Use of Org OD 14 for the treatment of climacteric complaints.
The effects of treating climacteric complaints in post-menopausal women were studied in an open trial in which Org OD 14, a placebo and no treatment were compared. In addition to the symptomatic effects, clinical and laboratory parameters were also studied. One hundred and twenty-four women who had undergone a natural or surgical menopause completed 4 mth of randomized treatment; 35 received Org OD 14 (2.5 mg/day, per os), 46 a placebo, and 43 no treatment. The mean ages and time in years since menopause were comparable for each group. The parameters were assessed before treatment and after 4 mth. The results in the group treated with Org OD 14 were compared statistically with those for the other two groups using the chi 2 test, Student's t test or analysis of variance. A beneficial effect on clinical parameters was seen following Org OD 14 treatment. The results as regards hot flushes and sweating were significantly better statistically than those in the other groups. Org OD 14 was found to have no effect on the endometrium, breasts, body weight or blood pressure, while vaginal atrophy was slightly improved. Serum levels of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides and phosphate were slightly reduced by Org OD 14. Liver function tests, clotting factors and the other routine laboratory parameters were not affected by Org OD 14 treatment. It was concluded that Org OD 14 is an effective and safe compound for the treatment of climacteric syndrome.
De Aloysio
D
D
Fabiani
A G
AG
Mauloni
M
M
Bottiglioni
F
F
D002118:Calcium / Q000378:metabolism; D002979:Climacteric / Q000187:drug effects*; D002986:Clinical Trials as Topic; D004717:Endometrium / Q000187:drug effects; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D009652:Norpregnenes / Q000009:adverse effects / Q000627:therapeutic use*; D010710:Phosphates / Q000097:blood; D011897:Random Allocation; D008083:beta-Lipotropin / Q000097:blood
D008055:Lipids; D009652:Norpregnenes; D010710:Phosphates; D008083:beta-Lipotropin; C027385:tibolone; D002118:Calcium