A Clinical Comparison in Finland of Two Oral Contraceptives Containing 0.150 mg Desogestrel in Combination with 0.020 mg Or 0.030 mg Ethinylestradiol

Abstract

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.

Low‐dose combined oral contraceptives

“…The data in Table 2 illustrate rates of breakthrough bleeding, spotting and amenorrhoea, with monophasic COCs containing the new progestogens. These figures, which represent cycle control in the six month of pill use, are from various studies which are non‐comparative (Tuimala 1987; Hoppe 1988; Chen 1989; Corson 1990; Dusterberg 1990; Kafrissen 1992; Kaunitz 1993; Speroff 1993). The definitions of cycle irregularities vary; spotting is light bleeding requiring either no or, at most, one sanitary towel protection.…”

“…Most are of insufficient duration to assess long term effects. The most usual outcome measures are the areas under the glucose and insulin curves during oral glucose tolerance tests (Schijf 1983; Bergink 1984; Fotherby 1987; Rabe 1987; Tuimala 1987; van der Vange 1987; Petersen 1988; Ball 1989; Fioretti 1989; Ball 1990; Carson 1990; Granata 1990; Huber 1991).…”

Oral Contraceptives Containing 20 or 30 μg Ethinylestradiol and 150 μg Desogestrel: Pharmacokinetics and Pharmacodynamic Parameters

“…Twenty years ago, 50 pg EE had been regarded as the minimal dose, while in modern pills, 30 pg have been suggested as the lowest acceptable dosage. Indeed, a combination of 20 gg EE and 1 mg norethisterone caused a relatively high rate of irregular bleedings [6], There is, however, considerable evidence that the type and dose of the progestogen component is the critical factor [7,8], The experience with a new for mulation containing 20 gg EE and 150 gg desogestrel actually demonstrated that the cycle control is not differ ent from that during treatment with a combination con taining 30 gg EE and 150 gg desogestrel (DG) [9][10][11][12][13]. The present report describes the results of two compara tive studies on the pharmacokinetics and some pharma codynamic parameters of two oral contraceptives con taining 150 gg DG and 20 or 30 gg EE.…”