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At least 19 recordsLinked to original sources

Life-table methods for contraceptive research.

Life-table methods used for the analysis and interpretation of contraceptive follow-up studies differ from those used in other areas of medical research. The historical development of these methods in the contraceptive literature is outlined and the two main methods are discussed, compared and shown to differ mainly in their nomenclature; their results are very similar in practice. The daily life-table method is simpler to apply and interpret, and facilitates analysis using the logrank statistic as well as powerful regression modelling techniques for survival data.

Actuarial Analysis

Clinical experience with a new norgestimate-containing oral contraceptive.

Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.

Adult

Clinical experience with a new norgestimate-containing oral contraceptive.

Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.

Adult

Nonhormonal mediation of male reproductive tract damage: data from contraceptive drug research.

Chemicals can interfere with hormonal control of the male reproductive tract and/or directly alter male reproductive tract function. A review is presented of those chemicals developed and tested as male contraceptive agents which have a direct effect on the male reproductive tract with minimal disturbance of the hormonal milieu. Such chemicals can have one or more sites of action: 1) the testis, disturbing spermatogenesis; 2) the epididymis, altering sperm maturation; 3) the vas deferens, affecting sperm transport; and 4) the accessory sex glands, entering the ejaculate and changing the functional activity of the spermatozoa. Examples of each mode of action are presented.

Animals

Qualitative methods in operations research on contraceptive distribution systems: a case study from Nigeria.

This article discusses the application of qualitative methods in operations research on a family planning service delivery system. Market traders in Ibadan, Nigeria were trained to sell oral contraceptives, condoms, and spermicidal foaming tablets in a collaborative research project of the Fertility Research Unit of the University College Hospital, Ibadan, and the Center for Population and Family Health of Columbia University. Focus group discussion, participant observation, and semi-structured interviews were used to investigate the cultural acceptability of distribution of contraceptives in the market places and the motivations of participating traders. The strength of the market associations was a factor influencing acceptance of the project and the number of customers for the traders' other wares were found to positively influence the volume of sales of contraceptives. Traders were motivated by the status associated with participating in a program of a well-known health institution. Findings from qualitative research suggest areas for quantitative studies and vice versa in an interactive process.

Attitude to Health

Birth control methods in the United States.

U.S. women have fewer birth control options than do women in other developed countries. Reliance on sterilization helps many couples make up for their lack of choices, but high rates of sterilization among relatively young women are a cause for concern, given the chance of later regret. Although pill use is very high among young women, it falls dramatically among those in their 30s and, often unnecessarily, is minimal among those over 35. The IUD is most appropriate for older women in mutually monogamous relationships who have completed their families, and its availability has been limited in recent years because of liability problems. Although barrier methods are widely used by women of all ages, they are less effective than the pill or IUD. It is fair to conclude that given U.S. women's sometimes long intervals of exposure to the risk of unintended pregnancy, too few safe and effective reversible contraceptives are available in the United States. The addition of an acceptable new method would certainly lead to a reduction in unintended pregnancies, but many potentially useful new methods will not be developed in this century unless the amount of money invested in contraceptive research and development is substantially increased.

Acquired Immunodeficiency Syndrome

Patterns of research. Oral contraceptives and cervical cancer.

Original papers on the oral contraceptive use-cervical cancer relationship are analysed. The purpose of this study was to ascertain the biases of the original articles collected in relation to various characteristics of any investigation. Papers were located by using MEDLINE, reviewing the references of each article identified by MEDLINE, and then reviewing the contents of those journals in which an original could be published. Fifty-five publications (from 49 original studies) were graded as to quality and classified as biased or unbiased. Nineteen studies were considered unbiased. The most common biases identified were confounding, detection bias, and misclassification bias. The pattern of research/publication has changed since the association began to be analysed: articles shift from gynecological to cancer and epidemiological journals; the number of studies performed by gynecologists alone and pathologists alone decreases, while studies performed by epidemiologists alone or in collaboration with gynecologists increase. This collaboration produced studies with fewer biases. It is suggested that the above mentioned collaboration should be increased to improve access to, and then the application of the results obtained in the original studies on oral contraceptives and cervical cancer.

Bias

The next contraceptive revolution.

The availability of modern birth control methods has wrought a veritable contraceptive revolution in both developed and developing countries over the past two decades. But concerns about safety, costly lawsuits involving current methods, as well as diverse and changing life-styles, have left the current array of contraceptives grossly inadequate to meet growing world-wide needs. Steroid implants and improved injectables, IUDs, barrier methods and sterilization devices should be widely available in the next few years. But the long-sought-after radically new methods that will constitute the next contraceptive revolution--like vaccines, a male contraceptive and a once-a-month pill--will not be developed in the foreseeable future without a massive infusion of new funds. The eight contraceptive research and development (R&D) programs that are responsible for more than half of all current product development efforts now spend about $30 million a year on contraceptive research. With an additional $23 million annually, they could considerably accelerate current research efforts and begin new ones on products that have become possible only as the result of recent scientific discoveries. Even this level of investment--representing a 75 percent increase over current expenditures by the eight groups--would probably not be sufficient to make optimum progress in the development of radically new methods. Since the pharmaceutical industry can no longer be depended upon to take the leading role that it did 20 years ago, current public-sector R&D organizations may need to expand their efforts to include most aspects of the process of contraceptive development and introduction, and new dedicated R&D centers will probably have to be established.(ABSTRACT TRUNCATED AT 250 WORDS)

Contraception

The effect of gossypol on fast axonal transport and microtubule assembly.

Gossypol at micromolar concentrations (2 microM) was found to inhibit axonal transport and a microsomal ATPase activity in the frog sciatic nerve, although axonal microtubules and the neuronal content of AMP, ADP and ATP were not affected. At slightly higher concentrations (30-40 microM), gossypol also inhibited microtubule assembly and neuronal energy metabolism. Gossypol accumulated in the nerve and the results indicate that gossypol may act as a potent neurotoxin.

Adenosine Triphosphatases

Anti-fertility and other actions of gossypol analogues.

From a series of gossypol derivatives studied, we conclude that the carbonyl groups of gossypol are needed for inhibition of erythrocyte anion transport and the hydroxy groups affect but are not essential to that inhibition. In an in vitro mouse erythroleukemia cytocidal assay, the most active compounds were gossypol and apogossypol. The latter was not active in the inhibition of erythrocyte anion transport or in a spermicidal assay. Of the more simple structures related to gossypol, those that were active in the cytocidal and spermicidal assays were bi-aromatic, linked by a 1- and not a 4-carbon chain and had free phenolic hydroxyl groups. These results are included in a discussion of the specificity and mechanism of action of gossypol.

Animals