Long-term placebo-controlled efficacy and safety study of Org OD 14 in climacteric women

Abstract

In a randomized, double-blind, placebo-controlled efficacy and safety study of Org OD 14 [(7 alpha,17 alpha)-17-hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one] in 60 post-menopausal women, the effects of treatment on clinical parameters (hot flushes and associated complaints) and laboratory parameters (routine haematology and biochemistry) were evaluated. Assessments were made before treatment and after 1, 3, 6, 9 and 12 mth of therapy (in the case of the laboratory parameters after 6 and 12 mth only). In total, 17 patients dropped out, 6 of whom were on Org OD 14 and 11 on placebo. Clinical parameters were evaluated by means of the Yates test. Org OD 14 had a significantly better effect than placebo on hot flushes and sweating at all stages of assessment. A similar effect, albeit to a lesser extent, was seen on sleeplessness, fatigability, irritability and psychic instability. Serum levels of alkaline phosphatase, triglycerides, high-density lipoprotein cholesterol and phosphate decreased during Org OD 14 treatment. It was concluded that Org OD 14 provides a new, efficient and safe means of treating the post-menopausal syndrome.