Zonagen Presents Results From Study of Progenta for Uterine Fibroids

Zonagen has reported results after three months of dosing from its study of Progenta in the treatment of uterine fibroids.

The study included three dose levels of Progenta as well as placebo and positive control arms. The positive control was Lucrin, an approved gonadotropin releasing agonist (GnRHa), commonly used for the treatment of fibroids. Progenta was administered as a daily oral dose of 12.5-, 25- or 50-mg capsules.

After three months of exposure the mean change in fibroid cross sectional area, reported as a percent of time zero area, was 95 percent for placebo, 83.8 percent for 12.5 mg Progenta, 64.9 percent for 25 mg Progenta, 59.1 percent for 50 mg Progenta and 62.5 percent for Lucrin. Both the 25- and 50-mg Progenta doses, as well as Lucrin, achieved a statistically significant reduction in mean fibroid size after three months compared to time zero.

The drug was well-tolerated at all doses, with headaches being the most common adverse event to be reported over the course of the study. The incidence of headaches across all groups was three, zero, five, five and 15 events for placebo, 12.5 mg, 25 mg, 50 mg and Lucrin, respectively.

The study initially enrolled 30 women diagnosed with uterine fibroids, and 28 women actually completed the study. One woman was discontinued due to the finding of a uterine tumor on the initiation visit and the other was dropped due to her inability to adhere to the clinical visitation schedule. Six women were randomized into each group. The early discontinuations occurred in the 50-mg Progenta and Lucrin groups.

Although the women in both the mid and high dose Progenta groups had fibroid reduction, as measured by ultrasound, numerically equivalent to or superior to the GnRHa, it should be cautioned that this was a small study.