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Pilot of Letrozole for Uterine Myomas (PLUM)

Primary Purpose

Leiomyoma, Uterine Fibroids

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Letrozole

Placebo

About this trial

This is an interventional treatment trial for Leiomyoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

≥21 years old
Premenopausal (at least one menses in last 3 months)
Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)
Fibroids that are ≤4 in total number or Fibroids that are ≤7 in total number if all fibroids are less than 4cm (40 mm) each
Fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid >2cm)
Up to date in Pap smear screening and surveillance
Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells
Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy
Has primary care provider or gynecologist
Agrees not to start new medications/treatments for fibroids during the study
Able to give informed consent

Exclusion Criteria:

Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months
Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection
Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months)
Pregnant, lactating, or planning to become pregnant in the next 6 months
Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo)
History of osteopenia or osteoporosis
History of hyperlipidemia
Current liver or kidney disease
Unable or unwilling to attend 4 study visits
Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system
Does not have primary care provider or gynecologist

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Letrozole

Placebo and Letrozole

Arm Description

Oral letrozole 2.5mg/day

Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months

Outcomes

Primary Outcome Measures

Changes in Fibroid-related Symptoms After Treatment With Letrozole

The Uterine Fibroid Sympton and Quality of Life (UFS-QoL) Symptom Severity score measures self-reported severity of fibroid-related symptoms. Symptoms include: fatigue, sleep, self-image, mood disturbances/psychologic distress, fear of embarrassment, interference with daily activities, relationships with family and friends, and sexual functioning. Scores range from 0 to 100; higher scores indicate greater symptom severity.

Secondary Outcome Measures

Full Information

NCT ID

NCT02470741

First Posted

June 4, 2015

Last Updated

November 4, 2019

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02470741

Brief Title

Pilot of Letrozole for Uterine Myomas

Acronym

PLUM

Official Title

Pilot of Letrozole for Uterine Myomas

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole 2.5mg/day and an identical placebo capsule (Group B).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leiomyoma, Uterine Fibroids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Letrozole

Arm Type

Experimental

Arm Description

Oral letrozole 2.5mg/day

Arm Title

Placebo and Letrozole

Arm Type

Placebo Comparator

Arm Description

Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months

Intervention Type

Drug

Intervention Name(s)

Letrozole

Other Intervention Name(s)

Femara

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Changes in Fibroid-related Symptoms After Treatment With Letrozole

Description

Time Frame

Baseline to 2 Months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥21 years old Premenopausal (at least one menses in last 3 months) Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia) Fibroids that are ≤4 in total number or Fibroids that are ≤7 in total number if all fibroids are less than 4cm (40 mm) each Fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid >2cm) Up to date in Pap smear screening and surveillance Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy Has primary care provider or gynecologist Agrees not to start new medications/treatments for fibroids during the study Able to give informed consent Exclusion Criteria: Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months) Pregnant, lactating, or planning to become pregnant in the next 6 months Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo) History of osteopenia or osteoporosis History of hyperlipidemia Current liver or kidney disease Unable or unwilling to attend 4 study visits Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system Does not have primary care provider or gynecologist

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vanessa Jacoby, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

12. IPD Sharing Statement

Links:

URL

https://clinicaltrials.ucsf.edu/fibroids

Description

Fibroid Trials at UCSF

Learn more about this trial

Pilot of Letrozole for Uterine Myomas

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