摘要:

The results of two open Finnish multicenter studies on the effects of two oral contraceptive combinations containing 0.150 mg desogestrel+0.030 mg ethinylestradiol (EE) and 0.150 mg desogestrel+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 the 0.150/0.030 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 17β‐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 combi

ISSN:0001-6349    

DOI:10.3109/00016348709156488

出版商:Blackwell Publishing Ltd    

年代:1987

数据来源: WILEY

摘要:

Abstract.The efficacy and cycle control of and tolerance to a new oral contraceptive combination containing 0.150 mg desogestrel + 0.020 mg ethinylestradiol was investigated by seven Belgian investigators in a total of 295 women (7257 cycles). The trial was set up as a part of a larger European open multi‐center study. This very low estrogen‐dose combination was found to be a highly effective oral contraceptive preparation with a good cycle control. Only one pregnancy occurred (not a product failure). The frequency of absence of withdrawal bleeding was low (generally less than 6% during the initial treatment cycles, gradually decreasing to less than 3% after 20 cycles) and in most women the amount and duration of withdrawal bleeding showed no change or a slight decrease in comparison with those of the menstrual bleeding before treatment. The incidence of irregular bleeding (spotting and breakthrough bleeding) rapidly decreased over the subsequent treatment cycles, from 11.7% after 3 cycles to 8.8% after 6 cycles and less than 5% after 12 or more cycles. The preparation was well tolerated. There were no serious side effects and only 8 (2.7%) women dropped out because of minor side effe

ISSN:0001-6349    

DOI:10.3109/00016348709156489

出版商:Blackwell Publishing Ltd    

年代:1987

数据来源: WILEY

摘要:

Abstract.A multicenter trial was carried out by 13 independent German investigators to evaluate a new oral contraceptive combination containing 0.150 mg desogestrel+0.020 mg ethinylestradiol, paying particular attention to cycle control and efficacy. This German trial, being part of a larger European open multicenter study in 12 countries, comprised 235 women and a total of 5758 cycles. Despite the very low estrogen dose, this combination showed a good cycle control. The frequencies of absence of withdrawal bleeding and the occurrence of irregular bleeding, which were already low during the initial treatment cycles, gradually decreased over the subsequent cycles. In most women the amount and duration of withdrawal bleeding were similar to or slightly less than those of the menstrual bleeding before treatment. The combination showed a good contraceptive efficacy. 3 pregnancies (all 3 patient failures) occurred (in the larger European study comprising 1684 women and 25970 cycles, no other patient failures than these 3 German cases occurred; in addition there was one tablet failure). The preparation was well tolerated. There were no serious side effects and the frequency of minor subjective complaints was very low.

ISSN:0001-6349    

DOI:10.3109/00016348709156490

出版商:Blackwell Publishing Ltd    

年代:1987

数据来源: WILEY

摘要:

Abstract.The oral contraceptive combination 0.150 mg desogestrel + 0.020 mg ethinylestradiol (Mercilon®) was investigated in an open multicenter study with the objective of evaluating efficacy, cycle control and side effects in women aged 30 years or older. Sixty‐one investigators participated and included 434 women treated in a total of 7669 cycles. No pregnancies occurred, thus showing the combination studied to be highly effective. Furthermore, a good cycle control and an excellent acceptability were demonstrat

ISSN:0001-6349    

DOI:10.3109/00016348709156491

出版商:Blackwell Publishing Ltd    

年代:1987

数据来源: WILEY

摘要:

An open study on the effects of the oral contraceptive combination 0.150 mg desogestrel plus 0.020 mg ethinylestradiol on carbohydrate metabolism was carried out in healthy female volunteers. The study covered 6 cycles: a pretreatment cycle was followed by 3 treatment cycles, which in turn were followed by 2 post‐treatment cycles. Each treatment cycle consisted of 21 days of tablet administration, followed by a 7‐day tablet‐free period. This very low estrogen‐dose oral contraceptive combination induced a slightly, but statistically significantly, impaired glucose tolerance and a statistically significantly increased insulin response in an oral glucose loading test. These effects are comparable to those reported for other low‐dose oral contraceptives. Whereas treatment induced a slight but statistically significant increase in fasting plasma C‐peptide levels, it had no effect on fasting plasma glucose and insulin levels or on the amount of glycosylated proteins. The importance of these findings is discussed. It is concluded that further investigations are needed to determine whether the slight alterations in carbohydrate tolerance (the values always remained within normal ranges) are of clinical s

ISSN:0001-6349    

DOI:10.3109/00016348709156492

出版商:Blackwell Publishing Ltd    

年代:1987

数据来源: WILEY

摘要:

The effects of the low‐dose oral contraceptive combination 0.150 mg desogestrel plus 0.020 mg ethinylestradiol (EE) on lipid metabolism was investigated in two independent studies. In one study the effects of this preparation on lipid parameters in a group of 10 women were compared with those of a triphasic levonorgestrel plus EE preparation in a group of 13 women. In a second study the effects of 0.150 mg desogestrel plus 0.020 mg EE on the lipid composition of VLDL, LDL, HDL‐2 and HDL‐3 were investigated in a group of 10 volunteers. The assessments were made in blood samples taken before treatment, after 3 treatment cycles and one or two cycles after treatment was stopped. The desogestrel preparation induced an increase in triglycerides, phospholipids and apolipoprotein B. HDL‐cholesterol did not change, but the structural parts of the HDL particle, apolipoprotein A‐I and phospholipids, showed a marked increase in the group treated with the desogestrel preparation. In the comparative study there was no difference between the combination 0.150 mg desogest‐reI+0.020 mg EE and the triphasic levonorgestrel+EE preparation. The lipid compositions of VLDL, LDL, HDL‐2, HDL‐3 and VHDL did not change during treatment with the combination 0.150 mg desogestrel+0.020 mg EE. It can be concluded from this study that the combination 0.150 mg desogestrel+0.020 mg EE does not adversely affect lipid metabolism after 3 mont

ISSN:0001-6349    

DOI:10.3109/00016348709156493

出版商:Blackwell Publishing Ltd    

年代:1987

数据来源: WILEY

摘要:

The effects of the low‐dose oral contraceptive combination 0.150 mg desogestrel+0.020 mg ethinylestradiol (EE) on serum cholesterol (total cholesterol, HDL‐cholesterol and % HDL‐cholesterol in total cholesterol), sex hormone binding globulin (SHBG), apolipoprotein A‐I and glycosylated proteins and plasma antithrombin III activity were studied in 25 healthy fertile women. Blood samples were taken before treatment and after 1,3,6 and 12‐15 treatment cycles. The contraceptive combination had no effect on total cholesterol, glycosylated proteins or antithrombin III activity. During treatment there were small but significant increases in HDL‐cholesterol, % HDL‐cholesterol in total cholesterol and apolipoprotein A‐I and a substantial increase in SHBG. Thus the combination 0.150 mg desogestrel+0.020 mg EE appears to have no adverse effects on lipid metabolism, serum glycosylated proteins and plasma antithromb

ISSN:0001-6349    

DOI:10.3109/00016348709156494

出版商:Blackwell Publishing Ltd    

年代:1987

数据来源: WILEY

摘要:

The effects of three low‐dose oral contraceptive (OC) combinations on sex hormone binding globulin (SHBG), corticosteroid binding globulin (CBG) and anti‐thrombin III activity were studied in 44 healthy fertile women. In one study (study A) the effect of a 21‐day monophasic OC combination containing 0.150 mg desogestrel plus 0.030 mg ethinylestradiol (EE) was compared with that of a triphasic combination containing levonorgestrel/EE (6 days 0.050/0.O30 mg + 5 days O.O75/0.040 mg + 10 days 0.125/0.030 mg). In a second study (study B) the effect of a 21‐day monophasic combination containing 0.150 mg desogestrel plus 0.020 mg EE was evaluated. Fasting blood samples were taken before treatment, after 3 and 6 (study A only) treatment cycles and 2 months post‐treatment (study B only). Each treatment cycle consisted of 21 days of tablet administration followed by a 7‐day tablet‐free interval. Monophasic desogestrel/EE (0.150/0.030 mg) was found to induce a statistically significantly higher increase in SHBG levels than triphasic levonorgestrel/EE. This difference can be attributed to the lower intrinsic androgenicity of 3‐keto desogestrel (the biologically active metabolite of desogestrel) in comparison with levonorgestrel. Monophasic desogestrel/EE (0.150/0.020 mg) induced a similar increase in SHBG to that found with the 0.150/0.030 mg combination. All three preparations induced a twofold increase in CBG levels. Antithrombin III activity did not change with any of the preparations studied, suggesting no effect on the

ISSN:0001-6349    

DOI:10.3109/00016348709156495

出版商:Blackwell Publishing Ltd    

年代:1987

数据来源: WILEY