Trial · NCT01353209
Letrozole for Lymphangioleiomyomatosis
NCT01353209, Phase 2, Completed, University of Cincinnati; results first posted 2024-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Letrozole for Lymphangioleiomyomatosis. Trials, record NCT01353209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01353209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Letrozole for Lymphangioleiomyomatosis
- NCT number
- NCT01353209
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Cincinnati
- Conditions
- Lymphangioleiomyomatosis
- Interventions
- Letrozole, Placebo
- First posted
- 2011-05-12
- Last updated
- 2024-04-17
- Results first posted
- 2024-04-17
- Limitations and caveats
Under enrollment. Post menopause not originally assessed by estradiol levels. Small sample sizes led to some imbalances in baseline parameters, such as VEGF-D levels and bronchodilator responsiveness, which could have biased outcomes.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month | 12 months | FEV1 values reported are in liters or milliliters. There are no definite minimum and maximum values of FEV1 as it is a physiological measure of lung function and varies from individual to individual. Higher FEV1 scores indicate better lung function. |
| Secondary | Post-bronchodilator FVC | twelve months | Post-bronchodilator FVC in milliliters |
| Secondary | St George Respiratory Questionnaire | twelve months | Quality of Life scale for respiratory symptoms. This is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating worse quality of life. |
| Secondary | Serum VEGF-D | twelve months | VEGF-D values represent serum VEGF-D levels in pg/ml. Higher levels of VEGF-D are associated with Lymphangioleiomyomatosis. A serum VEGF-D greater than 400 pg/ml is a diagnostic biomarker for LAM. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month | 12 months | milliliters per month | MEDIAN | |
| SECONDARY | Post-bronchodilator FVC | twelve months | milliliters per month | MEDIAN | |
| SECONDARY | St George Respiratory Questionnaire | twelve months | score on a scale | MEDIAN | |
| SECONDARY | Serum VEGF-D | twelve months | pg/ml | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month | Letrozole | 1.04 | 95% Confidence Interval 0.56 to 2.02 | milliliters per month | |
| Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month | Placebo | 1.66 | 95% Confidence Interval 0.77 to 2.63 | milliliters per month | |
| Post-bronchodilator FVC | Letrozole | 2.58 | Full Range 2.07 to 3.44 | milliliters per month | |
| Post-bronchodilator FVC | Placebo | 2.46 | Full Range 1.26 to 3.21 | milliliters per month | |
| St George Respiratory Questionnaire | Letrozole | 38 | Full Range 27 to 53 | score on a scale | |
| St George Respiratory Questionnaire | Placebo | 62 | Full Range 38 to 82 | score on a scale | |
| Serum VEGF-D | Letrozole | 572 | Full Range 294 to 1816 | pg/ml | |
| Serum VEGF-D | Placebo | 944 | Full Range 350 to 1598 | pg/ml |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Letrozole | 9 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Letrozole | 8 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Letrozole | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Swollen lymph nodes | Blood and lymphatic system disorders | Letrozole | 1 | 9 | 1 |
| other | Swollen lymph nodes | Blood and lymphatic system disorders | Placebo | 1 | 8 | 1 |
| other | Chest pain | Cardiac disorders | Letrozole | 0 | 9 | 0 |
| other | Chest pain | Cardiac disorders | Placebo | 1 | 8 | 1 |
| other | Endocrine disorder | Endocrine disorders | Letrozole | 1 | 9 | 1 |
| other | Endocrine disorder | Endocrine disorders | Placebo | 0 | 8 | 0 |
| other | Blurry vision | Eye disorders | Letrozole | 1 | 9 | 1 |
| other | Blurry vision | Eye disorders | Placebo | 1 | 8 | 1 |
| other | abdominal pain; nausea | Gastrointestinal disorders | Letrozole | 1 | 9 | 4 |
| other | abdominal pain; nausea | Gastrointestinal disorders | Placebo | 1 | 8 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Letrozole | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Letrozole | 1 | 9 |
| Total, other adverse events | Placebo | 1 | 8 |
| Total, serious adverse events | Letrozole | 0 | 9 |
| Total, serious adverse events | Placebo | 1 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28570161 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Letrozole vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01353209
GET https://conductscience.org/api/trials/v1/NCT01353209/registered