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New treatment option for Leiomyoma, Uterine
Official title Prescription of Letrozole for Uterine Myoma
ClinicalTrials.gov ID: NCT06143631
What this study is testing
What is Letrozole 2.5mg?
Letrozole 2.5mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for leiomyoma, uterine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 53, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of 30 or higher at baseline
You likely can't join if
- Screening pelvic imaging indicating any leiomyomata ≥10 cm in maximum diameter, or uterine size ≥16 cm in length (equivalent to 16 weeks...
- 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 (if injected) or in the last 4 weeks (if oral); or plans to use the above in...
See the full eligibility 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 had a menstrual period in the past 3 months (90 days)
- 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...
- 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 (if injected) or in the last 4 weeks (if oral); 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)
- For women aged 45 years or older only: irregular menstrual cycles (menstrual cycles \ 38 days between periods), prolonged menstrual bleeding (bleeding \>14 days), or bleeding in between menstrual periods, unless already...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Rochester, Minnesota, United States
- Jackson, Mississippi, United States
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 53 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Rochester, Minnesota, United States; Jackson, Mississippi, United States; Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.