A double-blind cross-over study on the effects of ORG OD14 compared to oestradiol valerate and placebo on lipid and carbohydrate metabolism in oophorectomized women

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Abstract
ORG OD14 [tibolone] is a synthetic steroid which in traditional bioassays has estrogenic and progestogenic and very weak androgenic-anabolic properties. As judged from earlier studies, this steroid seems suitable for continuous treatment of climacteric deficiency symptoms. An attempt was made to evaluate the effects induced by OD14 on lipid, lipoprotein and carbohydrate metabolism, as compared to E2V [estradiol valerate] and placebo. Twenty-two women, oophorectomized as part of the treatment of cervical carcinoma in clinical stage IB or IIA, were given ORG OD14 2.5 mg/day, E2V 2 mg/day and a placebo for 6 wk each, in a double-blind cross-over study. There was a marked decrease in all lipid components of HDL (high density lipoprotein), i.e., total and free cholesterol, triglycerides and phospholipids (P < 0.01), after OD14. The oral glucose tolerance test showed higher values after OD14 compared to both E2V and placebo (P < 0.05), indicating a slightly impaired glucose tolerance. The lipid metabolic changes induced by OD14 indicate a rather strong androgenic influence in this respect.