Twelve years of clinical experience with an oral contraceptive containing 30μg ethinyloestradiol and 150μg desogestrel

• Published in: Contraception (Stoneham) Vol. 51; no. 1; pp. 3 - 12
• Main Author: Fotherby, K.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 1995; Elsevier Science
• Subjects: Biological and medical sciences; Birth control; clinical trials; desogestrel; Gynecology. Andrology. Obstetrics; Hormonal contraception; hyperandrogenism; Medical sciences; metabolism; oral contraceptive; skin disorders; clinical trials; metabolism; desogestrel; hyperandrogenism; oral contraceptive; skin disorders; Ethinylestradiol; Human; Estroprogestagen; Estrogen; Oral administration; Female; Contraceptive; Contraception; Review; Progestagen
• DOI: 10.1016/0010-7824(94)00010-T
• ISSN: 0010-7824

The clinical experience with a combined oral contraceptive (COC) containign 150 μg desogestrel and 30 μg 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 consequent 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 COC. The findings from the various trials show the COC to be effective and acceptable with no adverse metabolic effects.