CompletedPhase 2

Letrozole for Lymphangioleiomyomatosis

United States17 participantsStarted 2011-05

Plain-language summary

The hypothesis in this study is that estrogen suppression by an aromatase inhibitor in postmenopausal women with lymphangioleiomyomatosis (LAM) will prevent or delay progression of lung disease and result in a decrease in the rate of decline in FEV1

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. biopsy or cytology consistent with LAM, or
✓. tuberous sclerosis, renal angiomyolipoma, cystic abdominal lymphangiomas, or chylous effusion in the chest or abdomen, or
✓. serum VEGF-D ≥ 800 pg/uL.
✓. prior bilateral oophorectomy or bilateral ovarian irradiation, or
✓. age greater than 55 years, and no menstrual period for 12 months or longer.
✓. age 18-55 years and estradiol level in the postmenopausal range in the absence of current use of progestational agents.

What they're measuring

Rate of Change in Forced Expiratory Volume in 1 Second in ml/Month

Timeframe: 12 months

Trial details

NCT IDNCT01353209

SponsorUniversity of Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2023-10-11

View on ClinicalTrials.gov More Lymphangioleiomyomatosis trials