Clinical trial · Interventional
Pilot of Letrozole for Uterine Myomas
NCT02470741CI-TRIAL-00041670PLUMcompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Letrozole
- description
- Oral letrozole 2.5mg/day
- interventionNames
- Drug: Letrozole
- type
- PLACEBO_COMPARATOR
- label
- Placebo and Letrozole
- description
- Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months
- interventionNames
- Drug: Letrozole
- Other: Placebo
Primary outcomes (1)
- measure
- Changes in Fibroid-related Symptoms After Treatment With Letrozole
- timeFrame
- Baseline to 2 Months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.