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Leiomyoma, UterinePhase 4PLUMNCT06143631

Prescription of Letrozole for Uterine Myoma

A Phase 4 study testing Letrozole 2.5mg in people with Leiomyoma, Uterine and Leiomyoma, run by University of California, San Francisco at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 53 years, women onlyHealthy volunteers can take part
Conditions the study is for
Leiomyoma, Uterine, Leiomyoma, Fibroid
What is being tested?
Letrozole 2.5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
5 sitesUnited States
Study dates
24 Jul 2024to 11 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 53 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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 (if injected) or in the last 4 weeks (if oral); or plans to use the above in the next 24 weeks
Show all 21Show fewer
  • 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 <21 days or >38 days between periods), prolonged menstrual bleeding (bleeding >14 days), or bleeding in between menstrual periods, unless already evaluated by a clinician to discuss endometrial biopsy (uterine biopsy) to rule out endometrial hyperplasia.
  • 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)

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

(510) 788-0545

plumstudy@ucsf.edu

Lisa Abinanti contact

lisa.abinanti@ucsf.edu

5 sites in 1 country

United States5 sites, 5 recruiting

  • Duke University

    Durham, North Carolina, 27710

    Study Coordinator, 919-572-7927, fertilityresearch@duke.edu

    Craig Sobolewski, MD

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Study Coordinator, 601-984-6628, lmelaku@umc.edu

    Sheila Belk

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Study Coordinator, 310-794-3467, sfkhan@mednet.ucla.edu

    Ram Parvataneni, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Clinical Research Coordinator, 507-422-3984, Wroblewski.stacy@mayo.edu

    Sarah Rassier, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94115

    Maria Tolentino, plumstudy@ucsf.edu

    Yulissa Oceguera-Barragan, plumstudy@ucsf.edu

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Letrozole 2.5mg, Placebo
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Letrozole 2.5mgDrug

    Oral letrozole 2.5mg/day

  • PlaceboOther

    Placebo capsule

Study groups in NCT06143631
Study groupRoleWhat they receive
LetrozoleExperimentalOral letrozole 2.5mg/day
Receives: Drug: Letrozole 2.5mg
Placebo and LetrozolePlacebo comparatorPlacebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks
Receives: Drug: Letrozole 2.5mg; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uterine leiomyoma-related symptom severity over 12 weeks of treatment

    Change in Uterine Fibroid Symptoms Quality of Life (UFS-QOL) Symptom Severity Scale (SSS) score [Range 8-40 with higher score indicating worse symptoms and worse outcomes]

    Measured: Baseline to 12 weeks

Secondary outcomes (10)

  1. Uterine leiomyoma-related quality of life over 12 weeks of treatment

    Change in Uterine Fibroid Symptoms Quality of Life (UFS-QOL) Health-Related QOL component score [Range 29-145 points, with higher score indicating better QoL and better outcomes]

    Measured: Baseline to 12 weeks

  2. Total leiomyoma volume over 12 weeks of treatment

    Change in total leiomyoma volume based on pelvic ultrasound measurements

    Measured: Baseline to 12 weeks

  3. Total uterine volume over 12 weeks of treatment

    Change in total uterine volume based on pelvic ultrasound measurements

    Measured: Baseline to 12 weeks

  4. Symptoms of heavy menstrual bleeding

    Change in symptoms of heavy menstrual bleeding based on a modified Menstrual Bleeding Questionnaire (MBQ) score [Range 0-48 with higher MBQ score indicating worse symptoms and a negative impact on quality of life]

    Measured: Baseline to 12 weeks

  5. Improvement in Sexual Functioning

    Change in pelvic problems-related sexual function as measured by the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) Pelvic Problems Interference subscale score [Range 0-100 with higher scores indicating better sexual function]

    Measured: Baseline to 12 weeks

  6. Symptoms of pelvic pain

    Change in pelvic pain severity/intensity "on average" (evaluated on a standard numerical rating scale of 0-10, lower rating indicating better outcomes and less pain)

    Measured: Baseline to 12 weeks

  7. Symptoms of urogenital distress

    Change in distressing urogenital symptoms such as urinary frequency, urinary incontinence, and genital pain, as measured by Urogenital Distress Inventory-6 (UDI-6) [Range 0-100 with higher scores indicating higher disability/worse outcomes]

    Measured: Baseline to 12 weeks

  8. Effect of letrozole on serum cholesterol levels

    Change in serum LDL cholesterol levels

    Measured: Baseline to 12 weeks

  9. Effect of letrozole on serum estradiol levels

    Change in serum estradiol levels

    Measured: Baseline to 12 weeks

  10. Effect of letrozole on frequency of hot flashes

    Change in frequency of vasomotor symptoms (hot flashes) as measured by the Hot Flush Rating Scale (HFRS) [no scale range but less # of reported hot flashes indicates better outcome]

    Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start24 Jul 2024
  3. Primary completion11 Sep 2028 (estimated)
  4. Study completion11 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06143631
Sponsor's protocol ID
23-39255
Other IDs
R01HD112465
Acronym
PLUM
Status last verified
Oct 2026
First submitted
15 Nov 2023
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Letrozole 2.5mg in people with Leiomyoma, Uterine and Leiomyoma, run by University of California, San Francisco at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Coordinator ((510) 788-0545, plumstudy@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uterine leiomyoma-related symptom severity over 12 weeks of treatment (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06143631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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