Double-blind, placebo-controlled psychometric studies on the effects of a combined estrogen-progestin regimen versus estrogen alone on performance, mood and personality of menopausal syndrome patients

The influence of a combined estrogenprogestin regimen (Climodien (R)) on no opsyche, thymopsyche, personality and psychophysiological measures of menop ausal syndrome patients was investigated in a double-blind, placebo-control led, comparative, randomized 3-arm trial phase (Climodien 2/3 = estradiol v alerate (CAS 979-32-8) 2 mg + the progestin dienogest (CAS 65928-58-7) 3 mg = regimen A, estradiol valerate 2 mg = regimen EV, and placebo = regimen P ) followed by an open-label phase in which all patients received Climodien 2/2 (estradiol valerate 2 mg + dienogest 2 mg) = regimen A*. 49 women (16, 17, 16 valid patients per arm) aged between 46 and 67 years (mean 58, 58, 5 6 years, respectively)with the diagnoses of insomnia (G 47.0) related to po stmenopausal syndrome (N 95.1) were included in the analysis of the double- blind phase. Both the double-blind and the open-label phase lasted 2 months . Noopsychic investigations demonstrated an improvement in associative verbal memory after 2 months of regimen A, which was significant as compared with both baseline and placebo. Regarding visual memory, regimen A* induced an improvement, which was significantly different from the decline in correct reproductions in the Benton Test observed under estradiol. Errors in the Be nton Test decreased significantly after regimen A* as compared with regimen EV. These findings suggest that hormone replacement therapy with estradiol , and even more in combination with dienogest, improves verbal and visual m emory, which is in line with the improvement in information processing spee d and capacity objectified by event-related potentials (ERP). Thymopsychic investigations demonstrated a significant improvement in somat ic complaints and trait anxiety after both regimen A and regimen EV as comp ared with baseline. State anxiety decreased significantly under regimen A* as compared with EV. The Freiburger Personality inventory showed an improve ment in aggressivity after regimen A* as compared with the preceding placeb o as well as an improvement in striving after dominancy after both regimen A and regimen EV as compared with pre-treatment, but also after regimen A* as compared with regimen EV; Extraversion increased after 2 months of regim en A as compared to, regimen P. Psychophysiological findings including pupi llary and skin conductance Variables were not significant.