No abstract

The biological effects of a new synthetic progestagen, Org 2969 (13-ethyl \x=req-\ 11-methylene-18,19-dinor-17\g=a\-pregn-4-en-20-yn-17-ol) were studied in healthy normally menstruating women. Two of them were given 0.125 mg, five 0.060 mg and two 0.030 mg of Org 2969 daily on days 1\p=n-\20 during one menstrual cycle. Serum levels of follicle stimulating hormone, luteinizing hormone, progesterone and oestradiol were analyzed on days 8\p=n-\23 in order to evaluate the function of the hypophyseal-ovarian axis. The serum concentrations of aspartate amino transferase, alanine amino transferase, alkaline phosphatase, gamma glutamyl transpeptidase and bilirubin were determined to evaluate possible side effects on liver function on days 8, 15 and 23. Serum cortisol was measured on days 8 and 23. The basal body temperature was recorded daily during the whole cycle, and endometrium biopsies were taken on days 21 or 22 of the cycle. All samples were taken similarly during the treatment cycle and the preceding control cycle. According to the hormone determinations, all the treatment cycles were anovulatory except in one woman receiving the lowest dose. The treatment led to decreased spinnbarkeit, arborization and sperm penetration in the cervical mucus. Liver function tests and serum cortisol remained unchanged during the treatment.

No abstract

A low molecular weight heparinoid (Org 10172) was compared with unfractionated heparin in 36 patients on chronic hemodialysis in an open randomized cross-over study with three anti-coagulant treatment regimens for a single hemodialysis session. The anti-coagulant regimens were: a) standard heparin (3250–4750 I.U. heparin at start of hemodialysis followed by continuous infusion of 2000–2700 I.U. per hour); b) Org 10172 administered as a single intravenous bolus of 2400 anti-Xa units at start of dialysis; c) Org 10172 administered as a single bolus of 3200 anti-Xa units at start of dialysis. Plasma anti-Xa activity during hemodialysis was highest in regimen; d) and significantly lower when heparin was used. Mean β-thromboglobulin concentrations changed to the same extent in the three groups. Plasma platelet factor 4 concentrations were higher after the use of heparin. The extracorporeal circuit was maintained patent in all groups; the volume of blood retained in the dialyzers did not differ markedly. Org 10172 proved safe and its anticoagulant effect was sufficient at the dose levels studied.

The results of two open Finnish multicenter studies on the effects of two oral contraceptive combinations containing 0.150 mg desogestre1+0.030 mg ethinylestradiol (EE) and 0.150 mg desogestre1+0.020 mg EE respectively were comparatively evaluated, paying particular attention to efficacy, cycle control and tolerance. The two trials were carried out by 20 independent investigators and comprised a total of 270 women, 91 of whom used the0.150/0.030 mg desogestrel/EE combination for a total of 964 cycles in one trial and 179 the 0.150/0.020 mg desogestrel/EE combination for a total of 2096 cycles in the other trial. In addition the ovulation inhibiting effect of the combination with 0.020 mg EE (based on serum levels of LH, progesterone and 170-estradiol) was studied in 5 healthy fertile women. No pregnancies occurred in this study. Both combinations showed a good cycle control and were well tolerated. There were no marked differences between the two preparations with respect to bleeding patterns, body weight, side effects, or drug related drop-outs. The good efficacy of the lowest estrogen-dose combination was substantiated by the results of the hormone determinations: all 5 volunteers displayed an anovulatory treatment cycle. It is concluded that despite its lower estrogen content, the clinical use of the 0.150/0.020 mg desogestrel/EE combination is as good as that of the 0.150/0.030 mg desogestrel/EE combination.