Mastodynon (R) for female infertility. Randomized, placebo-controlled clinical double-blind study

Objective and Design: The effects of Mastodynon(R), an Agnus castus-contain ing preparation, were investigated in 96 women with fertility disorders in a prospective, randomized, placebo-controlled, double-blind study. Patients and Methods: 38 women with secondary amenorrhoea, 31 women with luteal ins uffciency and 27 women with idiopathic infertility received 30 drops of Mas tadynon or placebo twice a day over a period of 3 months. Outcome Measure a nd Results: The outcome measure, which was pregnancy or spontaneous menstru ation in women with amenorrhoea and pregnancy or improved concentrations of luteal hormones in both other groups, was achieved in 31 out of 66 women w ho were suitable for evaluation. It was achieved more often in the Mastodyn on group compared to the placebo group (57.6% versus 36.0%, p=0.069). 15 wo men conceived during the observation period (n = 7 with amenorrhoea, n = 4 with idiopathic infertility, n = 4 with luteal insufficiency). In women wit h amenorrhoea or luteal insufficiency, pregnancy occurred in the Mastodynon group more than twice as often as in the placebo group. Under therapy no h ormonal changes were found at a 5% significance level. Only very few undesi rable drug effects were observed. Conclusion: In women with sterility due t o secondary amenorrhoea and luteal insufficiency, a treatment with Mastodyn on can be recommended over a period of 3 to 6 months.