Adverse gynecologic events halt research on promising SERM. (Cautionary Tale).

BERLIN -- A selective estrogen-receptor modulator that looked very promising in phase II studies was shelved just 3 months into a phase III international trial when it became clear that subjects were suffering serious gynecologic consequences, serving as a potential warning about other SERMS in development.

Dr. Lise Warming, a researcher who studied the SERM for the Center for Clinical and Basic Research in Ballerup, Denmark, called the levormeloxifene story "disturbing."

Developed by Novo Nordisk A/S of Denmark, levormeloxifene was determined in early studies to have an estrogen-like effect on bone and lipids, while sparing the breast and endometrium. "It was one of the many potentially useful SERMs designed to prevent osteoporosis," Dr. Warming said at the 10th World Congress on the Menopause.

Phase II trials enrolled 250 healthy postmenopausal women aged 45-65 in the United States, Europe, and Japan. They were randomly assigned to take 1.25 mg, 5 mg, 10 mg, or 20 mg of levormeloxifene each day for a year or placebo. Transvaginal ...