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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Sexual Problems in Men With Alopecia Treated With Oral Finasteride- Are Topical Solutions Better?
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<blockquote data-quote="madman" data-source="post: 125584" data-attributes="member: 13851"><p><strong>Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia </strong></p><p></p><p><em>Generally, 1-mg oral finasteride is well tolerated with long-term use, although evidence from preclinical and clinical studies points to significant adverse effects of 5α-reductase inhibitors on health and overall quality of life. Adverse sexual effects have consistently been reported [1, 13, 14]. In multiple double-blind randomized controlled trials, 1-mg oral finasteride has been associated with a significant number of sexual dysfunctions, including decreased libido (1.8%), erectile dysfunction (1.3%), ejaculation disorders and orgasm disorders (0.4%) [12, 14, 15, 16]. <strong>It is likely that a lack of plasmatic DHT or another 5α-reduced hormone is responsible for the reported decrease in libido and/or orgasm [17]. </strong>Recently, the use of 1 mg oral finasteride for the treatment of male pattern hair loss has been the focus of media and internet attention for potential irreversible sexual dysfunction and severe depression, which raises concerns about the safety of 1-mg oral finasteride [18].</em></p><p><em></em></p><p><em>Given the efficacy and a concerning side effect profile of oral finasteride, there is potential for the development of a better-tolerated formulation for male pattern baldness.</em></p><p><em></em></p><p><em><strong> A topical formulation of finasteride 0.25% solution (namely P-3074), in hydroxypropyl chitosan (HPCH) film-forming technology, allows finasteride to act on the scalp skin follicular portion of the bulb [19] and to promote a cutaneous depot of finasteride in the region of hair bulbs, thus minimizing systemic absorption even after repeated treatments [20].</strong> A recent study in 24 healthy men with androgenetic alopecia [21] showed that 1-week treatment with 1 mL P-3074 applied twice daily (b.i.d.) to the scalp and with finasteride 1-mg tablet orally administered once daily (o.d.) resulted in a similar plasma DHT reduction: plasma DHT was in fact reduced by 68 – 75% with P-3074 and by 62 – 72% with the reference tablet. As expected, no relevant changes in plasma testosterone occurred with either treatment. <span style="color: rgb(184, 49, 47)"><strong>Notably, plasma finasteride rate and extent of systemic absorption were ~ 10 - 15 times lower for the topical solution than for the tablet.</strong></span></em></p><p><em></em></p><p><em>On the basis of the results of the previous study, the present set of studies aimed at further investigating the systemic and local (scalp) DHT suppressive effects of P-3074, topically applied at different dose regimens (1 mL o.d. or b.i.d., study I) and at different o.d. doses (study II) in men with androgenetic alopecia.</em></p><p><em></em></p><p><em>Primary objective of study I was to investigate whether multiple applications of 1 mL P-3074 o.d. resulted in an inhibition of scalp and serum DHT similar to that obtained with b.i.d. applications and with the 1-mg oral tablet. Study II was designed to evaluate whether lower doses of P-3074 applied to the scalp of men with androgenetic alopecia could achieve the same inhibitory effect on scalp DHT levels, minimizing at the same time the systemic effects on serum DHT. Four doses of P-3074, as 4 different volumes (i.e., 100 µL (0.2275 mg), 200 µL (0.455 mg), 300 µL (0.6825 mg), and 400 µL (0.91 mg)) were thus investigated in terms of their effects on scalp DHT levels. In both studies, serum testosterone was also evaluated. The final aim was to optimize finasteride delivery from the new topical formulation, reducing finasteride systemic absorption and minimizing its systemic effects.</em></p></blockquote><p></p>
[QUOTE="madman, post: 125584, member: 13851"] [B]Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia [/B] [I]Generally, 1-mg oral finasteride is well tolerated with long-term use, although evidence from preclinical and clinical studies points to significant adverse effects of 5α-reductase inhibitors on health and overall quality of life. Adverse sexual effects have consistently been reported [1, 13, 14]. In multiple double-blind randomized controlled trials, 1-mg oral finasteride has been associated with a significant number of sexual dysfunctions, including decreased libido (1.8%), erectile dysfunction (1.3%), ejaculation disorders and orgasm disorders (0.4%) [12, 14, 15, 16]. [B]It is likely that a lack of plasmatic DHT or another 5α-reduced hormone is responsible for the reported decrease in libido and/or orgasm [17]. [/B]Recently, the use of 1 mg oral finasteride for the treatment of male pattern hair loss has been the focus of media and internet attention for potential irreversible sexual dysfunction and severe depression, which raises concerns about the safety of 1-mg oral finasteride [18]. Given the efficacy and a concerning side effect profile of oral finasteride, there is potential for the development of a better-tolerated formulation for male pattern baldness. [B] A topical formulation of finasteride 0.25% solution (namely P-3074), in hydroxypropyl chitosan (HPCH) film-forming technology, allows finasteride to act on the scalp skin follicular portion of the bulb [19] and to promote a cutaneous depot of finasteride in the region of hair bulbs, thus minimizing systemic absorption even after repeated treatments [20].[/B] A recent study in 24 healthy men with androgenetic alopecia [21] showed that 1-week treatment with 1 mL P-3074 applied twice daily (b.i.d.) to the scalp and with finasteride 1-mg tablet orally administered once daily (o.d.) resulted in a similar plasma DHT reduction: plasma DHT was in fact reduced by 68 – 75% with P-3074 and by 62 – 72% with the reference tablet. As expected, no relevant changes in plasma testosterone occurred with either treatment. [COLOR=rgb(184, 49, 47)][B]Notably, plasma finasteride rate and extent of systemic absorption were ~ 10 - 15 times lower for the topical solution than for the tablet.[/B][/COLOR] On the basis of the results of the previous study, the present set of studies aimed at further investigating the systemic and local (scalp) DHT suppressive effects of P-3074, topically applied at different dose regimens (1 mL o.d. or b.i.d., study I) and at different o.d. doses (study II) in men with androgenetic alopecia. Primary objective of study I was to investigate whether multiple applications of 1 mL P-3074 o.d. resulted in an inhibition of scalp and serum DHT similar to that obtained with b.i.d. applications and with the 1-mg oral tablet. Study II was designed to evaluate whether lower doses of P-3074 applied to the scalp of men with androgenetic alopecia could achieve the same inhibitory effect on scalp DHT levels, minimizing at the same time the systemic effects on serum DHT. Four doses of P-3074, as 4 different volumes (i.e., 100 µL (0.2275 mg), 200 µL (0.455 mg), 300 µL (0.6825 mg), and 400 µL (0.91 mg)) were thus investigated in terms of their effects on scalp DHT levels. In both studies, serum testosterone was also evaluated. The final aim was to optimize finasteride delivery from the new topical formulation, reducing finasteride systemic absorption and minimizing its systemic effects.[/I] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Sexual Problems in Men With Alopecia Treated With Oral Finasteride- Are Topical Solutions Better?
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