Phase III clinical trial with a new oral contraceptive containing 150 μg desogestrel and 20 μg ethinylestradiol

Abstract

Results are presented of a Phase III international multicentre trial to study the effect of a new low-dose oral contraceptive (OC) containing 20 micrograms ethinylestradiol and 150 micrograms desogestrel (Mercilon) regarding efficacy, cycle control, blood pressure, and acceptability. Altogether 1,684 women from 12 European countries were included in the study. Four pregnancies occurred, 3 of them patient failures, one tablet failure. The overall Pearl Index was 0.20. The frequency of irregular bleeding was comparable to that recorded with other commonly used low-dose OCs. No serious side effects occurred. The incidence of the most frequently reported subjective side effects--headache, nausea and breast tension--was already low after the first cycle of treatment and decreased to below pretreatment levels with continued use. There was a small increase in mean body weight, which was confined essentially to young women. The preparation did not affect the mean systolic or diastolic blood pressure. This new preparation has thus proved to be an effective, safe and well-accepted ultra low-dose oral contraceptive.

Improvement of quality of life in women using a low-dose desogestrel-containing contraceptive: results of an observational clinical evaluation

“…Improvements in nausea, headache, nervousness, depressive moods or breast tenderness were also seen in more than half of women reporting these symptoms at baseline. The improvement in subjective symptoms with the 20 mg ethinylestradiol plus 150 mg desogestrel combination observed during normal daily usage is consistent with those seen previously in clinical trials 7,9,[16][17][18][19] .…”

“…The monophasic combination preparation containing 20 mg ethinylestradiol and 150 mg desogestrel has a high contraceptive reliability with a Pearl Index of 0.18 6 . The preparation produces good cycle control with shorter and lighter withdrawal bleeding [7][8][9] , is well tolerated, having no significant effect on body weight and a low incidence of subjective side-effects such as nausea, headache and breast tenderness 7,9 . The low androgenic activity of desogestrel may result in beneficial effects on problems such as hirsutism and skin disorders when administered in combination with ethinylestradiol 6,10 .…”

Weight gain on the combined pill--is it real?

“…Such changes in weight in young women are more likely to re¯ect a consequence of natural growth than a result of COC use (Rekers et al, 1988). Such small increases in body weight are comparable to body weight demographics in women not using COCs (Lammers and Berg, 1991). These studies appear to be of little scienti®c merit, as they have never been compared with a similar group of women not using COCs and fail to include controls.…”

To Study the Acceptability and Efficacy of Combined Contraceptive Vaginal Ring Amidst Indian Women

“…(1)(2)(3)(4)(5) But these oral contraceptives have some unavoidable disadvantages like first-pass metabolism, large fluctuations in serum hormone levels and poor compliance in some users (6)(7)(8) for which non-oral hormonal methods have been tried with their own drawbacks. (9,10) One of the advances in the contraceptive field has been the development of combined contraceptive vaginal rings (CCVRs).…”