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  • Title: [Contraception with pure, synthetic progestogens of the norpregnane group, a new approach for the future?].
    Author: Rozenbaum H.
    Journal: Contracept Fertil Sex (Paris); 1986 Jun; 14(6):577-81. PubMed ID: 12341096.
    Abstract:
    The 19-norsteroid androstanes which are currently the most prescribed progestin-only oral contraceptive formulations are responsible for some undesirable metabolic effects. The lowering of high density lipoprotein cholesterol and increased peripheral resistance to insulin associated with their use make them unsuitable for prolonged treatment. The norpregnanes, a new family of progestins, do not appear to induce similar metabolic modifications because they lack the same androgenic properties. The norpregnane group is characterized by persistence of the terminal chain of progesterone in 17 and absence of the methyl radical in 19. 3 norpregnanes have been tested in contraception: promegestone, nomegestrol acetate, and ST-1435 which is not yet commercially available. Levels of folicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone were monitored daily to confirm that ovulation was inhibited in all cases. A minimum dosage was found to be necessary in all cases to avoid continuing secretion of estrogen, which otherwide reached levels higher than those occurring in normal menstrual cycles. 6 women receiving 500 mcg of promegestone/day from the 6th to the 25th cycle day had no preovulatory FSH or LH peak, progesterone was constantly unmeasurable, and the plasma estradiol level dropped very quickly after the 1st days of treatment and remained between about 10-80 pcg/day. At doses of 2.5-5 mg/day of nomegestrol acetate, the preovulatory peak of LH disappeared, progesterone was unmeasurable, and the plasma levels of estradiol diminished within a few days. In a separate study, ST-1435, in the form of long-acting subcutaneous capsules, was found to inhibit the preovulatory peak of the gonadostimulants as well as progesterone secretion. Differences were again observed according to the dose level utilized, and fewer than 3 capsules of 40 mg ST-1435 permitted follicular maturation with high levels of plasma estradiol. The small number of women studied does not permit conclusions about clinical tolerance of the norpregnanes, but some cases of breakthrough bleeding were observed in women treated with promegestone and nomegestrol acetate. Biological tolerance was studied in a fragmentary fashion for promegestone. No weight gain or diminution of high density lipoprotein cholesterol was observed. The plasma TeBG level did not decline, confirming the absence of androgenic properties. The fasting glucose level, total cholesterol level, and triglyceride levels were unchanged.
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