Pilot of Letrozole for Uterine Myomas

Uterine Fibroids Clinical Trial

— PLUM  

Official title:

Pilot of Letrozole for Uterine Myomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470741
• Other study ID #: 15-15678
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. =21 years old

2. Premenopausal (at least one menses in last 3 months)

3. Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)

4. 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

5. 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)

6. Up to date in Pap smear screening and surveillance

7. Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells

8. Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy

9. Has primary care provider or gynecologist

10. Agrees not to start new medications/treatments for fibroids during the study

11. Able to give informed consent

Exclusion Criteria:

1. Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months

2. Any submucosal fibroid =2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection

3. Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months)

4. Pregnant, lactating, or planning to become pregnant in the next 6 months

5. Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo)

6. History of osteopenia or osteoporosis

7. History of hyperlipidemia

8. Current liver or kidney disease

9. Unable or unwilling to attend 4 study visits

10. Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system

11. Does not have primary care provider or gynecologist

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Letrozole

Other:
• Placebo

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Fibroid Trials at UCSF