Background: Menstrual cups have been available for decades, but their use is limited by bulky design and the need for multiple sizes. The Softcup Ò (Instead, Inc., San Diego, CA) is a simple single-size disposable over-thecounter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during coitus. This report describes preclinical evaluation, clinical testing, and postmarketing monitoring of the Softcup. Methods: Preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Postmarketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system. Results: No toxicity or mutagenicity was observed in preclinical evaluations. In clinical testing, after three cycles of cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons. The cup was preferred for comfort, dryness, and less odor. Cups received lower ratings for disposal and convenience. Eighty-one percent of enrolled women were able to insert and remove their first cup using only written instructions. Use difficulties resulting in study discontinuations included cramping (1%), leakage (1%), and improper fit (3%). No safety parameters were adversely affected. No significant health risks were reported during postmarketing surveillance.Conclusions: These results demonstrate that a single-size vaginal device has no significant health risks and is acceptable to many women without the need for fitting or other medical services.
A new reagent, fluorescamine, provides a simple, rapid fluorometric measurement of primary amino compounds in seawater.The reagent detects as little as 0.2 r.lM (glycine equivalents) directly in 2 ml of seawater.
Axenic cultures of 25 species of unicellular marine algae were tested for their ability to utilize nine common amino acids, supplied at high concentrations in batch culture, as a nitrogen source; most species were able to use several amino acids, although growth was often slower than on nitrate nitrogen.The algae were also tested for their ability to t,ake up '"C-labclcd amino acids supplied at low, natural concentrations. In most cases, species that could grow on an amino acid at high concentration in culture could also take up amino acids at low concentrations.Uptake rates were higher in cells that had been deprived of nitrogen during growth.In some cases, uptake rates at low concentrations-if sustained-would bc sufficient to support moderate growth rates. The ability to accumulate amino acids from dilute solution occurs in many phytoplankters, particularly in spccics that normally occur in inshore and littoral habitats.
Uptake of [14C]glycine by various size fractions of natural plankton communities was measured to determine if phytoplankton can compete effectively with other members of the plankton community for the free amino acids in seawater. The simultaneous occurrence of glycine uptake, plant pigments, and photosynthetic activity in the same size fractions, as well as autoradiography of the plankton samples, indicated that in some cases phytoplankton were responsible for 50% or more of glycine uptake. Comparison of prefiltration and postfiltration procedures for this type of study provided an explanation for the discrepancy between these results and those of previous studies.
Many algae, including some marine phytoplankters, behave heterotrophically in laboratory culture. Organic compounds have been systematically employed in algal culture since 1905 (Treboux). Glucose, pyruvate, and acetate commonly support or augment growth. Amino acids may serve as acceptable nitrogen sources in culture (
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