Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
140 participants
INTERVENTIONAL
2024-07-24
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Letrozole
Oral letrozole 2.5mg/day
Letrozole 2.5mg
Oral letrozole 2.5mg/day
Placebo and Letrozole
Placebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks
Letrozole 2.5mg
Oral letrozole 2.5mg/day
Placebo
Placebo capsule
Interventions
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Letrozole 2.5mg
Oral letrozole 2.5mg/day
Placebo
Placebo capsule
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
21 Years
53 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Vanessa Jacoby, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Alison Huang, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Duke University
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Maria Tolentino
Role: primary
Yulissa Oceguera-Barragan
Role: backup
Clinical Research Coordinator
Role: primary
Study Coordinator
Role: primary
Sheila Belk
Role: backup
Study Coordinator
Role: primary
Other Identifiers
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23-39255
Identifier Type: -
Identifier Source: org_study_id