RECRUITING

Prescription of Letrozole for Uterine Myoma

Conditions

Leiomyoma, Uterine Leiomyoma Fibroid Fibroid Uterus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.

Official Title

Letrozole for Treatment of Uterine Fibroids: A Randomized, Placebo-Controlled Trial

Quick Facts

Study Start:2024-07-24

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06143631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 53 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* At least 21 and less than 54 years of age (to focus on an adult, premenopausal population) * Female sex, based on sex identified on their birth certificate (no other gender requirements) * Have uterine leiomyomata that have been visualized on pelvic imaging (i.e., ultrasound or MRI) in the last 24 months * Report symptoms associated with leiomyomata such as heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, or dyspareunia for the past 3 months * Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of 30 or higher 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 * Agree to use a non-hormonal or barrier method of contraception with any sexual activity with a non-sterile male partner during the study period (i.e., use of copper IUD is consistent with eligibility)	* Screening pelvic imaging indicating any leiomyomata ≥10 cm in maximum diameter, or uterine size ≥16 cm in length (equivalent to 16 weeks gestation)-note that candidates who exclusively have prior clinical pelvic imaging 12-24 months ago will be excluded if imaging includes leiomyomata ≥9 cm in maximum diameter, or uterine size ≥15 cm in length, presuming leiomyoma growth of ≥1 cm per year * Screening pelvic imaging indicating only one, sole leiomyoma \<2 cm in maximum diameter * Any submucosal leiomyoma that is \>50% within uterine cavity (FIGO Type 0 or Type 1 leiomyomata) * Visit to the emergency room or hospitalization for leiomyoma symptoms in the last 12 weeks * Leiomyomata treated by surgery, radiologic procedure in the last 12 weeks; or plans to undergo any of the above in the next 24 weeks * Leiomyomata treated by GRNH agonist or antagonist in the last 12 weeks; or plans to use the above in the next 24 weeks * Currently pregnant or lactating, pregnant or lactating in the past 12 weeks, or planning to become pregnant in the next 24 weeks * Screening serum hemoglobin \<8 g/dL, or history of blood transfusion in the last 12 weeks (indicating severe anemia) * Screening cholesterol lipid panel testing showing LDL cholesterol level ≥ 190 mg/dL (due to rare side effects over long-term use of aromatase inhibitors in postmenopausal women) * Screening serum estradiol level \<30 pg/mL (consistent with postmenopausal status) * Irregularly timed bleeding, including bleeding or spotting in between periods, in the past 3 months. * History of osteoporosis (based on self-reported DEXA indicating bone mineral density Z-score \< -2.0 at spine, total hip, or femoral neck; a prior fracture judged to be a fragility fracture; or self-reported use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, or denosumab for bone density loss) * History of severe liver disease (Child Pugh Class C cirrhosis), posing safety risks for use of letrozole * Current or prior history of breast cancer (given potential need to take letrozole for breast cancer treatment or secondary prevention) * Screening pelvic imaging indicating an Ovarian-Adnexal Reporting and Data System (O-RADS) category 3, 4, or 5 ovarian or adnexal lesion * Screening pelvic imaging concerning for other current cancer of the gynecologic, genitourinary or gastrointestinal system * Prior hypersensitivity or significant adverse reaction to letrozole or any aromatase inhibitor, or to an ingredient in the placebo capsule * Use of letrozole, other aromatase inhibitor, or selective estrogen receptor modulator (SERM) medications in the past 4 weeks, or existing plans to initiate one of these in the next 24 weeks * Use of oral, vaginal, or topical exogenous estrogen, progestin, or androgen therapy in the past 4 weeks; or injectable forms of the above in the past 12 weeks; or plans to initiate any of the above in the next 24 weeks * Use of medications with potential unsafe interactions with letrozole in the past 4 weeks (methadone, levomethadone, nintedanib, thalidomide), or plans to initiate these in the next 24 weeks * Any condition that, in the opinion of the investigators, would interfere with ability to complete study procedures, including acute or uncontrolled mental health condition, substance abuse, or inability to complete procedures in English (or Spanish, for sites that offer study assessments in Spanish)

Inclusion Criteria

Exclusion Criteria

* At least 21 and less than 54 years of age (to focus on an adult, premenopausal population)
* Female sex, based on sex identified on their birth certificate (no other gender requirements)
* Have uterine leiomyomata that have been visualized on pelvic imaging (i.e., ultrasound or MRI) in the last 24 months
* Report symptoms associated with leiomyomata such as heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, or dyspareunia for the past 3 months
* Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of 30 or higher 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
* Agree to use a non-hormonal or barrier method of contraception with any sexual activity with a non-sterile male partner during the study period (i.e., use of copper IUD is consistent with eligibility)

* Screening pelvic imaging indicating any leiomyomata ≥10 cm in maximum diameter, or uterine size ≥16 cm in length (equivalent to 16 weeks gestation)-note that candidates who exclusively have prior clinical pelvic imaging 12-24 months ago will be excluded if imaging includes leiomyomata ≥9 cm in maximum diameter, or uterine size ≥15 cm in length, presuming leiomyoma growth of ≥1 cm per year
* Screening pelvic imaging indicating only one, sole leiomyoma \<2 cm in maximum diameter
* Any submucosal leiomyoma that is \>50% within uterine cavity (FIGO Type 0 or Type 1 leiomyomata)
* Visit to the emergency room or hospitalization for leiomyoma symptoms in the last 12 weeks
* Leiomyomata treated by surgery, radiologic procedure in the last 12 weeks; or plans to undergo any of the above in the next 24 weeks
* Leiomyomata treated by GRNH agonist or antagonist in the last 12 weeks; or plans to use the above in the next 24 weeks
* Currently pregnant or lactating, pregnant or lactating in the past 12 weeks, or planning to become pregnant in the next 24 weeks
* Screening serum hemoglobin \<8 g/dL, or history of blood transfusion in the last 12 weeks (indicating severe anemia)
* Screening cholesterol lipid panel testing showing LDL cholesterol level ≥ 190 mg/dL (due to rare side effects over long-term use of aromatase inhibitors in postmenopausal women)
* Screening serum estradiol level \<30 pg/mL (consistent with postmenopausal status)
* Irregularly timed bleeding, including bleeding or spotting in between periods, in the past 3 months.
* History of osteoporosis (based on self-reported DEXA indicating bone mineral density Z-score \< -2.0 at spine, total hip, or femoral neck; a prior fracture judged to be a fragility fracture; or self-reported use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, or denosumab for bone density loss)
* History of severe liver disease (Child Pugh Class C cirrhosis), posing safety risks for use of letrozole
* Current or prior history of breast cancer (given potential need to take letrozole for breast cancer treatment or secondary prevention)
* Screening pelvic imaging indicating an Ovarian-Adnexal Reporting and Data System (O-RADS) category 3, 4, or 5 ovarian or adnexal lesion
* Screening pelvic imaging concerning for other current cancer of the gynecologic, genitourinary or gastrointestinal system
* Prior hypersensitivity or significant adverse reaction to letrozole or any aromatase inhibitor, or to an ingredient in the placebo capsule
* Use of letrozole, other aromatase inhibitor, or selective estrogen receptor modulator (SERM) medications in the past 4 weeks, or existing plans to initiate one of these in the next 24 weeks
* Use of oral, vaginal, or topical exogenous estrogen, progestin, or androgen therapy in the past 4 weeks; or injectable forms of the above in the past 12 weeks; or plans to initiate any of the above in the next 24 weeks
* Use of medications with potential unsafe interactions with letrozole in the past 4 weeks (methadone, levomethadone, nintedanib, thalidomide), or plans to initiate these in the next 24 weeks
* Any condition that, in the opinion of the investigators, would interfere with ability to complete study procedures, including acute or uncontrolled mental health condition, substance abuse, or inability to complete procedures in English (or Spanish, for sites that offer study assessments in Spanish)

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

(510) 788-0545

plumstudy@ucsf.edu

Lisa Abinanti

CONTACT

lisa.abinanti@ucsf.edu

Principal Investigator

Vanessa Jacoby, MD, MAS

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Alison Huang, MD, MAS

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94115

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Vanessa Jacoby, MD, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Alison Huang, MD, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-24

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-07-24

Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

Leiomyoma, Uterine
Leiomyoma
Fibroid
Fibroid Uterus