Pilot of Letrozole for Uterine Myomas

NCT02470741 | Completed Phase 4 Results DMC

• 1 other identifier: 15-15678
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Leiomyoma; Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 2 Months

Study Arms (2)

Letrozole

EXPERIMENTAL

Oral letrozole 2.5mg/day

Drug: Letrozole

Placebo and Letrozole

PLACEBO COMPARATOR

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

Drug: Letrozole; Other: Placebo

Interventions

Letrozole DRUG

Also known as: Femara

Letrozole; Placebo and Letrozole

Placebo OTHER

Placebo and Letrozole

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Links

• Fibroid Trials at UCSF

MeSH Terms

Conditions

Leiomyoma

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lisa Abinanti, Project Director
• Organization: University of California, San Francisco

lisa.abinanti@ucsf.edu

415-353-9978

Study Officials

• Vanessa Jacoby, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 12, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 15, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-11

Locations

US (1)