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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
New Testo gel (Testavan)
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<blockquote data-quote="madman" data-source="post: 133659" data-attributes="member: 13851"><p><strong>SUMMARY </strong></p><p></p><p><em>Testosterone gel formulations have become a popular testosterone replacement therapy in patients with hypogonadism since their advent in the year 2000. The gel formulations restore testosterone levels to mid-normal physiological levels (14–17.5 nmol/L) as early as within 24 h and help alleviate the signs and symptoms of testosterone deficiency, thereby leading to an improved quality of life. Although testosterone gels have a favorable efficacy and safety profile as compared to injectable and patch formulations, the risk of secondary exposure poses a challenge. Approved testosterone topical formulations include Tostrex (Tostran, Fortesta), Androgel (Testogel), Testim, and Axiron (solution), which have a favorable efficacy profile and positively impact patient-reported outcome(s). Besides, <strong><span style="color: rgb(184, 49, 47)">Testavan, which is a 2% testosterone gel</span>, is under registration in Europe and already approved in Australia in May 2017. <span style="color: rgb(184, 49, 47)">Testavan uses a novel hydroalcoholic and highly viscous topical formulation</span>. This product comes with a metered dose dispenser and a cap applicator that allows a hands-free application for precise dispensing and application. </strong>The present article provides a comprehensive review of the pharmacokinetic, tolerability, and safety profiles of the testosterone gels available in the market along with the new 2% testosterone gel, Testavan.</em></p><p></p><p></p><p></p><p></p><p><strong>DEVELOPMENT OF TOPICAL TESTOSTERONE FORMULATIONS</strong></p><p></p><p><em>Androgel 1% was the first topical gel formulation developed. The starting dose is 5 g (50 mg testosterone), which could be applied by hand over the shoulders/both arms/ abdomen. As a line extension, it was also approved in the EU as Androgel 1.62%, with a starting dose of 2.50 g (40.5 mg of testosterone), dispensed by two pump actuations and applied by hand over both shoulders and upper arms (Swerdloff et al., 2000; Kaufman et al., 2011, 2012). Testim (Testosterone 1%) was the second gel developed as a unit dose of 5 g tube of 1% strength containing 50 mg of testosterone, applied to the shoulders by hand (Steidle et al., 2003). Another product, Tostrex (Tostran), was developed as a 2% gel with a starting dose of 3 g (60 mg of testosterone, the dose could range from 20 to 80 mg, 20 mg increments), which could be applied to the abdomen or inside of both thighs by hand using a pump dispenser (SmPC Tostran). Similar to Tostrex, Fortesta 2% is applied to the inner thighs with a starting dose of 40 mg testosterone, adjusted in 10 mg testosterone increments for dose flexibility, with a minimum dose of 10 mg and a maximum dose of 70 mg testosterone (Dobs et al., 2012). Axiron is a 2% testosterone solution, approved in the United States and in some EU countries as well, with a starting dose of 60 mg. It is delivered via a metered pump that delivers 3 mL (30 mg) of testosterone to each underarm with a single actuation (Khera, 2016).</em></p><p></p><p></p><p></p><p></p><p><strong><span style="color: rgb(0, 0, 0)"><em>Testavan, the new 2% testosterone gel, </em></span><span style="color: rgb(184, 49, 47)"><em>uses a novel hydroalcoholic and highly viscous topical formulation.</em></span></strong><em> The product is homogeneous, transparent, and non-staining, and comes in a metered dose dispenser that includes a hands-free cap applicator for precise dispensing and application. The starting dose is 23 mg testosterone, delivered by one pump actuation, contained in 1.15 g of gel, and the highest dose is 3.45 g of gel containing 69 mg testosterone (delivered by three pump actuation) (Efros et al., 2016).</em></p><p><em></em></p><p><em></em></p><p><em></em></p><p><em></em></p><p><em><strong>Compared to the other topical products, </strong></em><span style="color: rgb(184, 49, 47)"><strong><em>the amount of gel used with Testavan is generally less</em></strong></span><strong><em> than the other products </em></strong><span style="color: rgb(184, 49, 47)"><strong><em>due to its higher bioavailability owing to its composition.</em></strong></span><strong><em> In a randomized, active-controlled phase I study in down-regulated men, <span style="color: rgb(184, 49, 47)">Testavan showed higher testosterone bioavailability, while delivering more testosterone in a small volume as compared with Androgel</span> (Olsson et al., 2014). Also, there is no intended secondary exposure to the hands, which minimizes the risk of secondary exposure.</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Serum testosterone concentration</strong></p><p></p><p><em>Consistent with the guidelines, in two multicentre phase III studies, the mean Cave levels achieved with Testavan ranged from 12.8 to 17.5 nmol/L, similar to those achieved with Androgel 1.62%, Tostrex 2%, Fortesta 2% Testim 1% and Axiron solution (Table 1). Figure 2 shows the testosterone levels over time for Cave responders at Day 90 (Unpublished data).</em></p><p><em></em></p><p><em></em></p><p><em>Testavan gel provides the option of the lowest starting dose of 23 mg testosterone, which could go up to 46, and 69 mg as the maximum dose. <strong>The advantage of a lower starting dose <span style="color: rgb(184, 49, 47)">with Testavan comes from Ferring Advanced Skin Technology (FAST)</span>, a <span style="color: rgb(0, 0, 0)">proprietary topical gel technology developed by Ferring Pharmaceuticals.</span> FAST relies on<span style="color: rgb(184, 49, 47)"> a unique combination of volatile/nonvolatile solvents and permeation enhancers that temporarily increase the skin permeability and hence reduce the volume of applied gel without high residual volume. </span></strong>However, as with most of the topical agents, risk of secondary exposure, especially for women and children, and the washout of testosterone while rinsing hands or showering is expected with Testavan also and has been thoroughly evaluated.</em></p></blockquote><p></p>
[QUOTE="madman, post: 133659, member: 13851"] [B]SUMMARY [/B] [I]Testosterone gel formulations have become a popular testosterone replacement therapy in patients with hypogonadism since their advent in the year 2000. The gel formulations restore testosterone levels to mid-normal physiological levels (14–17.5 nmol/L) as early as within 24 h and help alleviate the signs and symptoms of testosterone deficiency, thereby leading to an improved quality of life. Although testosterone gels have a favorable efficacy and safety profile as compared to injectable and patch formulations, the risk of secondary exposure poses a challenge. Approved testosterone topical formulations include Tostrex (Tostran, Fortesta), Androgel (Testogel), Testim, and Axiron (solution), which have a favorable efficacy profile and positively impact patient-reported outcome(s). Besides, [B][COLOR=rgb(184, 49, 47)]Testavan, which is a 2% testosterone gel[/COLOR], is under registration in Europe and already approved in Australia in May 2017. [COLOR=rgb(184, 49, 47)]Testavan uses a novel hydroalcoholic and highly viscous topical formulation[/COLOR]. This product comes with a metered dose dispenser and a cap applicator that allows a hands-free application for precise dispensing and application. [/B]The present article provides a comprehensive review of the pharmacokinetic, tolerability, and safety profiles of the testosterone gels available in the market along with the new 2% testosterone gel, Testavan.[/I] [B]DEVELOPMENT OF TOPICAL TESTOSTERONE FORMULATIONS[/B] [I]Androgel 1% was the first topical gel formulation developed. The starting dose is 5 g (50 mg testosterone), which could be applied by hand over the shoulders/both arms/ abdomen. As a line extension, it was also approved in the EU as Androgel 1.62%, with a starting dose of 2.50 g (40.5 mg of testosterone), dispensed by two pump actuations and applied by hand over both shoulders and upper arms (Swerdloff et al., 2000; Kaufman et al., 2011, 2012). Testim (Testosterone 1%) was the second gel developed as a unit dose of 5 g tube of 1% strength containing 50 mg of testosterone, applied to the shoulders by hand (Steidle et al., 2003). Another product, Tostrex (Tostran), was developed as a 2% gel with a starting dose of 3 g (60 mg of testosterone, the dose could range from 20 to 80 mg, 20 mg increments), which could be applied to the abdomen or inside of both thighs by hand using a pump dispenser (SmPC Tostran). Similar to Tostrex, Fortesta 2% is applied to the inner thighs with a starting dose of 40 mg testosterone, adjusted in 10 mg testosterone increments for dose flexibility, with a minimum dose of 10 mg and a maximum dose of 70 mg testosterone (Dobs et al., 2012). Axiron is a 2% testosterone solution, approved in the United States and in some EU countries as well, with a starting dose of 60 mg. It is delivered via a metered pump that delivers 3 mL (30 mg) of testosterone to each underarm with a single actuation (Khera, 2016).[/I] [B][COLOR=rgb(0, 0, 0)][I]Testavan, the new 2% testosterone gel, [/I][/COLOR][COLOR=rgb(184, 49, 47)][I]uses a novel hydroalcoholic and highly viscous topical formulation.[/I][/COLOR][/B][I] The product is homogeneous, transparent, and non-staining, and comes in a metered dose dispenser that includes a hands-free cap applicator for precise dispensing and application. The starting dose is 23 mg testosterone, delivered by one pump actuation, contained in 1.15 g of gel, and the highest dose is 3.45 g of gel containing 69 mg testosterone (delivered by three pump actuation) (Efros et al., 2016). [B]Compared to the other topical products, [/B][/I][COLOR=rgb(184, 49, 47)][B][I]the amount of gel used with Testavan is generally less[/I][/B][/COLOR][B][I] than the other products [/I][/B][COLOR=rgb(184, 49, 47)][B][I]due to its higher bioavailability owing to its composition.[/I][/B][/COLOR][B][I] In a randomized, active-controlled phase I study in down-regulated men, [COLOR=rgb(184, 49, 47)]Testavan showed higher testosterone bioavailability, while delivering more testosterone in a small volume as compared with Androgel[/COLOR] (Olsson et al., 2014). Also, there is no intended secondary exposure to the hands, which minimizes the risk of secondary exposure.[/I] Serum testosterone concentration[/B] [I]Consistent with the guidelines, in two multicentre phase III studies, the mean Cave levels achieved with Testavan ranged from 12.8 to 17.5 nmol/L, similar to those achieved with Androgel 1.62%, Tostrex 2%, Fortesta 2% Testim 1% and Axiron solution (Table 1). Figure 2 shows the testosterone levels over time for Cave responders at Day 90 (Unpublished data). Testavan gel provides the option of the lowest starting dose of 23 mg testosterone, which could go up to 46, and 69 mg as the maximum dose. [B]The advantage of a lower starting dose [COLOR=rgb(184, 49, 47)]with Testavan comes from Ferring Advanced Skin Technology (FAST)[/COLOR], a [COLOR=rgb(0, 0, 0)]proprietary topical gel technology developed by Ferring Pharmaceuticals.[/COLOR] FAST relies on[COLOR=rgb(184, 49, 47)] a unique combination of volatile/nonvolatile solvents and permeation enhancers that temporarily increase the skin permeability and hence reduce the volume of applied gel without high residual volume. [/COLOR][/B]However, as with most of the topical agents, risk of secondary exposure, especially for women and children, and the washout of testosterone while rinsing hands or showering is expected with Testavan also and has been thoroughly evaluated.[/I] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
New Testo gel (Testavan)
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