A comparison of a new graduated estrogen formulation with three constant-dosed oral contraceptives.

Four-hundred-twenty-six women, aged 18 to 36, completed a four-cycle comparative, randomized, single-blind (observer blind), multicenter study of a new graduated estrogen formulation with three constant-dosed combination oral contraceptives containing the same synthetic steroid compounds. The products studied were Loestrin 1/20, Loestrin 1.5/30, Norlestrin 1/50, and a new graduated estrogen product, Estrostep. A total of 1,850 cycles were completed and analyzed for efficacy, side effects, metabolic changes, and cycle control. Four pregnancies occurred during the course of the study. None of the pregnancies occurred in the group receiving Estrostep. The new formulation produced the lowest rate of breakthrough bleeding (BTB) compared with the other three products. All four combination oral contraceptives resulted in an increase in high-density lipoprotein cholesterol (HDL-C). The levels of HDL-C were greatest with Estrostep.

[Injectable contraception using depot progestagens]. / Anticoncepción inyectable con progestágenos de depósito.

PIP: After 20 years of clinical experience, injectable hormonal contraceptives such as norethisterone enanthate (NET) and medroxyprogesterone acetate (MPA) remain one of the most controversial methods currently used for temporary control of fertility in women. Since December 1980 this controversy has been accentuated in Mexico with issuing of regulations by the Secretary of Health and Welfare which initially did not permit promotion of long-acting injectable hormones for contraception purposes, and later, in June 1981, a reconsideration which exclusively authorized use of NET as an injectable contraceptive. Undeniably these official measures and the scientific information, occasionally contradictory, have created confusion about the indications and risks of using these formulations in clinical work. This paper presents an anlysis of the basic pharmacological aspects of long-acting contraceptive progestagens, potential risks for side effects, and some clinical rules for safe use. The authors conclude that injectable contraceptives will continue holding a definite place among hormonal methods of temporary fertility control, particularly with the advent of new administration schemes for NET which have elevated its contraceptive efficacy without appreciably increasing complications. The more rapid metabolism of NET, manifested in the absence of significant effects on body weight, less alteration of the menstrual cycle, and more rapid return of fertility after discontinuation, has considerably increased its popularity, and the possibility exists that with time and an increase in clinical experience, it may replace MPA as the injectable contraceptive of choice. Nevertheless, while investigative studies have not clearly defined the possibilities of potential risk of using these contraceptives, its clinical use must be governed by appropriate selection and careful follow-up of patients.^ieng

[Comparison in changes in blood coagulation tests during use of oral contraceptives. First symposium - sexual steroids]. / Comparacion de la modificacion en algunas pruebas de coagulacion por el uso de tres anticonceptivos orales. Primer simposio - esteroides sexuales

PIP: 284 women using 3 types of oral contraceptives were studied for 1 year. The drugs used were: SH-70840, containing 0.050 mg of ethinyl estradiol and 1 mg of ethinyl nortestosterone acetate; SH-70876, containing 0.075 mg of ethinyl estradiol and 1 mg of ethinyl nortestosterone acetate; and SH-70850, containing 0. 050 mg of ethinyl es tradiol and 0.50 mg of norgestrel. The average results were within normal limits. Of the 3 groups, 2 (using SH-70840 and 70876) showed a slight increase in blood coagulation. The tests, conducted with properly selected patients, showed no cases of thrombosis.^ieng

[Study of various metabolic effects of a contraceptive used for a prolonged period]. / Estudio de algunos efectos metabólicos de un gestágeno usado en forma prolongada.

PIP: The use of oral contraceptive appears to be associated with alterations in glucose tolerance and slight increases of plasma free fatty acids and triglycerides. In this study, the glucose disappearance constant and the plasma levels of nonesterified fatty acids were studied in 63 women, carefully selected with respect to age (20-30 years), parity (less than 4), normal body weight for height and age, absence of obstetric or family precedents suggesting diabetes mellitus, and absence of other pathological conditions. The oral contraceptive (Norlestrin, Parke Davis) was administered during 1 year, starting between the 7th and 9th week of puerperium. Clinical and laboratory tests were performed before the administration of the drug, and after 3, 6, and 12 months. The number of patients was reduced to 36 at the 1st control, 30 at the 2nd, and 24 at the 3rd. A progressive deterioration of the glucose disappearance constant was observed, with significant differences (p less than .001) between the values before and 12 months after treatment. Diabetic-level values were absent. The plasma nonesterified fatty acids showed a progressive and significant increase, interrupted only during the glucose tolerance tests. There was an average increase in body weight of 4 kg at the 1st control, followed by normalization at the 12th month of treatment. The study discusses the possible causes of such alterations, emphasizing the role of many functi ons that maintain metabolic homeostasis.^ieng

[Suppression of lactation by using a trihormone preparation]. / Inhibición de la lactanca mediante un preparado trihormonal.

PIP: Ablacton, and andro-estro-progestagen hormone combination, was administered to 59 postpartum and postcurettage patients to suppress lactation: primary inhibition was attempted in 40 cases and secondary in 19. In primary suppression, results were excellent in 83.5% of the cases, good in 10.0% and bad in 2.5%. In secondary suppression, results were excellent in all cases. The suppression of lactation was total and permanent. Tolerance to medication was very good. Because of the very small number of cases and the type of study, the study is limited to this single product.^ieng

Steroids.

PIP: The structure, sources, synthesis, economics, and the present and future marketing of male and female sex steroids and corticoids are summarized. Physiologically, and historically in industry, steroids were made from cholesterol. Now most steroids are produced from diosgenin, an akaloid from the Mexican Dioscorea plant. Other sources are stigmasterol from soybeans, hecogenin from sissal waste, bile acids, and total synthesis. Unlike prices of corticoids which have been low for lack of patent protection, prices of sex steroids, especially oral contraceptives, have fallen only 50%, although doses have decreased 90%. There are 735 million women of fertile age, so prices could fall to an unlikely $1 per year without hurting sales. The major companies and subsidiaries, patent holders, and licencees of steroids in South America, U.S., Europe, Iron Curtain countries, Asia, and Africa were listed with their products. In the future oral contraceptives will be joined with minipills, injectables, once monthly pills, and steroid treatment of menopause. Postcoital pills and pills taken for delayed menses may be developed, but used clandestinely because of government and moral barriers. Corticoids are now used an analogs, with a growing market for topical ointments. Steroids will find uses in domestic animal estrus control, rat control, and insect hormones isolated from plant sources for insect control.^ieng

[Effects of different contraceptives upon the ovulation changes of the morphological study of the ovaries].

PIP: Bilateral ovarian wedges were performed on 46 patients scheduled for laparotomies for medical reasons. Prior to the operation, the patients were divided into 5 groups and treated as follows: 1 for control (5 patients); 1 that was given 1 of 3 different combined oral contraceptives, i.e., Anovlar, Gynovlar, or Engynon (22 patients); 1 that was given Sequens (3 patients); 1 that was injected with 200 mg of norethindrone enanthate (14 cases); and 1 given IUDs (2 cases). It was established that all experienced ovulatory cycles prior to therapy. The laparotomies were done between the 22nd-28th day of the menstrual cycle; hormonal therapy was begun between the 3rd-6th day. All but 1 of the group on combined preparations had anovulatory cycles. Detained follicles Grade 3 or 4 with precocious cystic atresic involution were observed. Of the 3 on the sequential preparation, 2 had involuted cystic corpora lutea and 1 had atresic follicles with thecal luteinization. The patients who received the injectable ovulated. There were no morphological or substantial changes in the corpora lutea of the control and IUD groups.^ieng