Abstracts

RATIONALE: Method variation in mice teratogenicity study (Bennett et al. 1996) indicated difficulty in achieving pregnancy during OCBZ administration. The present study was a test of this hypothesis in a pregnancy monkey model. METHODS: A total of N=14 female adult monkeys (Macaca fascicularis) were used in this study. Each was administered either one of three drugs (OCBZ, CBZ, synthetic CBZE) or water placebo by gastric catheter until pregnant or a maximum of 8 menses cycles whichever came first. A male (N=5 total) was allowed access to each female from day 9-18 following onset of menses. If a dam did not become pregnant in 8 menses cycles, she was randomly assigned to a different drug or to the placebo breeding condition. The 14 dams with multiple assignments comprised 11 OCBZ, 6 CBZ, 12 CBZE and 12 placebo breeding conditions during a 6-year period. Pregnancy rates were determined for each condition and compared by t-test statistic. RESULTS: The data revealed that dams on OCBZ took twice as long (>4 menses cycles) on average to become pregnant than dams while on other breeding conditions including placebo controls (?2 menses cycles; p<0.01) and that dams on CBZ or CBZE did not differ in pregnancy rate from one another or from placebo controls (p>0.49). There was no definitive evidence of early spontaneous abortions while on OCBZ. CONCLUSIONS: The mechanism(s) by which dams on OCBZ had difficulty in either achieving conception or a sustained pregnancy is currently unknown. Follow-up hormonal studies are indicated.