Serium protein-bound carbohydrate and seromucoid levels during long-acting progestational contraceptive therapy.
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Norethisterone enanthate (NET-EN) was intramuscularly administered to 5 puerperal women and 20 non-puerperal women for a total of 366 months. Contraceptive effectiveness and side effects of the drug were evaluated. Basal levels of LH, FSH, prolactin (PRL), estradiol 17 beta (E2) and progesterone (P) were measured in blood samples collected from 5 non-puerperal women, while LH, FSH, PRL and norethisterone (NET) plasma levels were evaluated in puerperal women. NET was also assayed in plasma from breast-fed newborns. No woman became pregnant. Side effects consisted of only menstrual abnormalities. Ovulation (P plasma levels higher than 2000 pg/ml) was achieved in 3 patients during the first month of NET-EN treatment but luteal function appeared to be insufficient. In puerperal women, NET plasma levels showed a course similar to the one observed outside puerperium. Lactation was not inhibited, and NET transfer to newborn through milk was negligible, since NET was undetectable in newborn plasma when maximal levels were measured in the mother. It was concluded that NET-EN is an effective contraceptive drug, deprived of major side effects, and particularly useful in women affected by metabolic diseases or during puerperium.
A clinical trial was carried out in which Norigest (200 mg norethisterone oenanthate) was administered by intramuscular injection every 56 days into 383 women studied for 5,521 woman-months of use. No pregnancies occurred. Continuation rates at the end of one, two and three years were 76.6%, 63.7% and 33.8%. Only minor side-effects were recorded. After one year of use, 20.1% women had gained more than 2 kg in weight and 14.8% had lost more than 2 kg. There was marked disruption of the menstrual pattern and irregular bleeding was the major cause of discontinuation. In 38% of the injection intervals analysed, women were amenorrhoeic. Norigest proved an effective and acceptable method of fertility control.
Lipid concentrations were measured in 74 blood samples from 61 women who had been using the injectable contraceptive Norigest (norethisterone oenanthate) for between 2 to 4-1/2 years. There were no significant changes in the concentrations of total cholesterol, total triglycerides and low density and very low density lipoprotein cholesterol but high density lipoprotein cholesterol was significantly reduced. The reduction in serum HDL-C levels was not correlated with either the serum norethisterone concentrations or the length of use of Norigest nor was it affected by obesity or smoking.
To test the efficacy and tolerance of progestagens as contraceptives in systemic lupus erythematosus (SLE), 200 mg IM norethisterone enanthate was administered to 10 patients, 0.03 mg/day oral levonorgestrel to 15 patients and they were compared with 18 control patients. There were 4 episodes of active SLE in 48 patient-months on norethisterone enantate and 6 episodes in 122 patient-months on levonorgestrel as compared with 9 episodes of active disease in 298 control patient-months (p = ns). There were no pregnancies and intermenstrual bleeding led to discontinuation of medication in 30% of patients. Progestagens may be an alternative contraceptive method in SLE.
Endometrial bleeding and alteration in blood coagulation, fibrinolysis, ovarian function and endometrial morphology were studied in twelve normally menstruating women who received the injectable contraceptive norethisterone enanthate (NET-EN) 200mg at 60-day intervals. Levels of clotting factor VII declined significantly during episodes of irregular bleeding compared to those during both normal pretreatment menstruation and the bleeding-free period during treatment. Antithrombin III and fibrinolytic activity, expressed by euglobulin lysis time, showed no marked change. The average level of progesterone during the bleeding-free period was slightly but significantly lower than that during the bleeding period. There were no significant alterations in the mean levels of estradiol and the ratio of estradiol to progesterone. The endometrial biopsies showed considerable individual variation and seem to be independent of the effects of NET-EN on ovarian function.
Intravenous glucose tolerance tests, and estimations of prothrombin time, and plasma coagulation factors VII and X, were made on 12 women receiving 200 mg norethisterone oenanthate intramuscularly as a contraceptive. These estimations were made before, and at 2 and 12 weeks after, a single injection of norehisterone oenanthate. There was no significant effect on the intravenous glucose tolerance, prothrombin time, or on plasma coagulation factors VII and X, further confirming the safety of norehisterone oenanthate when used as a short-term injectable contraceptive.
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Injectable progestogen, norethisterone enanthate (NET-EN, 200 mg/ml) was administered to 122 women at 2 month intervals for more than 1 year. Only a minority of women had consistently normal cycles. Most women experienced some menstrual irregularities: 57% of users experienced irregular bleeding, 32% developed amenorrhea, while only 11% showed regular cyclic bleeding. Important nonmenstrual side effects were weakness and abdominal pain. No appreciable changes in body weight and blood pressure were recorded.
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