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At least 271 records · Page 15Linked to original sources

Steroids and "the pill": early steroid research at Searle.

The announcement from the Mayo Clinic in 1949 of the dramatic effectiveness of cortisone in the treatment of rheumatoid arthritis stimulated tremendous interest in steroid chemistry, endocrinology, and related areas of medicine. Shortly thereafter, G. D. Searle & Co. initiated a major effort in steroid research, the objective of which was to discover better steroid drugs than those available at that time or steroids that could be used for conditions for which no compounds were previously available. This effort was remarkably successful and resulted in the introduction of several important pioneering drugs. These included norethandrolone, marketed in 1956 as Nilevar, the first anabolic agent with a favorable separation between protein building and virilization, and spironolactone, introduced in 1959 as Aldactone, the first steroid antialdosterone antihypertensive agent. Of special importance was the research that culminated in the discovery of Enovid. This substance, a combination of the progestin norethynodrel and the estrogen mestranol was first approved in 1957 for the treatment of a variety of disorders associated with the menstrual cycle. The era of oral contraception began in May 1960, when Enovid was approved by the Food and Drug Administration for ovulation inhibition, and was immediately thereafter introduced for such use.

Contraceptives, Oral, Hormonal↗

Comparative study on the efficacy, acceptability, and side effects of a contraceptive pill administered by the oral and the vaginal route: an international multicenter clinical trial.

The objective of this multicenter randomized clinical trial was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. Eight hundred nineteen healthy, parous women of reproductive age were recruited at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. These women were randomly assigned to use either oral or vaginal administration of the same contraceptive pill, which contained 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol. No statistically significant differences were found in discontinuation rates between the two groups after 1 year. Involuntary pregnancy rates after 1 year were not statistically significantly different between the two groups. The vaginal route of administration appears to be as acceptable and efficacious as the oral route.

Administration, Intravaginal↗

Vitamin B6 nutriture during pregnancy and lactation. II. The effect of long-term use of oral contraceptives.

Vitamin B6 nutriture was assessed during pregnancy and lactation to determine whether previous use of oral contraceptive agents (OCA) resulted in reduced reserves of the vitamin. Vitamin B6 levels were measured in maternal serum and urine at 5 and 7 months gestation and at delivery, in cord serum and in milk at 3 and 14 days postpartum. Long-term use of OCA (greater than 30 months) resulted in low levels of vitamin B6 in maternal serum at 5 months gestation and at delivery and in milk compared with values for short-term (1 to 30 months) and nonusers of OCA. Levels of vitamin B6 were also lower in the cord serum of long-term users of OCA as compared to nonusers.

Adolescent↗

Acceptability of a novel vaginal microbicide during a safety trial among low-risk women.

CONTEXT: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users. METHODS: A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews. RESULTS: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel. Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection. CONCLUSIONS: Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.

Administration, Intravaginal↗

[Changes in the contraceptive method mix during fertility decline: Latin America and the Caribbean].

"This paper reviews survey-based data regarding contraceptive prevalence and methods employed in Latin America and the Caribbean, with an emphasis on changes in the mix of methods over time. The most striking recent trend is the rise in use of female sterilization.... By contrast, use of male sterilization remains negligible in most countries. The oral contraceptive pill is by far the most popular of the temporary methods, though its prevalence has more often declined than increased in recent years. Together female sterilization and the pill make up around [two-thirds] of contraceptive practice in Latin America and the Caribbean." (SUMMARY IN ENG)

Americas↗