WASHINGTON ( ABC7 ) It’s a problem men don’t want to talk about. And that may be why some are vulnerable to quick fix pitches to treat erectile dysfunction. The 7 ON YOUR SIDE I-Team found thousands of men have paid top dollar at clinics around the country. But many say the company’s tactics don’t work. Low Testosterone levels is not a common cause of Erectile Dysfunction but in cases where inadequate production or testosterone does lead to ED, testosterone replacement therapy can be effective. More often Low Testosterone is a contributing factor and is better used in conjunction with a more direct treatment for ED. For many men, TRT can also be valuable in improving their sex drive which helps in achieving and maintaining erections.
Fildena inhibits an enzyme called phosphodiesterase-5 (PDE5) which destroys the cGMP. Thus, Fildena prevents the destruction of cGMP and allows cGMP to accumulate and persist longer. The longer cGMP persists, the more prolonged the engorgement of the penis. The FDA approved Fildena in March 1998.
Levothyroxine as an API is unstable, and the FDA recently tightened manufacturing standards for all versions There are no well-documented cases of therapeutic inequivalence between brands deemed to be bioequivalent. Most health professionals still recommend using a consistent brand, however.
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Ironically, even if a generic drug turns out to have a problem, current rules prevent the manufacturers from alerting physicians or patients. There’s a rule that requires generic drug manufacturers to include an exact copy of the package insert that’s included with the innovator drug. While this rule was intended to reflect the idea that the drugs are bioequivalent, the unintended side effect has been to avoid placing the same diligence requirements and burden of ensuring safety on the generic manufacturers that we require from branded manufacturers.
The next step in bringing a new medicine to market is the filing of an application with the health regulatory authority of a country in order to obtain approval to market the new medicine. This step is known as registration. In the US, a New Drug Application (NDA) or Biologic Licence Application (BLA) is filed with the US Food and Drug Administration (FDA). In Europe, a Marketing Authorization Application (MAA) is filed with the European Medicines Agency (EMA), or local competent authority, dependent on the approval route being used. A description of the medicine’s manufacturing process along with quality data and trial results are provided to the health regulatory authorities in order to demonstrate the safety and effectiveness of the new medicine. If approval is granted, the new medicine can be marketed for use by patients.
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There are two main causes of ED: physical and psychological. Most doctors agree that the majority of cases are physical but it’s also clear that many men with ED also quickly start to feel anxious, stressed or depressed. These feelings can easily make the symptoms of ED worse.
Choosing a birth control method can be daunting, but if you have settled on using the pill to prevent unwanted pregnancy, arm yourself with information. Oral contraceptives offer a range of options that can make selecting one a little easier. Creating a list of birth control pills with your doctor’s guidance can make the choice simple and help you make the best decision for you.
The first evidence that oral supplementation with arginine leads to improvement in human sexual function came from a short-term study in 1994, which employed few patients and relied on patient self-assessment.5 Though encouraging, it provided little solid data. It did, however, yield a positive correlation between arginine supplementation and sexual performance and satisfaction.
Empirical sexological work also contributed to this shift toward objective” science. Zoologist Alfred Kinsey’s Sexual Behavior in the Human Male (1948), an encyclopedic study of over 6000 American men’s self-reported sexual behaviors and experiences, played a pivotal role in the shift from analytic to biomedical understandings of sexuality. While Kinsey stated that his work would be useful to physicians, psychiatrists, and psychoanalysts alike, his understanding of sexuality as a concrete and quantifiable entity engendered a new type of scientific approach to the topic. Kinsey’s claim to present data about sex which would represent an accumulation of scientific fact completely divorced from questions of moral value and social custom” (1948:3) engendered the notion that sex could be understood as an objective entity disconnected from mind or culture.