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Se estudió una formulación oral monofásica a base de 75 mcg de gestodeno y 30 mcg de etinilestradiol, con el objeto de probar su seguridad, eficacia y control del ciclo menstrual. En el estudio se incluyeron 67 mujeres sanas que acumularon 574 ciclos. Esta formulación mostró ser muy eficaz, ya que con el uso adecuado del método no se presentó ningún embarazo. los efectos secundarios observados fueron iguales o menores a los reportados con otros anticonceptivos hormonales orales. La administración de este nuevo preparado no modificó los parámetros hematológicos, bioquímicos o urinarios de las usuarias. Con respecto al control sobre el sangrado endometrial, las usuarias de mantuvieron dentro de un patrón menstrual considerado como acptable. En conclusión, se trata de un anticonceptivo oral que resultó ser eficaz, bien aceptado y cuyos efectos secundarios son semejantes o menores a los de otros anticonceptivos orales.

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Liver D-3-hydroxybutyrate dehydrogenase (OHBD) is subjected to estrogen modulation. Estrogen action was demonstrated by (a) the lesser activity of liver OHBD in female rats, as compared with their male counterparts; (b) the increase of OHBD activity after ovariectomy of sexually mature rats; (c) the decrease of OHBD activity after treatment of gonadectomized or normal rats with 17 beta-estradiol or with artificial estrogens; (d) the decrease of OHBD activity in female rats during sexual development; (e) the effects of tamoxifen on the enzyme activity. The kinetics of OHBD reaction using liver mitochondria from estrogen-treated rats showed a 50% decrease of Vmax, as compared with the control value, in contrast to the other parameters which did not vary. These results, taken together with the effect of estrogens on liver mitochondrial phospholipids, point to a decreased content of OHBD in liver mitochondria from estrogen-treated rats. In contrast to OHBD, succinate dehydrogenase and cytochrome oxidase activities, mitochondrial protein synthesis and L-malate + L-glutamate oxidation by coupled liver mitochondria either increased or were not affected by estrogens. Kidney and heart OHBD were affected by ovariectomy and estrogens like the liver enzyme, though to a lesser degree.

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To study the question of whether one brand of oral contraceptives may be as acceptable as another for use of publicly-assisted family planning programs, a double blind study of two well-known brands, Ovral and Norinyl, was undertaken in Costa Rica and Trinidad. The pills were randomly assigned to 1,200 women. Common side effects - nausea, dizziness, vomiting, headaches - were associated with both Norinyl and Ovral. Differences in event rates for these conditions were much more marked by country than by the pill used. Ovral was associated with increases in skin problems, notably chloasma, in Cost Rica. A higher percentage of women using Norinyl reported intermenstrual bleeding and spotting in both countries. In Costa Rica continuation rates for Norinyl were adversely affected by this. With these exceptions there appear to be no important differences between the brands that would affect their use in family planning programs.

PIP: A double-blind study of 2 well-known brands of contraceptives, Ovral and Norinyl, was performed in Trinidad and Costa Rica to determine if 1 brand of oral contraceptive were as acceptable as another. Differences in race and ethnic origin were large between the 2 study populations. There were no significant differences in reporting of gastrointestinal side effects for the 2 formulations. Women using Ovral in Costa Rica reported acne and chloasma in significantly greater (P .001) numbers than did women using Norinyl. Participants in Trinidad were virtually free of such complaints. Overall in both study populations, Ovral affected significantly more users (P .05) both with regard to chloasma and all skin conditions than did Norinyl. A moderate excess of cervicitis and cervical erosion among Ovral users in Trinidad was seen; in Costa Rica, cervical erosion occurred in 13% of users of either drug, whereas cervicitis was noted in 3% of each group. Both brands reduced the average number of days of menstrual bleeding in the 2 countries, and both formulations effected a reduction in the % of women reporting relatively heavy menstrual flow. Intermenstrual spotting or bleeding was strongly (P .001 overall) associated with the use of Norinyl; in both countries, the % of women using Norinyl reporting intermenstrual bleeding was at least 2 times that of Ovral users. In Costa Rica, continuation rates for Norinyl were badly affected by the frequency of intermenstrual bleeding (27.9 for Norinyl and 8.2 for Ovral). Otherwise, it is concluded that there were no important differences between the 2 formulations.

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To study the question of whether one brand of oral contraceptives may be as acceptable as another for use in publicly-assisted family planning programs, a double blind study of two well-known brands, Ovral and Norinyl, was undertaken in Costa Rica and Trinidad. The pills were randomly assigned to 1,200 women. Common side effects - nausea, dizziness, vomiting, headaches - were associated with both Norinyl and Ovral. Differences in event rates for these conditions were much more marked by country than by pill used. Ovral was associated with increases in skin problems, notably chloasma, in Costa Rica. A higher percentage of women using Norinyl reported intermentstral bleeding and spotting in both countries. In Costa Rica continuation rated for Norinyl were adversely affected by this. With these exceptions there appear to be no important differences between the brands that would affect their use in family planning programs (AU)

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PIP: Experience with the oral contraceptive Ovostat (.1 mg mestranol and 1 mg lynestrenol) in 324 women (5714 cycles) is reported. Only 1 pregnancy was observed, in a patient who had forgotten several pills. Side effects included headache (11 patients), nervousness (5 patients), amenorrhea (4 patients), and chloasma (3 patients). Breakthrough bleeding and spotting were rare. Cervical mucus (samples on Days 9-11 and 13-15 in 50 women) was uniformly inhospitable to sperm: low viscosity, negative Farn test, constant pH. Endometrial biopsy showed tissue typical of "suppressed" endometrium.^ieng

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PIP: 100 healthy fertile women, with active sexual lives and of reproductive age, were treated during 10 cycles in 1 year with mestranol-lynestrenol of the sequential type, for the purpose of determining the effectiveness of the drug as a contraceptive and study its effects on endometrial morphology, endocervical mucus, cervicovaginal cytology and urinary excretion of pregnanediol. The changes in the menstrual cycle and side effects were observed. The results obtained clearly show that the combination of mestranol-lynestrenol is an effective contraceptive (no pregnancy occurred), safe and well tolerated, with minimal side effects.^ieng

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PIP: Medical histories of 436 patients treated with Ovulen after childbirth or an abortion were examined in order to collect a sample of women who had taken the orals for 6-12 cycles. A group of 70 patients was thus formed. The following parameters were investigated: weight variation; blood pressure; nausea and vomiting; varicosities; variation in menstrual flow and length of period; breast-related side effects; jaundice; psychic alteration, i.e., nervousness, anxiety, or depression; changes in libido; headaches; skin changes; and pregnancy. Results are presented both in graph and table form. Weight change was found to tend more to loss than to gain. No statistically significant changes in blood pressure were observed. Nausea and associated symptoms tended to disappear after the 9th cycle. Edema was present in only 6% of all cycles. The most common side effect was varicosities, present in 25% of the sample, but in no instance did thrombosis occur nor was varicosity a cause for discontinuation in any case. Breast-related side effects were more common at the outset. No jaundice was observed. Psychic alterations were not common and were mostly insignificant and tended to occur more frequently at the outset. 12% of the sample had headaches from the beginning of treatment up until the 8th month, after which they began to disappear. Only 1 patient had chloasma and then only during the 1st 2 cycles. There was a marked tendency toward menorrhagia which was thought to be beneficial due to the prevalence of anemia in the group. Changes in libido were minimal and tended to disappear after the 8th cycle. None of the patients became pregnant.^ieng

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