LeiomyomaPhase 4PLUMNCT02470741
Pilot of Letrozole for Uterine Myomas
A Phase 4 study testing Letrozole in people with Leiomyoma and Uterine Fibroids, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Leiomyoma, Uterine Fibroids
- What is being tested?
- Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥21 years old
- Premenopausal (at least one menses in last 3 months)
- Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)
- 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
- 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)
- Up to date in Pap smear screening and surveillance
Show all 11Show fewer
- Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells
- Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy
- Has primary care provider or gynecologist
- Agrees not to start new medications/treatments for fibroids during the study
- Able to give informed consent
Who cannot join
- Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months
- Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection
- Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months)
- Pregnant, lactating, or planning to become pregnant in the next 6 months
- Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo)
- History of osteopenia or osteoporosis
Show all 11Show fewer
- History of hyperlipidemia
- Current liver or kidney disease
- Unable or unwilling to attend 4 study visits
- Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system
- Does not have primary care provider or gynecologist
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
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
- Leiomyoma, Uterine Fibroids
- Being tested
- Letrozole, Placebo
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Oral letrozole 2.5mg/day Receives: Drug: Letrozole |
| Placebo and Letrozole | Placebo comparator | Intermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months Receives: Drug: Letrozole; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fibroid-related Symptoms After Treatment With Letrozole
The Uterine Fibroid Sympton and Quality of Life (UFS-QoL) Symptom Severity score measures self-reported severity of fibroid-related symptoms. Symptoms include: fatigue, sleep, self-image, mood disturbances/psychologic distress, fear of embarrassment, interference with daily activities, relationships with family and friends, and sexual functioning.
Scores range from 0 to 100; higher scores indicate greater symptom severity.
Measured: Baseline to 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Jacoby, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470741
- Sponsor's protocol ID
- 15-15678
- Acronym
- PLUM
- Status last verified
- Nov 2019
- First submitted
- 4 Jun 2015
- Last updated
- 15 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Letrozole for Uterine Myomas
- ClinicalTrials.gov ID
- NCT02470741
- Acronym / sponsor ID
- PLUM / 15-15678
- Conditions
- Leiomyoma, Uterine Fibroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: LetrozoleOral letrozole 2.5mg/day |
| Placebo and Letrozole | Placebo comparator | Drug: Letrozole, Other: PlaceboIntermittent oral letrozole 2.5mg/day for 2 months and an identical placebo capsule for 4 months |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥21 years old
- Premenopausal (at least one menses in last 3 months)
- Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia)
- 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
- 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)
Key exclusion criteria (11 listed)
- Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months
- Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection
- Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months)
- Pregnant, lactating, or planning to become pregnant in the next 6 months
- Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleAlso: Femara | Drug | Letrozole, Placebo and Letrozole |
| Placebo | Other | Placebo and Letrozole |
Primary outcome
Changes in Fibroid-related Symptoms After Treatment With Letrozole
Time frame: Baseline to 2 Months
The Uterine Fibroid Sympton and Quality of Life (UFS-QoL) Symptom Severity score measures self-reported severity of fibroid-related symptoms. Symptoms include: fatigue, sleep, self-image, mood disturbances/psychologic distress, fear of embarrassment, interference with daily activities, relationships with family and friends, and sexual functioning. Scores range from 0 to 100; higher scores indicate greater symptom severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Fibroid Trials at UCSFLink provided by the sponsor.
Related trials for Leiomyoma
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Jacoby, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole in people with Leiomyoma and Uterine Fibroids, run by University of California, San Francisco at 1 site 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 11 inclusion and 11 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: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fibroid-related Symptoms After Treatment With Letrozole (time frame: Baseline to 2 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2019.