Original research articleThe effects of two progestogen-only pills containing either desogestrel (75 μg/day) or levonorgestrel (30 μg/day) on lipid metabolism☆
Introduction
The progestogen-only pill (POP) is a suitable alternative to oral contraceptives containing a combination of estrogen and progestogen. However, because of their lower contraceptive efficacy and unpredictable bleeding pattern, the POPs that have been available until now have generally been less well-accepted than combined oral contraceptives by both prescribers and users. Consequently, the traditional POPs have mainly been reserved for specific groups of women, such as women with contraindications for estrogens.
Etonogestrel, the biologically active metabolite of desogestrel, is a selective progestogen that combines high progestogenic activity with a lower intrinsic androgenicity than those progestogens used in traditional POPs [1], [2]. As a result of its intrinsic low androgenicity, it is anticipated that a higher daily dose of desogestrel would consistently inhibit ovulation, without triggering androgen-related effects on lipid and carbohydrate metabolism and on the skin. Ovarian function has been shown to be dose-relatedly suppressed with daily doses of 30, 50, and 75 μg of desogestrel [3]. Of these doses, the optimal one was found to be 75 μg because it showed the highest extent of ovarian suppression and a more acceptable bleeding pattern than the lower doses. In a double-blind, multicenter study involving over 1000 participants, desogestrel 75 μg/day (Cerazette) was shown to inhibit ovulation in 98% of cycles, and to have a higher contraceptive efficacy and a similar overall acceptability, than levonorgestrel 30 μg/day [4]. The aim of the present study was to compare the effect of desogestrel 75 μg/day and levonorgestrel 30 μg/day on lipid metabolism in healthy female volunteers.
Section snippets
Materials and methods
A randomized, double-blind study was conducted at two study sites, one in Sweden and one in Finland, to compare the effect of desogestrel 75 μg/day and levonorgestrel 30 μg/day on lipid metabolism in healthy female volunteers. The study was conducted in accordance with the Declaration of Helsinki guidelines and approved by the relevant ethics committees. Written, informed consent was obtained from each participant prior to participation in the study.
Results
A total of 98 healthy women were recruited to this study and randomized to receive either desogestrel 75 μg/day (n = 49) or levonorgestrel 30 μg/day (n = 49). Seventeen patients (eight desogestrel and nine levonorgestrel) did not actually take any study medication, leaving 41 desogestrel participants and 40 levonorgestrel participants who received treatment. In total, 13 participants (7 desogestrel, 17.1%, and 6 levonorgestrel, 15.0%) discontinued prior to completion of the study: 5 women (2
Discussion
This double-blind, two-center, randomized study of healthy female volunteers was carried out to compare the effect of desogestrel 75 μg/day with levonorgestrel 30 μg/day on various parameters of lipid metabolism.
Overall, the study results show that the effect on lipid parameters appeared to be minimal with both desogestrel 75 μg/day and levonorgestrel 30 μg/day. There was no effect on LDL-cholesterol and apolipoprotein B and only small decreases in total cholesterol, triglycerides,
Acknowledgements
The authors thank Lisette Vromans and Moki Vree for their editorial contributions to the manuscript.
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This study was sponsored by NV Organon, Oss, The Netherlands.