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The US Food and Drug Administration (FDA) has approved testosterone undecanoate (Jatenzo) for the treatment of men with hypogonadism. The oral capsule therapy is designated for men with low testosterone levels due to specific genetic disorders or pituitary gland-damaging tumors.

However, the FDA approval does not designate undecanoate for age-related hypogonadism—in which men’s testosterone levels are in decline due to aging—due to the therapy’s benefits not outweighing its risks in that use.Testosterone decanoate powder

The efficacy of Jatenzo, from Clarus Therapeutics, was demonstrated in a four-month clinical trial in which a 237 mg oral drug was administered twice daily to 166 men with hypogonadism. Patient doses were adjusted either downward or upward to a maximum of 396 mg twice daily based on current testosterone levels.

Investigators reported that 87% of therapy-treated men achieved the primary endpoint of an average normal-range testosterone level. Common adverse effects, which occurred in at least 2% of patients in the trial included headache, red blood cell count increases, decreases in high-density lipoprotein cholesterol, high blood pressure, and nausea.

Testosterone undecanoate’s label will be marketed with a boxed warning stating it can cause risen blood pressure, thereby increasing heart attack, stroke, and cardiovascular death risks. Physicians are advised to periodically monitor their patients’ blood pressure during treatment.

With the approval, testosterone undecanoate becomes the second testosterone product to carry that warning. The FDA requires all testosterone product manufacturers to perform post-marketing blood pressure trials to better address the products’ risks.

Hylton V. Joffe, MD, MMSc, director of the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, said that testosterone undecanoate’s oral administration makes it an “important addition to current treatment options available” for the patient population. Up until now, most testosterone products are administered subcutaneously or intravenously.

“But it’s important to emphasize that this drug should not, like other testosterone treatments, be used to treat older men with ‘age-related hypogonadism’,” Joffe said in a statement. “The benefits of testosterone therapy, including Jatenzo, have not been established for this use, and Jatenzo’s effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population.”

Some aging men might have perked up at the news that the U.S. Food and Drug Administration (FDA) approved an oral testosterone treatment for hypogonadism, or low gonadal testosterone production. After all, with advertisements bombarding them with claims that attribute all of their ills to “low T” and urge them to “ask their doctor” about it, aging men might think it’s high time for a pill to pop instead of dealing with a messy gel.Testosterone decanoate benefits

Unfortunately for them, the agency says that the newly approved drug, Jatenzo (testosterone undecanoate; Clarus Therapeutics) isn’t for age-related testosterone declines. Instead, it’s intended to treat people who have hypogonadism because of less common causes, such as tumors of the pituitary gland or Klinefelter’s syndrome. This form of testosterone was previously approved as an injectable, Aveed (Pfizer).

The pituitary gland sends messages to the gonads that regulate release of hormones, and tumors can turn the volume on these messages inappropriately up or down . Klinefelter’s syndrome is the name given to the suite of traits that result when someone carries a Y chromosome along with two X chromosomes. One of the features of Klinefelter’s can be smaller-than-average testes that produce low levels of testosterone. Having this condition is associated with increased risks for obesity, insulin resistance and mortality, which is related to why the FDA views the benefits of Jatenzo as outweighing risks for this population.
The drawback of Jatenzo, the FDA said in a statement, is that as with all testosterone treatments, risks increase for higher blood pressure, which in turn is a risk for cardiovascular disease and death. For people who have pituitary tumors or Klinefelter’s syndrome, it’s possible that the benefits of the drug outweigh these risks. For older men experiencing typical effects of aging, however, it is not, the FDA concluded. About a third of men in older age might have hypogonadism.

The cardiovascular risk is sufficient that the drug label will carry a boxed warning, as does Aveed, which is available only through the FDA’s tightly controlled risk evaluation and mitigation strategy. The agency urges that clinicians keep each individual patient’s cardiovascular risk in mind and ensure that their blood pressure controlled when on the drug. People with the conditions that are considered indications for taking Jatenzo often are already using some other form of testosterone (injection or skin patch), so their risk may not vary with a switch to an oral pill. Almost 9 out of 10 of the 166 participants in the 4-month trial of Jatenzo saw their testosterone levels rise to normal range while taking the drug.

There is a new option for treating testosterone deficiency in adult men. I know, there are already gels, patches, injections and adhesive patches you stick on your gums (Striant) but apparently, we need one more and . . . wait for it . . . it’s a nasal gel. Natesto is the first nasal testosterone gel approved in the United States for the treatment of male hypogonadism and testosterone deficiency. Natesto is a metered-dose pump applicator that places the gel into the nostrils.

Advantages? Because this gel is applied inside of the nostril, there is little chance of transferring testosterone to women or children who come into close physical contact with the person using the intranasal gel. That can occur with the gels and patches used on the skin.Testosterone decanoate Uses

Disadvantages? Some men won’t like that it needs to be used three times daily. People with allergies or underlying nasal or sinus problems also may not like Natesto as a runny nose, sore throat and sinusitis are among the most common side effects.

What’s the dosage? One pump delivers 5.5 mg of testosterone so the recommended dose is 11 mg (two pumps, one in each nostril), three times a day.

Should you try Natesto now? Most physicians think until further data are available, that using the older tried and true methods are still the way to go. A worrisome point is that data in mice show brain levels of testosterone that are twice as high with the nasal gel as with intravenous testosterone. We don’t know if this occurs in men treated with the nasal gel, but maybe stick to the available testosterone gels, patch, or injections.

Footballers from around the globe are slowly making their way back to training this week which can only mean one thing. The new season, and the new version of FIFA 20 is closer than ever. Whether you're going to tiki-taka your way to glory with Dortmund, long ball your way out of the relegation zone with Newcastle or hit and hope with Arsenal - you'll be able to get your practice in soon with the new FIFA 20 demo. Here's everything we know so far:fifacoinsbuy

Based on previous release dates, there should be a demo two weeks before full release - meaning 12th September 2019 is the most likely date that you can play FIFA 20 on Xbox One, Playstation 4 and PC.

Unfortunately nothing new was shown about Career Mode and Ultimate Team at E3. They're definitely still a thing though. We're hoping to get some big improvements but we'll have to wait and see.

Usually, the demo only lets you use a select few teams. At the moment, EA haven't confirmed which teams will be usable. The latest trailer features Manchester United, Paris Saint-Germain, Bayern Munch and Juventus, so that could be a sign that those are the ones to feature.

Barcelona, Liverpool and Arsenal, have licensing deals with their rivals, Pro Evolution Soccer so we can assume they won't feature.

There's a brand new mode called 'VOLTA'. EA describe it as: "a brand-new style of gameplay grounded in football realism which immerses players in the flow of the street with new tools including simplified flicks and skill moves, new flair animations, or using the wall as a teammate."fut coins online Buy Now

EA Sports revealed that it has ended its partnership with Juventus Football Club. The partnership officially ends June 30, which means Juventus is no longer part of fifa 20 coins for sale.

In other sports games this may have been a minor occurrence, but that isn't the case here. Fans of the game, and even the sport, know that this announcement is rather huge. Why you ask? Well Juventus has on its roster a certain player by the name of Cristiano Ronaldo. Yes, that Ronaldo.

What happened? Juventus appeared to have signed an exclusive deal with Pro Evolution Soccer 2020. This is not the first time that EA and PES have butted heads when it came to getting exclusive deals from football clubs. EA has been able to grab the license to almost every team and player. One notable absence was back in FIFA 99, when EA was unable to get Ronaldo (de Lima). PES has relied mainly on its gameplay instead of having to pay for expensive licenses. This marks the first time PES managed to get ahead of EA.So what happens now? In the past when PES failed to get Juventus, it came up with a team known as PM Black White. This time it's EA's turn. Instead of Juventus, FIFA 20 now has Piemonte Calcio which:

Is a new playable team in FIFA 20 with a custom badge and kit throughout Kick-Off, Career Mode, and EA SPORTS VOLTA Football.
Piemonte Calcio remains to be a playable team within Career Mode in FIFA 20, featuring authentic players and up-to-date player ratings.
Uses real-world, authentic players in FIFA 20 and FIFA 20 Ultimate Team.
What this means is that Piemonte Calcio players are not going to have any generic names or generic faces.
It also means that the squad’s player ratings are going to be updated based off of their real-world performances.
In addition, Piemonte Calcio players continue to be eligible for Special Items
Has players' Chemistry within FIFA 20 Ultimate Team unaffected by the changes.
EA also said that these changes are not going to affect any of the previous FIFA titles. FIFA 20 is scheduled to be released this September.Click to Buy more fut coins

The madden 20 coins release date is August 2 and, at E3 2019 today, we learned about the fact that it's debuting fresh modes, player-exclusive moves, and bringing back old favorites game types like Pro Bowl, according new details revealed by EA Sports.

Technically, you won't have to wait for the official August 2 release date to play this game. Madden 20 early access begins July 31, and you can get on the field even earlier with the Madden NFL 20 closed beta – that runs a single weekend, from June 14 to June 16, according to EA. In this close beta, however, your progress will reset to give every a fair chance at launch.

Face of the Franchise is the big highlight to Madden for 2020. For the first time, you can create and develop your own quarterback who goes from of one of ten D1 schools to the road to the next NFL superstar. Scenario Engine brings dynamic challenges to games to improve your player's stats along the way.

X-Factor abilities are the reason you'll still want to play as real-life superstar players. For example, Kansas City Chiefs QB Patrick Mahomes is the Madden NFL 2020 cover athlete and he has the exclusive Bazooka Superstar X-Factor ability. It stretches his normal reach by 15 or more yards when he's in this special zone. This is on top of normal Superstar moves of Escape Artist, Dashing Dead eye, Red Zone Deadeye.

Madden NFL 20 X-Factor abilities branch out beyond quarterbacks, too. Los Angeles Rams defensive tackle Aaron Donald has an X-Factor move called Fearmonger, and it's designed to intimidate and overcome blockers when he's in the zone. New Orleans Saints wide receiver Alvin Kamara has a zone-enabled 'Satellite' X-Factor that allows him to perform better in key one-on-one situations.
Pro Bowl is back in this year's football game, and it's been expanded to include these new superstar X-Factors, according to EA Sports. And since the Pro Bowl features the best non-Super Bowl players, it should be an over-the-top special-skills-based game.

There are X-Factor counters, of course. Madden NFL 20 is turning into a chess game of sorts, so putting pressure on a quarterback like Mahomes in the game will prevent him from getting into the zone and executing Superstar X-Factor moves like Bazooka. New mechanics like pump fake and the ability to cancel throws is really changing the game and mixing things up.

Playbooks are getting reworked in meaningful ways. There are new run pass options – 220 RPOs to be exact – being added to the game, as well as unique formations. Signature animations are coming to players and teams, and so are popular new plays like the renowned trick play Philly Special that was pulled off by the Philadelphia Eagles in the last football season. Best of all, as the real-life season is happening, your team's Madden 20 playbook can change.www.mutcoin.com

It's the nfl 20 madden coins off-season, so what better way to get excited for the season than speculation and conjecture on how our favorite players are going to perform in Madden 20 (out for PS4, Xbox One and PC on August 2nd). The complete player ratings for the game are out now, including the four elite players of the rarified 99 Club – Aaron Donald, Deandre Hopkins, Khalil Mack, and Bobby Wagner.

The game's official site has a handy menu you can filter to see players on each team and by position. Right now it reflects the players at launch, but this will be updated as the season progresses. Needless to say, not everyone agrees with what they are rated.
Madden fans and NFL players alike always have something to say about the game's ratings, but this reveal is also notable within the context that Madden 20 is stretching player ratings. EA Tiburon says the goal is to not only differentiate the league's stars, but also provide a wider spread of "starter-quality" players and a larger drop-off between starters and backups.

Do you agree that Aaron Rodgers isn't a top-five QB? A.J. Green is currently outside the WR top 10, but will he rise after returning from last year's injury? Let us know what you think in the comments section below.www.mutcoin.com

The "buy mut coins" release date is almost here and the popular video game series looks to take an extra step this season.
There are plenty of new features (which you can read all about below) that should excite football fans. Perhaps the most interesting part is the QB1 mode in which you will be able to play at the college level. You can only choose from 10 teams, but it has been so long that we've been able to play college football in a video game that we'll take whatever we can get.
Plus, with other modes such as Franchise, MUT, online and exhibition returning, there are plenty of ways to appreciate Madden this year.
Here's everything you'll need to know ahead of the "Madden NFL 20" release on Aug. 2, including cost, the difference between editions, new features, players ratings and how to play the game a few days before everyone else.
Aug. 2 is one of the earliest standard-edition release dates in the history of the franchise, which typically rolls out its new game toward the end of the month. That will allow gamers more time to get a feel for "Madden NFL 20" before the 2019 NFL season begins Sept. 5.
'Madden NFL 20' price: How much does each edition cost?
There are three versions of "Madden NFL 20" coming out: Standard, Superstar and Ultimate Superstar. Here's how the prices vary by edition and what you'll get for your money.
This game has all of the typical features you need. As the name suggests, it's your standard version of Madden with no added features or MUT upgrades.
'Madden NFL 20' Superstar Edition: $80
This version releases three days early and also contains 12 Gold Team Ultimate packs and one Training item. So, if you want to start on the sticks early, or if you're really into Madden Ultimate Team, then this version might be for you. Otherwise, it would make sense to wait and save the extra $20.
'Madden NFL 20' Ultimate Superstar Edition: $100
Similar to the superstar version, you get to play the game three days early, but this version comes with a few extra features like one QB Legend for your Ultimate Team, 16 Gold packs, one Core Elite player from any team and one Training item. If you enjoy Madden Ultimate Team, it'd make sense to go ahead and splurge for that extra $40. Otherwise, you're better off waiting three days for the standard version.Click Here

FIFA 20: Konami lock out EA Sports Will Cristiano Ronaldo be in cheap fifa 20 coins Ultimate Team after Juventus PES license? Many FUT fans will have heard the news that Juventus will not be a licensed team within FIFA 20. This has been confirmed since Juventus FC signed an exclusive deal with Konami for PES 2020. Does this mean that Cristiano Ronaldo will not have a FIFA 20 Ultimate Team card? Diehard FIFA fans can relax right now, Cristiano Ronaldo and other Juventus players will be in this year's Ultimate Team game mode. However, FUT 20 users will have to play with these players under the new club name of Piemonte Calcio, which will feature a custom badge and kits. The team Piemonte Calcio will consist of real-world, authentic players throughout all FIFA 20 game modes, as well as Ultimate Team. Furthermore, Piemonte Calcio players will have the exact same FUT Chemistry as any other team, essentially meaning that these changes will merely be superficial. No. The entire squad will use real-world players, with authentic names and faces, throughout FIFA 20 and the Ultimate Team game mode. Will these changes affect FUT chemistry? No. Piemonte Calcio players will share chemistry links like any other team, with players from the same Nation, League and Club. Will Piemonte Calcio players receive special cards? Yes, these players will be eligible for Special Items throughout the course of FIFA 20 Ultimate Team.FIFA 20 Career Mode users will be able to play with Piemonte Calcio, which will feature authentic players and updated player ratings. Are you relieved to hear the news that Cristiano Ronaldo and other Juventus players will still feature in FIFA 20 Ultimate Team under Piemonte Calcio? How will the Konami PES 2020 Juventus partnership license agreement affect FIFA games and FUT long-term? Share your thoughts with us via Twitter.Want to buy mut 19 coins from www.futcoin.com

FIFA 20 Release Date & Features: 9 Things to Know The FIFA 20 release date is September 27th with a new Street Soccer mode called Volta and upgrades to the game flow, movements and ball physics. This is what you need to know about the FIFA 20 release date, editions, new features and other key details. You can play fifa 20 ultimate team coins free with an EA Access or Origin Access subscription if you want to get your gaming in ahead of the release date and you can now pre-order FIFA 20..There are two FIFA 20 release dates that you need to pay attention to, and a third one if you want to play even earlier. The FIFA 20 release date is September 27th for the standard edition. If you buy one of the special editions, the FIFA 20 release date is September 24th. You can also expect an earlier option on Origin Access and EA Access that will allow you to play as early as September 19th for 10 hours of total gaming time.The standard FIFA 20 base game is $59.99, and you can spend up to $100 on the game if you want the top line digital option. . EA switched to three Madden 20 editions this year, and keeps things going with three FIFA 20 editions. This translates into the following FIFA 20 prices;Thanks to the FIFA 20 reveal trailer we know about the new Volta gameplay mode which is a street soccer style of gameplay. We get glimpses of in game graphics, but there’s no full on FIFA 20 gameplay video yet. We hope to see this in the near future as EA shares more information. New FIFA 20 Game Flow Features EA focuses on AI upgrades for the computer controlled players. This has been an area of focus for several years and this year we see three specific areas of change including;.The FIFA 20 FUT changes are under tight wraps, but expect a big focus on FUT as EA hired FUT Economist to work on EA Sports FIFA starting in June. Expect to learn more this summer as EA shares new details about the game. One thing we do expect is to see FUT missions which will allow you to unlock additional in-game content. This is a new feature in Madden Ultimate Team. We know that there will be FUT 20 iCON players that are legendary players from the past.want know more fut coins news Read More