Bioequivalency comparison between two gonadotropin-releasing hormone products

The bioequivalency of 2 gonadotropin-releasing hormone (GnRH) preparations, gonadorelin diacetate tetrahydrate and gonadorelin semicarbonate, was compared on the basis of luteinizing hormone (LH)-releasing ability of the 2 products in diestrous dairy cows. Twenty-four cycling, nonlactating Holstein cows were subjected to a double prostaglandin estrus synchronization treatment to simultaneously control stage of the estrous cycle and time factors as potential variables effecting LH responses to the treatments being studied. Circulating progesterone concentration was determined to verify stage of cycle at strategic times throughout the study. Twelve days after the second prostaglandin treatment, all cows were randomly assigned to 1 of 2 groups (n = 12). Each group of 12 cows received single doses (100 μg) of either GnRH preparation at the start of each test period in a 2-period crossover design. Serum samples were obtained prior to and at 12 times (10, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, and 1,440 minutes) after treatment and were assayed to determine circulating LH concentration. Significant difference between the 2 GnRH products was not found with respect to: mean concentration of LH in the blood during the 24 hours after treatment; maximal LH concentration; time from treatment to maximal LH concentration; and area under the LH concentration curve from time 0 through each of 7 times after treatment (0.5, 1, 1.5, 2, 4, 8, and 24 hours). These data confirm the bioequivalency of the 2 GnRH products.