Pilot of Letrozole for Uterine Myomas

NCT ID: NCT02470741

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Letrozole

Oral letrozole 2.5mg/day

Group Type: EXPERIMENTAL

Letrozole

Intervention Type: DRUG

Placebo and Letrozole

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

Group Type: PLACEBO_COMPARATOR

Letrozole

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Interventions

Letrozole

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Femara

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Jacoby, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.ucsf.edu/fibroids

Fibroid Trials at UCSF

Other Identifiers

15-15678

Identifier Type: -

Identifier Source: org_study_id