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The oral contraceptive combination of ethynodiol diacetate with ethinyl estradiol (Demulen) was given cyclically to 48 female rhesus monkeys for 5 years. Doses employed were 1, 10, and 50 times the human dose. Treatment did not induce palpable breast nodules, and there were no deaths from mammary gland cancer.
An open-label, phase IV, multicenter survey of obstetrician-gynecologists was conducted to evaluate the efficacy and safety of a low-dose monophasic oral contraceptive, ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms. Surveys from 983 community-based physicians reported on 6,382 women. Most patients did not experience "clinically noticeable complexion changes" (5,695/6,382, or 89.2%). Of the 687 patients with complexion changes, nearly three-fourths reported an improvement (501/687, or 72.9%). A follow-up questionnaire was sent to 127 respondents (18.6%) who reported worsening of the complexion; 70% of the questionnaires were returned. Most complexion worsening was of slight degree (63%), reported by the patient and not the physician (84% vs. 16%), and experienced during the first two to three months (84%). Although the literature includes many references to skin condition "improvement" on oral contraceptives, this report of a descriptive study gives clinicians as estimate of the incidence and severity of complexion changes in actual use.
Blood glucose and plasma insulin levels were measured in two groups of women, following one year of oral contraceptive therapy of different types. There were no significant differences from pretreatment glucose and insulin values in the first group of women (on ethynodiol diacetate). In the second group (on norethynodrel and mestranol), there was a significant elevation of mean blood glucose levels in the fasting state and at all times of an i.v. glucose tolerance test. Furthermore, a statistically significant alteration in plasma insulin was observed at all times of the test (except at 120 min). Patients participating in this study will continue this treatment, and results of carbohydrate metabolism monitoring will be reported after 2 years of therapy.
Treatment of adult female rats with Ovulen-50 (ethynodiol diacetate 1.0 mg and ethynyloestradiol 0.05 mg--one tenth tablet per day) led to a small but significant fall in total protein, RNA and DNA content of the liver. Alkaline and acid DNAse activity also tended to decline, whereas alkaline RNAase tended to show a marginal rise after twentyfour days of treatment.
A 3-hour oral glucose tolerance test was conducted in "normal" women before and after 12 months of contraceptive treatment with daily 0.25-mg ethynodiol diacetate tablets. There was no significant change in the subjects' weight between the two tests. All but the 3-hour individual group glucose values were significantly elevated at the 1-year test, and 16.7% of the tolerance curves became "borderline abnormal". The group plasma insulin values for the 0.5-, 1-, and 2-hour samples during the 1-year test were also significantly elevated. There was a significant decrease in the group fasting triglyceride levels but no change in the fasting cholesterol levels. These data suggest that some of the 19-norprogestogens may adversely affect carbohydrate metabolism.
Absorption, distribution, excretion and metabolism of SC-11800EE, a combined steroid preparation consisting of SC-11800(ethynodiol diacetate)as gestagen and ethinyl estradiol (EE)as estrogen in 20:1 (w:w), were studied with the use of 14C-SC-11800 and 3H-EE by radiometry in female rats and by the whole body autoradiography in female normal and pregnant mice. The gestagen orally given with EE was rapidly absorbed from digestive tracts and distributed in tissues in various levels. Gestagen levels in liver and kidney exceeded that in plasma. About 75% of dosed radioactivity was excreted in feces largely via bile and more than 20% in urine within 72 hr after administration. The gestagen was metabolized extensively to more polar products and their conjugates. The pharmacokinetic behavior of the gestagen given with EE did not alter after repeated administrations for 7 days, but was slightly different from that without EE, possibly due to the estrogen effect. The pharmacokinetic behavior of the estrogen was independent from the gestagen given simultaneously. The distribution of the gestagen given with EE revealed by the whole body autoradiography in normal mice were essentially consistent with the radiometric results in rats and that in the pregnant mice showed that the gestagen in fetus was virtually nil under the present conditions.
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Ethynodiol (17alpha-ethinyl-4- estrene-3,17-diol) diacetate, a potent progestin and oral inhibitor of ovulation in the rabbit, gives evidence of possessing antiovulatory activity when it is administered orally to women. When it is combined with an estrogen it provides adequate control of menstrual cyclicity, and, thus far, complete contraceptive effectiveness even in low daily doses.
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