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Described are the various effects of birth control methods on the skin-mainly those of the contraceptive pill. The equilibrium of healthy skins and mucosa might be affected by these chemicals or pharmaceutical agents, causing different manifestations. The skin and mucosa should be looked upon as integral parts of the human body and its functions even where localized symptoms arise.
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Neo Sampoon is an effervescent contraceptive vaginal tablet manufactured in Japan that contains 60 mg of the spermicide menfegol. Ortho Vaginal Tablets (OVT) and Emko Vaginal Tablets (EVT), both containing 100 mg of the spermicide nonoxynol-9, were manufactured in the USA. The three products were compared in a randomized clinical trial conducted at the family planning clinics of the Korle-Bu Teaching Hospital and the Kotobaabi Polyclinic in Accra, Ghana. Three-hundred volunteers participated. At 12 months, the life-table pregnancy rates were 9.6, 11.3 and 12.5 per 100 women in the Neo Sampoon, OVT and EVT groups, respectively (p greater than 0.10). More EVT than Neo Sampoon or OVT users discontinued because of discomfort as well as for other product-related reasons (p less than 0.01). The most common reason for discontinuation was the temporary absence of sexual partner, with more than 40% of the women overall terminating for this reason. The 12-month life-table continuation rates per 100 women were higher for the Neo Sampoon group (62.4) than the OVT group (48.6) or the EVT group (38.5) (p less than 0.01). The effectiveness of the three products seems to be similar, but Neo Sampoon and OVT appear to be more acceptable than EVT in this Ghanaian population.
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All 25 strains of Candida spp. tested were able to grow in medium supplemented with 25% nonoxynol-9 in vitro. Adhesion of Candida spp. to HeLa cells was found to increase in the presence of 5% nonoxynol-9 (2.2- to 6.6-fold; P less than 0.001) and, to a lesser extent, in 12.5% nonoxynol-9. Adhesion of Candida strains cultured in medium supplemented with nonoxynol-9 varied, with five of six strains of Candida albicans and the single strain of Candida tropicalis demonstrating increases of 1.4 to 4.0 times control levels (P less than 0.05). The increased adhesion did not correlate with altered yeast cell surface hydrophobicity or germ tube formation.
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It has been suggested that the maternal use of spermicidal contraceptives increases the frequency of certain congenital anomalies, including trisomy, but this issue is in dispute. This controversy led us to examine whether the use of spermicidal contraceptives is associated with an increased risk of fetal trisomy. A questionnaire concerning contraceptive use was completed by 13,729 women who were undergoing prenatal fetal chromosome studies but were as yet unaware of the results. Most women were at increased risk of having a trisomic fetus because of their advanced age. Of 154 fetuses with trisomy, 98 had trisomy 21. For each woman (case) with an affected fetus, four controls were selected from among women with chromosomally normal fetuses, matched for maternal age and medical center. Cases and controls were compared by matched-sample maximum-likelihood logistic regression, to examine the association between fetal trisomy and four measures of spermicide use: periconceptional use, timing of last use, duration of last use, and total lifetime use. No evidence was found for an association, either when all types of trisomy were combined or when trisomy 21 alone was considered. All point estimates of odds ratios relating spermicidal exposure to trisomy were approximately 1, and an effect greater than a twofold increase was excluded with 95 percent confidence in the combined-trisomy group for all measures of spermicide use.
Several studies have found no increase in the overall frequency of birth defects in association with the use of spermicides, but the possibility of an increase in specific defects remains. We evaluated this possibility in a large case-control study. Infants with certain malformations (265 with Down's syndrome, 396 with hypospadias, 146 with limb reduction defects, 116 with neoplasms, and 215 with neural-tube defects) were compared with 3442 control infants with a wide variety of other defects. Exposure to spermicides was assessed for three periods: use during the periconceptional period (one month before through one month after the last menstrual period), use during the first trimester (the first four lunar months of pregnancy), and any use during the lifetime. For the five groups of cases and for each interval, the odds ratios were close to 1.0 (range, 0.7 to 1.3); the upper 95 percent confidence bounds were 2.2 or lower. Risks did not increase with the duration of exposure. When each of the active ingredients in currently available spermicides was considered separately, no differences in odds ratios were apparent between the types of spermicides. With the possible exception of a subgroup of cases (limb reduction defects of unknown cause), these results suggest that risks for the five specific birth defects evaluated are not increased by exposure to spermicides.
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The relation between periconceptional vaginal spermicide use and sex ratio at birth, birthweight, and the frequency of congenital anomalies was examined in a cohort of 2,712 New York City obstetric patients, 149 of whom (5.5 per cent) became pregnant while using spermicides or had used spermicides before and after conception. Periconceptional spermicide use was not associated with any important variation in the expected sex ratio at birth, nor with major or minor congenital anomalies. Exposure to spermicides in the periconceptional period, defined dichotomously as present or absent, was not associated with decreased birthweight in male or female infants. There was a slight decrease in birthweight among female infants with increasing duration of postconceptional spermicide use; an estimated 7.4 grams decrease with each day of use. The size of the effect and its selectivity by sex suggest a chance finding.
This study was a non-randomized clinical trial which compared the breast-feeding experience of 250 Argentine women taking levonorgestrel 0.03 mg daily (begun one week after delivery) with that of 250 women using non-hormonal contraceptives. Weight gain of unsupplemented infants, the most important of the several criteria used to assess breast-feeding performance, was similar for the two contraceptive groups. Levonorgestrel users began supplementary feeding of their infants significantly later than did non-hormonal users; levonorgestrel users were also somewhat less likely to discontinue breast-feeding during the study period. The two contraceptive groups were similar with regard to several other measures of breast-feeding performance: growth of all infants (regardless of supplementation), patterns of contraceptive discontinuation, mothers' subjective impressions of breast-milk sufficiency, and comparison of supplementation initiation with previous experience.
The clinical evaluation of drugs used in fertility regulation is initially assessed in Phase I, II and III trials. The design of each phase and the investigative staff must be adequate. In Phase I, normal, healthy human volunteers meeting specific guidelines are usually studied. Numbers vary between 20 and 80 and the purpose is to determine the acute toxicity of the compound. In Phase II, efficacy and safety are examined in a clinical target population, and emphasis may be placed on pharmacological and mechanistic studies. Usually between 50 and 200 patients are involved. In Phase III, large-scale clinical studies for local registration and the introduction of drugs to various countries are included. This paper describes the evaluation of various drugs used in contraception, including NORPLANT implants, and considers the efficiency, safety and acceptability of such drugs. Phase IV studies are usually needed to reveal chronic toxicities or rare events.
Gossypol has been used as oral contraceptive for man in People's Republic of China. There are also some reports of studies in which gossypol acetic acid is used in animal experiments. In this study we used tablet preparation of gossypol, which is actually used as oral contraceptive for male in People's Republic of China, on a volunteer. The administration of 20 mg/day gossypol tablets for 19 days resulted in a tendency of decreasing sperm density and total sperm count, but had no effect on serum LH, FSH, PRL or testosterone. Furthermore, the volunteer had no complaints of side effects and his general laboratory findings were normal. Ten days after the termination of gossypol administration, sperm density returned to its preadministrative level. Our study suggests gossypol may be effective as a male oral contraceptive with no acute side effect.
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The radioisotopic method of 131J-labelled albumin was employed to determine the distribution of acidic proteinase activity in some organs and tissues of chickens. The highest enzymatic activities were found in intestine wall, in pancreas, and in liver. Considerably lower activities were ascertained in kidneys, brain, lungs, and heart. The different proportions of these enzymes in homogenates and supernatant fractions (106 000 g) testify to a lack of uniformity in the solubility of cathepsins in the organs tested. The tested organs, with the exception of pancreas, did not show any enzymatic activity of neutral proteinases.