Health TrialsbyHealthPanel

Prescription of Letrozole for Uterine Myoma

ConditionsLeiomyoma, UterineLeiomyomaFibroidFibroid Uterus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age21-53
SponsorUniversity of California, San Francisco

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Letrozole 2.5mg

    Drug

    Oral letrozole 2.5mg/day

  • Placebo

    Other intervention

    Placebo capsule

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: LetrozoleExperimental treatment 1 intervention
Group B: Placebo and LetrozolePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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 \[Range 8-40 with higher score indicating worse symptoms and worse outcomes\]

Time frame
Baseline to 12 weeks

Secondary outcomes

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 \[Range 29-145 points, with higher score indicating better QoL and better outcomes\]

Time frame
Baseline to 12 weeks
2

Total leiomyoma volume over 12 weeks of treatment

Change in total leiomyoma volume based on pelvic ultrasound measurements

Time frame
Baseline to 12 weeks
3

Total uterine volume over 12 weeks of treatment

Change in total uterine volume based on pelvic ultrasound measurements

Time frame
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 \[Range 0-48 with higher MBQ score indicating worse symptoms and a negative impact on quality of life\]

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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