Letrozole for Lymphangioleiomyomatosis

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT01353209
• Date of registration: 11/05/2011
• Prospective Registration: No
• Primary sponsor: University of Cincinnati
• Public title: Letrozole for Lymphangioleiomyomatosis TRAIL
• Scientific title: Trial of Letrozole in Lymphangioleiomyomatosis
• Date of first enrolment: May 2011
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01353209
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Francis X McCormack, MD
• Affiliation: University of Cincinnati

Key inclusion & exclusion criteria

Inclusion Criteria:

- Definite diagnosis of based on compatible chest CT and at least one of the following:

1. biopsy or cytology consistent with LAM, or

2. tuberous sclerosis, renal angiomyolipoma, cystic abdominal lymphangiomas, or
chylous effusion in the chest or abdomen, or

3. serum VEGF-D = 800 pg/uL.

- post bronchodilator FEV1 =80% predicted or DLCO =70% predicted or RV=120% predicted

- female and postmenopausal status as defined by one of the following:

1. prior bilateral oophorectomy or bilateral ovarian irradiation, or

2. age greater than 55 years, and no menstrual period for 12 months or longer.

3. age 18-55 years and estradiol level in the postmenopausal range in the absence of
current use of progestational agents.

- If still premenopausal, may enter if rendered medically postmenopausal on
clinical grounds with the use of gonadotropin releasing hormone (e.g.
leuprolide), as long as serum estradiol, FSH, and LH are in the
postmenopausal range

- Patients with osteopenia or osteoporosis must be receiving appropriate treatment for
their osteoporosis or osteopenia at entry into this study.

Exclusion Criteria:

- Known allergy to letrozole

- Inability to comply with pulmonary function tests or follow up visits.

- Treatment with investigational agents within 30 days

- Hormonal therapy (e.g. estrogen, progestin, LHRH agonists or antagonists, estrogen
receptor blockers, estrogen receptor down regulators, aromatase inhibitors) within 30
days month of registration

- Medical or psychiatric conditions that would interfere with the ability to provide
informed consent.

- abnormal hematologic and hepatic function as defined by the following at the time of
randomization.:

- Neutrophils < 1500/mm3 and platelets < 100,000/mm3

- Bilirubin < 1.25 X upper limit of normal

- SGPT (ALT) or SGOT (AST) >2.5 X upper limit of normal



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Lymphangioleiomyomatosis

Intervention(s)

Drug: Placebo

Drug: Letrozole

Primary Outcome(s)

Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month [Time Frame: 12 months]

Secondary Outcome(s)

Serum VEGF-D [Time Frame: twelve months]

Post-bronchodilator FVC [Time Frame: twelve months]

St George Respiratory Questionnaire [Time Frame: twelve months]

Secondary ID(s)

5708

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United States Department of Defense

Results

• Results available: Yes
• Date Posted: 17/04/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01353209