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Hormone Therapy

Letrozole for Uterine Fibroids (PLUM Trial)

Phase 4

Waitlist Available

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 24 weeks

Awards & highlights

PLUM Trial 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.Check my eligibility

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.See study design

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.

PLUM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience heavy bleeding, pelvic discomfort, or pain during sex due to fibroids.

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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.

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I am between 21 and 54 years old.

PLUM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in fibroid symptom severity

Side effects data

From 2011 Phase 2 trial • 160 Patients • NCT00867217

13%

Joint Function

Arthralgia

Joint Pain

Fatigue

Nausea

Hot Flashes

Pain - Back

Pain - Hip

Cardiac Changes

Supraventricular arryhthmia

Wound Complications

100%

80%

60%

40%

20%

Study treatment Arm

Vitamin D

Placebo

PLUM Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LetrozoleExperimental Treatment1 Intervention

Oral letrozole 2.5mg/day

Group II: Placebo and LetrozolePlacebo Group1 Intervention

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

~840

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,967 Previous Clinical Trials

2,672,757 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,400 Total Patients Enrolled

Vanessa Jacoby, MD, MASPrincipal InvestigatorUniversity of California, San Francisco

2 Previous Clinical Trials

1,433 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Letrozole a viable and secure option for patients?

"Our team at Power gave Letrozole a score of 3, as it is already approved in the fourth stage of clinical trials."

Answered by AI

Would I qualify to join this research endeavor?

"Entry into this clinical trial requires patients to be between 21 and 54 years old, with a diagnosis of fibroid. The recruitment process is seeking 140 individuals in total."

Answered by AI

Can adults over the age of twenty participate in this experiment?

"To be included in this clinical trial, patients must fall within the age parameters of 21 to 54. There is also a separate study for individuals under 18 and another trial open to those over 65 years old."

Answered by AI

Are there still openings available to participate in this trial?

"Information available on clinicaltrials.gov illustrates that this trial has ceased recruitment efforts, with the initial posting dated March 1st 2024 and last update registered as November 15th 2023. Notwithstanding, 50 alternative trials are presently recruiting patients to join their research endeavours."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prescription of Letrozole for Uterine Myoma

2024. "Prescription of Letrozole for Uterine Myoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06143631.

All > Uterine Fibroids