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PubMed1989

Monthly injectable steroid contraceptives and cervical carcinoma.

The World Health Organization Collaborative Study of Neoplasia and Steroid Contraceptives is a large multinational hospital-based case-control study of steroid contraceptives and gynecologic, hepatobiliary, and mammary neoplasms. Monthly injectable steroid contraceptives which contained the long-acting progestogen dihydroxyprogesterone acetofenide plus a shorter-acting estrogen (usually estradiol enanthate) were used by women in two of the countries (Chile and Mexico) from which data were collected. In preliminary analyses of data from Chile (1979-1983), a strong association was observed between use of these products and invasive cervical cancer. Therefore, three additional data sets from these two countries were analyzed in further detail for this report. Analyses of additional data from Chile on invasive cervical cancer (1983-1985) and cervical carcinoma in situ (1979-1986) and of data on invasive cervical cancer from Mexico (1979-1986) failed to confirm the initially observed association. The original finding was probably due to chance, but a causal interpretation cannot be confidently ruled out, and additional studies are warranted.

Algestone Acetophenide↗
PubMedDate not supplied

Histometric and cytochitechral studies on the rat testis following combined administration of testosterone enanthate and ethinyl estradiol.

Combined administration of TE & EE for 72 days inhibited spermatogenesis. Testicular weight along with germinal height and tubular diameter decreased. Pachytene spermatocytes started becoming pycnotic and less in number by 24 days treatment. Almost no spermatozoa were seen in the lumen by 36 days and very few secondary spermatocytes and spermatids by 60 days. Marked disorganisation and desquamation was observed by the end of treatment. Leydig cells were also atrophied. Increase in swollen cell bodies, vacuolization, karyiolysis, pycnosis and cytolysis were observed after 72 days of treatment. Almost full recovery after 30 days of cessation of treatment was noticed.

Animals↗
PubMed1991

A multicentred, two-year, phase III clinical trial of norethisterone enanthate 50 mg plus estradiol valerate 5 mg as a monthly injectable contraceptive.

Norethisterone enanthate (NET-EN) 50 mg combined with estradiol valerate (EV) 5 mg was studied as a once-a-month injectable contraceptive with regard to effectiveness, cycle control, adverse events and acceptability. In eight Family Planning Centres from 5 Latin American countries, 652 fertile women were followed-up for a period of 24 months, providing a total of 10,689 woman-months of experience. Only 1 pregnancy occurred, in the first treated month a few days before the second injection (failure rate 0.11 per 100 woman-years). Under treatment, the first cycle was drastically shortened in most cases, but thereafter cycles tended to recover to pre-treatment patterns. There was a significant decrease of hypermenorrhea and dysmenorrheic cycles. Intracyclic bleeding and spotting appeared in 1.2% and 2.4%, respectively, and amenorrhea in 2.5% of cycles. Incidence of other adverse events was very low with the exception of weight gain of 2 Kg (28%). Continuation rate at 12 months was 64.7%. The cumulative discontinuation rate due to bleeding problems was 7.4% and 10.7% due to adverse events at 24 months.

Adolescent↗
PubMed1994

Multicentred, phase III clinical trial of norethisterone enanthate 50 mg plus estradiol valerate 5 mg as a monthly injectable contraceptive; final three-year report.

Norethisterone enanthate (NET-EN) 50 mg combined with estradiol valerate (EV) 5 mg was studied as a once-a-month injectable contraceptive with regard to effectiveness, cycle control, adverse events and acceptability. In eight Family Planning Centres from five Latin American countries, 931 fertile women were followed-up for a period of 36 months, providing a total of 15,787 woman-months of experience. Only one pregnancy occurred: in the first treated month a few days before the second injection (failure rate 0.08 per 100 woman-years). Under treatment, the first cycle was drastically shortened in most cases, but thereafter cycles tended to recover to pre-treatment patterns. There was a significant decrease of hypermenorrhoea and dysmenorrheic cycles. Intracyclic bleeding and spotting appeared in 1.8% and 2.2%, respectively, and amenorrhea in 2.8% of cycles. The incidence of other adverse events was very low with the exception of weight gain of more than 2 kg (36.8%). The continuation rate at 12 months was 64.7%, at 24 months 31.0% and at 36 months 20.4%. The cumulative discontinuation rate due to bleeding problems was 6.1% and 7.2% due to adverse events at 36 months. The treatment was shown to be a highly effective contraceptive method that offers fairly good cycle control, good tolerance and a continuation rate that makes it suitable for use in family planning programmes in the Latin American area.

Amenorrhea↗
PubMed1989

Long-acting estrogenic responses of estradiol fatty acid esters.

Estradiol esters at C-17 and C-3 with palmitic, stearic and oleic acids were chemically synthesized and then evaluated for their long-acting estrogenic responses in ovariectomized rats. The duration of the biological effects was measured after a single subcutaneous dose of 0.1 mumol of each ester and compared with those observed with 17 beta-estradiol, estradiol 3-benzoate and estradiol 17-enanthate. Vaginal citology, uterophyc action, serum gonadotropins inhibition and 17 beta-estradiol levels were measured 0, 5, 10, 20, 30 and 60 days after injection. The results disclosed that most of the estradiol derivatives evaluated exhibited a long-acting estrogenic action. However, the monoesters at C-17 showed longer effects that monoesters at C-3, while the estradiol diesters exhibited the shortest effects. In addition as shown by its low serum levels, all estradiol esters with unsaturated fatty acids show a decreased E2 absorption. The overall results indicated that esterification of E2 with long chain fatty acids provided long-acting properties to it, being higher with C-17 esters. Whether some of these compounds could be employed in substitutive endocrine therapy remains to be established.

Animals↗
PubMed1983

Maintenance of sexual function in a castrated man treated with ovarian steroids.

Sexual function, mood states, and endocrine levels were studied in a 48-year-old man who had been castrated bilaterally because of severe post-vasectomy orchialgia and who habitually uses oral estrogen and progestin. He reported satisfactory sexual behavior with a usual coital frequency of at least twice per week while on treatment with Premarin and Provera. Though his nocturnal penile tumescence (recorded on a portable home monitor) was very low while on this treatment, psychophysiological tests showed that erectile responses to erotic film were well within the normal range for control subjects in this laboratory. A double-blind experiment was performed to assess his sexual functioning and mood states during treatment with placebo, testosterone enanthate, and estradiol valerate, with and without progesterone (one injection of each, with 4-week intervals between treatments). All treatments generated prolonged changes in circulating hormone levels; testosterone treatment was associated with elevated estradiol levels, and estradiol with massively increased plasma prolactin. Coital frequency was highest with the estrogen-progestin treatment and lowest with placebo. Testosterone precipitated a very high frequency of spontaneous erections and severe negative affect. The subject also reported low sexual drive and poor mood states while taking Provera alone. It was concluded that the preferred estrogen-progestin treatment of this patient, probably in conjunction with minimal androgen levels from his adrenal, are most likely responsible for maintaining his satisfactory sexual functioning. There is no evidence that other castrates would necessarily benefit from a similar hormonal regimen.

Castration↗
PubMed1991

Long-acting hormonal contraceptives for women.

Following the development and widespread use of oral hormonal contraceptives, it became evident that alternative long-acting delivery systems would be required to improve contraceptive practice in some cultural settings where injectable or subdermal routes of administration are preferred. Nowadays, long-acting contraceptives constitute an important option in family planning services in many parts of the world. Indeed, two long-acting injectable contraceptives containing just a synthetic progestogen (depot-medroxyprogesterone acetate (DMPA) and norethisterone enantate (NET-EN)) have been in clinical practice for more than 20 years. The World Health Organization's (WHO) Special Programme of Research in Human Reproduction, in collaboration with the U.S. National Institute of Child Health and Human Development (NICHD) and universities primarily in developing countries undertook a synthesis programme aimed at producing an improved injectable preparation by developing new derivatives of known steroids. One such compound (levonorgestrel 17-butanoate) is now at the stage of Phase II clinical testing. In addition, the Special Programme has developed and improved once-a-month injectable formulations and assessed their safety and efficacy in different countries worldwide. After large scale clinical testing, at least two progestogen-estrogen combinations have reached the point of introductory trials.

Aniline Compounds↗
PubMed1980

Lactation suppression.

In spite of a very recent upsurge in breast-feeding in industrialized countries, approximately one-half of parturients are candidates for postpartum lactation suppression. The mechanisms controlling lactation are complex and involve preparation of the breast during pregnancy, stimulation of secretion of milk in the immediate postpartum period, ejection of milk from the alveolar cells, and maintenance of milk production during the period od lactation. The local effects of estrogen and progesterone in the breast prevent milk secretion during pregnancy. With their withdrawal in the postpartum period, the stimulating effect of the anterior pituitary hormone prolactin dominates and milk secretion is initiated and maintained. Milk ejection is accomplished by a neurohormonal reflex resulting in stimulation of the myoepithelial cells of the breast by the posterior pituitary hormone oxytocin. Local stimulation of the breast by suckling is important in initiating the release of oxytocin and also the secretion of prolactin. The suppression of lactation in the postpartum period can be accomplished in approximately 60--70% of females by the use of a tight brassiere and avoidance of stimulation of the nipples. An additional 10% or so of females can be helped with the use of estrogens during the postpartum period. The addition of an androgen to the estrogen increases the success rate of lactation suppression to about 90%. Unfortunately, the use of estrogen alone or in combination with an androgen is accompanied by rebound lactation in a significant number of patients and has been associated with an increased incidence of postpartum thromboembolic disease. Lactation suppression by inhibiting prolactin secretion with synthetic ergot alkaloids such as bromocriptine has been shown to be safe and highly effective both immediately post partum and after lactation has been established. The 2 week period of therapy required with this drug may be unsatisfactory for some patients. If given immediately at delivery, a single injection of testosterone enanthate and estradiol valerate is equally effective in suppressing lactation and, in the young patient who has delivered vaginally, is not associated with significant risk.

Androgens↗