symptoms related to uterine fibroids and improving quality of life, as well as decreasing the size of leiomyoma and the uterus itself.
What are the potential side effects?
Potential side effects from Letrozole may include hot flashes, joint pain, fatigue, increased sweating, nausea and dizziness. Since it's being compared with a placebo, some participants won't experience these but will be monitored for any reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience heavy bleeding, pelvic discomfort, or pain during sex due to fibroids.
Select...
My menstrual cycles are regular, lasting 21 to 38 days and no longer than 14 days for the last 3 months.
Select...
I am a female as per my birth certificate.
Select...
I am between 21 and 54 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Uterine leiomyoma-related symptom severity over 12 weeks of treatment
Secondary study objectives
Effect of letrozole on frequency of hot flashes
Effect of letrozole on serum cholesterol levels
Effect of letrozole on serum estradiol levels
+7 more

Side effects data

From 2011 Phase 2 trial • 160 Patients • NCT00867217
13%
Joint Function
9%
Arthralgia
8%
Joint Pain
8%
Fatigue
6%
Nausea
4%
Hot Flashes
4%
Pain - Back
1%
Pain - Hip
1%
Cardiac Changes
1%
Supraventricular arryhthmia
1%
Wound Complications
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Vitamin D

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LetrozoleExperimental Treatment1 Intervention
Oral letrozole 2.5mg/day
Group II: Placebo and LetrozolePlacebo Group2 Interventions
Placebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole 2.5mg
2019
Completed Phase 4
~1490

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,314 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,810 Total Patients Enrolled
Vanessa Jacoby, MD, MASPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
1,433 Total Patients Enrolled
Alison Huang, MD, MASPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
379 Total Patients Enrolled
~93 spots leftby Jan 2027
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