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  • Title: [Thirty years after the appearance of the first oral contraceptive, clinical and biological analysis of a new estrogen-progestin combination, a three phase pill containing gestodene].
    Author: Belaisch J, Hommais-loufrani B.
    Journal: Fertil Contracept Sex; 1988 Apr; 16(4 Suppl):1-8. PubMed ID: 12342078.
    Abstract:
    Combined oral contraceptives (OCs) are used by approximately 55 million women throughout the world. Given their effectiveness, easy use, and good tolerance, they will probably continue to be the most used contraceptive method in the developed world for years to come. Research therefore continues with a view to minimizing the rare but serious complications of OCs. Development of new progestins and decreasing of dose levels are 2 goals. The hormonal properties of natural progesterone are well defined. Synthetic progestins have 3 major advantages over natural progesterone: better bioavailability by the oral route, superior progestomimetic activity, and more marked antiestrogenic and antigonadotropic effects. Of the 2 large chemical classes of progestins, those derived from progesterone are primarily used in therapy while those derived from nortestosterone are used in both therapy and contraception. Within these classes, each progestin has a specific pharmacologic profile which determines its uses. The major advantage of the norsteroids for contraception is their strong antiovulatory action, but their varying androgenic properties are responsible for undesirable cutaneous and metabolic side effects. Gestodene, a new progestin, combines a strong antigonadotropic and progestomimetic action with an absence of androgenic and estrogenic effects at contraceptive doses. Tests in rats and mice demonstrate that gestodene inhibits ovulation in 100% of cases at 1/3 the dose of levonorgestrel. The threshold dose for women is the lowest of any of the gonane progestins. Tests of endometrial transformation and affinity to progesterone receptors indicate that gestodene is 3 to 30 times more active than levonorgestrel. Gestodene's strong luteomimetic activity assures reinforcement of contraceptive control by endometrial transformation and permits creation of hormonal balance. Because of its weak androgenic character, gestodene at contraceptive doses causes no modification in lipid or glucose parameters in animals. A new triphasic OC containing gestodene combines 3 successive phases lasting 6, 5, and 10 days with 50, 70, and 100 mcg of gestodene and 30, 40, and 30 mcg of ethinyl estradiol respectively. At these doses the inhibition of ovulation was shown by pelvic sonography, serum levels of estradiol and progesterone, and other tests to be constant. A multicenter study of 27,308 cycles showed a Pearl index of .1 despite forgetting of pills in 669 cycles. The rate of amenorrhea was .3%. Cycle control was excellent. Various studies of the effect on lipid and glucose parameters and on hemostasis demonstrated a high degree of tolerance consistent with the low steroid dose and minimal androgenicity of the progestin.
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