Authors:

Fotherby K.

Institution

Royal Postgraduate Medical School, Ducane Road,London W12 0NN; United Kingdom.

Title:

Twelve years of clinical experience with an oral contraceptive containing 30mug ethinyloestradiol and 150mug desogestrel (1995-2109a).

Source:

Contraception. Vol 51(1) (pp-12), 1995.

Abstract:

The clinical experience with a combined oral contraceptive (COC) containing 150 mug desogestrel and 30 mug ethinylestradiol is reviewed. Fourteen clinical trials have been reported involving over 44,000 women for more than 190,000 cycles. None of the 17 pregnancies which occurred (overall Pearl Index 0.12) were due to method failure. The incidences of breakthrough bleeding and spotting after 6 treatment cycles varied from 0.1-6.0% and 2.8-11% of subjects, respectively, and at this time they were not significantly different from pretreatment in most trials. About 90% of subjects maintained regular cycles. The incidence of subjective side effects (approximately 5% for headache, 4% for breast tenderness, 2% for nausea) was low No significant changes occurred in body weight or blood pressure. In all trials, the COC was well accepted and the rates of discontinuation were similar to those in other COC trials. Pharmacodynamic effects have been widely investigated. There were no significant changes in glucose metabolism or in haematological factors except for possibly minor increases in factors VII and X, fibrinogen and plasminogen. Over thirty studies of the effect of the COC on lipid metabolism have been published; significant increases occur in serum triglycerides, HDL-C and apoprotein A1. SHBG concentrations increase 2-3 fold with a conse quent decrease in the levels of free testosterone. This effect can be particularly important therapeutically in women with hyperandrogenic skin disorders and 14 trials in women with these disorders have demonstrated significant clinical improvement with the COG. The findings from the various trials show the COC to be effective and acceptable with no adverse metabolic effects.


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