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testosterone treatment 34 articles

Antares seeks FDA approval for QuickShot Testosterone auto-injector

Antares Pharma is the latest pharmaceutical company hoping to profit off the booming testosterone replacement therapy market. The company announced it has submitted an application to the Food and Drug Administration (FDA) for marketing approval for its QuickShot Testosterone therapy designed to boost levels of the hormone in men. QuickShot Testosterone is a drug-device combo that delivers testosterone enanthate through a subcutaneous auto-injector that can be self-administered. It’s also touted to be less painful than intramuscular injections. It uses high spring pressure to deliver the drug through a fine gauge needle. Antares says the delivery system essentially eliminates the risk of ... Read More

AndroGel makers tried to persuade doctors to widen use of testosterone

AbbVie Inc., maker of the blockbuster testosterone treatment AndroGel, offered free education courses to doctors for continuing medical education credits (CME), which are required for doctors to keep their medical licenses, a Milwaukee Journal Sentinel/MedPage Today investigation has found. The classes promoted unapproved uses for the hormone treatment. Testosterone treatments are approved by the Food and Drug Administration (FDA) to treat hypogonadism, a condition in which the body does not produce enough testosterone due to disease or injury. The condition can cause fertility issues, low libido and muscle loss. In recent years, manufacturers of testosterone treatments have launched aggressive advertising ... Read More

First-time users of testosterone replacement treatments are at greater risk of heart attack

Men using testosterone replacement treatments are at greater risk of suffering a heart attack during the first 90 days of treatment than men who have been on the hormone replacement for more than four months. They were also at greater risk of heart attack compared to men who had used the treatment and discontinued use, according to a new study published in the journal Pharmacotherapy. The study involved data from the IMS LikeLink database for new-onset heart attacks in men ages 45 to 80 who had filled at least one prescription for testosterone replacement therapy. Researchers looked at current users ... Read More

Educational ‘Low T’ website leaves out information about testosterone side effects

AbbVie, maker of the testosterone treatment Androgel, wants to help men determine if they are “one of the millions of men who have Low T,” so they put together an online questionnaire as a guide. Do you have a decrease in libido (sex drive)? Lack of energy? Decrease in strength and/or endurance? Have you lost height? Noticed a recent deterioration in your ability to play sports? Fall asleep after dinner? Has there been a recent deterioration in your work performance? A decrease in your enjoyment of life? Are your erections less strong? Are you sad and/or grumpy? Men who answer ... Read More

Abbott, AbbVie face varying lawsuits with AndroGel

Abbott Laboratories and AbbVie skirted racketeering claims alleging the companies made health plans pay unnecessarily for the arthritis drug Humira and the testosterone replacement AndroGel instead of less expensive generics. U.S. District Judge Robert Dow said plaintiffs New England Carpenters Health and Welfare Fund failed to show that the defendants teamed up with pharmacies and intermediaries to illegally increase sales of the drugs by offering savings cards or coupons to reduce copayments. The fund also accused Abbott and AbbVie of insurance fraud, alleging the companies instructed pharmacies to hid subsidies by processing them as secondary insurance rather than discounts. “While ... Read More

Lawsuit filed against Pfizer related to testosterone replacement drug

Pfizer’s testosterone replacement treatment Depo-Testosterone has become the subject of lawsuits questioning the safety and efficacy of the drugs after reports of heart attacks, strokes and blood clots in patients treated with the hormone. The lawsuit filed on behalf of Alvaro Roman Gutierrez alleges that Pfizer and its unit Pharmacia & Upjohn Co. LLC, conducted a “disease mongering” campaign to exaggerate the problem of low testosterone levels in men in order to boost sales of Depo-Testosterone. Gutierrez claims that Pfizer and Pharmacia & Upjohn spent millions of dollars to promote its drug to consumers and, along with other drug companies not ... Read More

Experimental testosterone therapy outperforms leading testosterone gel in studies

The experimental testosterone treatment Androxal performed better than a leading testosterone gel and placebo in the first of two studies, Repros Therapeutics Inc. announced. Data from the clinical trials showed that men treated with Androxal had more sperm concentration compared to men who were treated with AndroGel testosterone supplement. Androxal is being developed as an oral therapy to boost testosterone levels in men of reproductive age. Androxal a single isomer of clomiphene citrate, a drug currently marketed as Clomid to induce ovulation in women. It has been used off-label as a treatment for secondary low testosterone in men though, until ... Read More

New testosterone treatment in development carries fewer side effects

Testosterone levels in men typically drop as a man ages, but when it drops too low it signals a possible problem. In many cases the drop can be associated with obesity, diabetes and circulatory disease. Low testosterone levels can result in symptoms such as low libido, loss of muscle mass, increased body fat, and depression. Regardless the cause, many doctors prescribe testosterone replacement therapies, such as AndroGel, Axiron and Testim, to treat the condition. However, recent studies have shown that testosterone therapy can increase the risk of heart attack, stroke or death. The drugs can also be expensive, and after ... Read More

Drug company tests new drug to boost testosterone levels in men

A new treatment designed to boost testosterone levels in men, which is not a testosterone replacement therapy, is currently being tested in clinical trials. If data is favorable, the drug could be considered for regulatory approval by the end of the year. Repros Therapeutics’ Androxal is a single isomer of clomiphene citrate, which is widely prescribed under the brand name Clomid to induce ovulation in women. The drug has been used off-label as a treatment of secondary male hypogonadism, a condition of low testosterone. Repros is developing Androxal for men of reproductive age with low testosterone due to secondary hypogonadism. ... Read More

Testosterone levels tend to fluctuate significantly in younger men but remain more constant in older men

Most schools of thought suggest that measuring testosterone levels in men can be tricky because the hormone levels vary from day to day as well as hour to hour. However, a new study finds that only young men experience statistically and clinically significant fluctuations in testosterone levels. Researchers studied records of more than 2,500 men ages 26 to 84 who had their testosterone levels checked at an erectile dysfunction clinic. The men were sorted into five age groups, beginning with 26- to 39-year-olds. Each of those groups were divided into sub-groups depending on the time of day their testosterone was ... Read More