Puerperal Lactation Inhibition with a Novel 8α-Aminoergoline (CU 32-085)

Abstract

The clinical efficacy of CU 32-085, a novel ergoline derivative, in puerperal lactation inhibition was investigated in 41 healthy postpartum women and compared with serum concentrations of prolaction (PRL) and CU 32-085. The women received 0.5 mg CU 32-085 twice daily for 14 days. In 40 women (i.e. 97%) treatment with CU 32-085 successfully inhibited lactation; slight to moderate breast activity appearing during the first few days receded spontaneously. 1 woman experienced full milk let-down on day 5 of treatment. No rebound lactational phenomena were recorded. 5 h after the initial dose, mean serum PRL concentrations decreased by 82% (from 169 to 30 ng/ml), and PRL values remained at that level during the course of treatment. The mean serum concentrations of CU 32-085 showed an inverse pattern compared to PRL. CU 32-085 was well tolerated, with transient slight to moderate dizziness, headache and nausea reported by 12 women (29%) following the initial dose. These disappeared after an average of 3 h. Routine safety chemistries remained within the normal range, and no statistically significant differences between the treatment group and the control group (25 normal nursing postpartum women) were encountered. It is concluded that CU 32-085, a potent dopamine agonist, is an effective and well-tolerated treatment in the indication of postpartum lactation inhibition.