Prescription of Letrozole for Uterine Myoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, San Francisco
Study ID
NCT06143631
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Fibroid
  • Fibroid Uterus
  • Leiomyoma
  • Leiomyoma, Uterine

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 53 Years
Healthy Volunteers
Accepted

Interventions

  • Letrozole 2.5mg — DRUG
    Oral letrozole 2.5mg/day
  • Placebo — OTHER
    Placebo capsule

Study Details

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.

Key Dates

Start date
Jul 24, 2024
Status verified
Jun 2026
Primary completion
Sep 6, 2027
Completion
Dec 13, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Letrozole
    Oral letrozole 2.5mg/day
  • Placebo Comparator: Placebo and Letrozole
    Placebo capsule for 12 weeks; Oral letrozole 2.5mg/day for 12 weeks

Primary Outcome Measure

Uterine leiomyoma-related symptom severity over 12 weeks of treatment [ Time Frame: Baseline to 12 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Study Coordinator
[email protected]
310-794-3467
Ram Parvataneni, MD (PRINCIPAL_INVESTIGATOR)
Jacqueline Fahey, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94115
Maria Tolentino
[email protected]
Yulissa Oceguera-Barragan
[email protected]
Vanessa L Jacoby, MD, MAS (PRINCIPAL_INVESTIGATOR)
Alison Huang, MD, MAS (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Clinical Research Coordinator
[email protected]
507-422-3984
Sarah Rassier, MD (PRINCIPAL_INVESTIGATOR)
University of Mississippi Medical CenterJacksonMississippi39216
Study Coordinator
[email protected]
601-984-6628
Sheila Belk
Kedra Wallace, PhD (PRINCIPAL_INVESTIGATOR)
Elizabeth Lutz, MD (SUB_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Study Coordinator
[email protected]
919-681-0308
Craig Sobolewski, MD (PRINCIPAL_INVESTIGATOR)

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