THE EFFECTS OF A SPECIAL AGNUS-CASTUS EXTRACT (BP1095E1) ON PROLACTINSECRETION IN HEALTHY MALE-SUBJECTS

The effects of three doses of a special Agnus castus extract (BP1095E1 ) - extracts from 120 mg, 240 mg and 480 mg of drug per day - were exa mined within the framework of a placebo-controlled clinical study of t olerance and prolactin secretion in 20 healthy male subjects during a period of 14 days. There was good tolerance during the study as regard s the following: adverse effects, the effects on blood pressure and he art rate, blood count, Quick's test, clinical chemistry as well as tes tosterone, FSH and LH values. During each study phase the 24-hour prol actin secretion profile was measured from the penultimate to the final day, and the amount of prolactin release was monitored an hour after TRH stimulation on the last day. A significant increase in the 24-hour profile was registered with the lowest dose in comparison to placebo, the opposite being the case with the higher doses, i.e. a slight redu ction. In contrast to the administration of placebo, the 1-hour AUC af ter TRH stimulation resulted in a significant increase with the lowest dose and a significant reduction with the highest dose. The results s uggest effects of the special Agnus castus extract which are dependent on the dose administered and the initial level of prolactin concentra tion.