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Testosterone Replacement, Low T, HCG, & Beyond
Clomid for PCT, fertility or low T
Enclomiphene citrate: A treatment that maintains fertility in men with secondary hypogonadism
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<blockquote data-quote="madman" data-source="post: 148015" data-attributes="member: 13851"><p><strong><span style="color: rgb(184, 49, 47)">ABSTRACT</span></strong></p><p><strong></strong></p><p><strong><span style="color: rgb(0, 0, 0)">Introduction:</span></strong> <em>Hypogonadism is an important issue among the male population. Treatments such as exogenous testosterone have become very popular. One of the adverse effects of testosterone is its suppression of fertility. This has led to the use of alternative therapies such as selective estrogen receptor modulators (SERMs) that aim to correct hypogonadism without reducing fertility.</em></p><p></p><p><strong>Areas covered: </strong><em>The SERM, clomiphene citrate, which is approved by the FDA for the treatment of ovarian dysfunction, has been shown to have beneficial effects on male hypogonadism. Clomiphene citrate exists as a mixture of both the cis-isomer (zuclomiphene) and the trans-isomer (enclomiphene). The literature has suggested that most of the beneficial effects of clomiphene are due to the trans-isomer enclomiphene. Zuclomiphene contributes little to the intended outcomes. The purpose of this drug profile is to examine the available literature on trans-isomer enclomiphene.</em></p><p><em></em></p><p><em>[ATTACH=full]40938[/ATTACH]</em></p><p></p><p><strong>Expert opinion: <span style="color: rgb(26, 188, 156)"><em>Enclomiphene </em></span><em>has been shown to <span style="color: rgb(184, 49, 47)">increase testosterone levels </span>while <span style="color: rgb(184, 49, 47)">stimulating FSH and LH production</span></em></strong><em><span style="color: rgb(184, 49, 47)">. </span><strong>Initial studies demonstrated that <span style="color: rgb(26, 188, 156)">enclomiphene </span><span style="color: rgb(184, 49, 47)">maintains the androgenic benefit</span> of <span style="color: rgb(44, 130, 201)">clomiphene citrate</span> without <span style="color: rgb(184, 49, 47)">the undesirable effects</span> attributable to <span style="color: rgb(184, 49, 47)">zuclomiphene.</span></strong> <span style="color: rgb(0, 0, 0)"><strong>This article reviews the </strong></span><span style="color: rgb(184, 49, 47)"><strong>difficulties</strong></span><span style="color: rgb(0, 0, 0)"><strong> associated with the </strong></span><span style="color: rgb(184, 49, 47)"><strong>FDA approval</strong></span><span style="color: rgb(0, 0, 0)"><strong> of a </strong></span><span style="color: rgb(26, 188, 156)"><strong>new molecular entity</strong></span><span style="color: rgb(0, 0, 0)"><strong> related to the treatment of </strong></span></em><span style="color: rgb(184, 49, 47)"><strong><em>hypogonadism. </em></strong></span></p><p></p><p></p><p></p><p></p><p><strong><span style="color: rgb(0, 0, 0)">Article highlights</span></strong></p><p></p><p>● <strong><span style="color: rgb(44, 130, 201)"><em>Clomiphene Citrate</em></span></strong> <strong><em>is used <span style="color: rgb(184, 49, 47)">off-label</span> to treat <span style="color: rgb(184, 49, 47)">secondary hypogonadism</span> in men </em><span style="color: rgb(184, 49, 47)"><em>desiring to preserve fertility </em></span></strong></p><p></p><p>● <strong><em>The <span style="color: rgb(26, 188, 156)">active isomer</span> of <span style="color: rgb(44, 130, 201)">clomiphene</span> is <span style="color: rgb(26, 188, 156)">enclomiphene</span> while the other isomer <span style="color: rgb(184, 49, 47)">zuclomiphene</span> may actually <span style="color: rgb(184, 49, 47)">antagonize</span> the desired effects</em></strong></p><p></p><p>●<strong><span style="color: rgb(26, 188, 156)"> <em>Enclomiphene </em></span><em>has been shown to <span style="color: rgb(184, 49, 47)">raise testosterone levels</span> in a similar fashion to </em><span style="color: rgb(184, 49, 47)"><em>transdermal testosterone </em></span></strong></p><p></p><p>● <strong><span style="color: rgb(26, 188, 156)"><em>Enclomiphene</em></span><em> has also been shown to <span style="color: rgb(184, 49, 47)">preserve sperm concentration </span>when compared with <span style="color: rgb(184, 49, 47)">exogenous testosterone replacement</span> </em></strong></p><p></p><p>● <strong><em>No <span style="color: rgb(184, 49, 47)">rigorous studies</span> have demonstrated <span style="color: rgb(184, 49, 47)">symptomatic benefits</span> with </em><span style="color: rgb(26, 188, 156)"><em>enclomiphene </em></span></strong></p><p></p><p>● <strong><em>The<span style="color: rgb(184, 49, 47)"> FDA</span> <span style="color: rgb(44, 130, 201)">denied the approval </span>of enclomiphene on the grounds that </em><span style="color: rgb(184, 49, 47)"><em>no symptomatic benefit was identified</em></span></strong></p><p></p><p> <strong>● <span style="color: rgb(26, 188, 156)"><em>Enclomiphene </em></span><em>serves as an example of <span style="color: rgb(184, 49, 47)">how difficult</span> it is to <span style="color: rgb(184, 49, 47)">gain approval </span>for a <span style="color: rgb(26, 188, 156)">new molecular entity</span> for the treatment of <span style="color: rgb(184, 49, 47)">secondary hypogonadism</span></em></strong></p><p><strong><em></em></strong></p><p><strong><em></em></strong></p><p><strong><em></em></strong></p><p><strong><em></em></strong></p><p><strong><em>In summary,<span style="color: rgb(26, 188, 156)"> enclomiphene</span><span style="color: rgb(0, 0, 0)"> i</span>s a <span style="color: rgb(184, 49, 47)">very promising drug</span> for patients with<span style="color: rgb(184, 49, 47)"> secondary hypogonadism </span>and who are <span style="color: rgb(184, 49, 47)">concerned about the negative effects of exogenous testosterone. </span><span style="color: rgb(44, 130, 201)">Despite the fact</span> that there was <span style="color: rgb(44, 130, 201)">clearly demonstrated efficacy without any substantial safety issues.</span> The <span style="color: rgb(184, 49, 47)">lack </span>of <span style="color: rgb(184, 49, 47)">clearly demonstrated symptomatic improvement in phase III studies </span><span style="color: rgb(41, 105, 176)">prevented</span><span style="color: rgb(26, 188, 156)"> enclomiphene</span> from obtaining <span style="color: rgb(184, 49, 47)">FDA approval.</span> The <span style="color: rgb(184, 49, 47)">difficulty of demonstrating a symptomatic benefit</span> for<span style="color: rgb(184, 49, 47)"> secondary hypogonadism </span>may prove a <span style="color: rgb(44, 130, 201)">substantial barrier</span> for years to come. </em></strong></p></blockquote><p></p>
[QUOTE="madman, post: 148015, member: 13851"] [B][COLOR=rgb(184, 49, 47)]ABSTRACT[/COLOR] [COLOR=rgb(0, 0, 0)]Introduction:[/COLOR][/B] [I]Hypogonadism is an important issue among the male population. Treatments such as exogenous testosterone have become very popular. One of the adverse effects of testosterone is its suppression of fertility. This has led to the use of alternative therapies such as selective estrogen receptor modulators (SERMs) that aim to correct hypogonadism without reducing fertility.[/I] [B]Areas covered: [/B][I]The SERM, clomiphene citrate, which is approved by the FDA for the treatment of ovarian dysfunction, has been shown to have beneficial effects on male hypogonadism. Clomiphene citrate exists as a mixture of both the cis-isomer (zuclomiphene) and the trans-isomer (enclomiphene). The literature has suggested that most of the beneficial effects of clomiphene are due to the trans-isomer enclomiphene. Zuclomiphene contributes little to the intended outcomes. The purpose of this drug profile is to examine the available literature on trans-isomer enclomiphene. [ATTACH type="full"]40938[/ATTACH][/I] [B]Expert opinion: [COLOR=rgb(26, 188, 156)][I]Enclomiphene [/I][/COLOR][I]has been shown to [COLOR=rgb(184, 49, 47)]increase testosterone levels [/COLOR]while [COLOR=rgb(184, 49, 47)]stimulating FSH and LH production[/COLOR][/I][/B][I][COLOR=rgb(184, 49, 47)]. [/COLOR][B]Initial studies demonstrated that [COLOR=rgb(26, 188, 156)]enclomiphene [/COLOR][COLOR=rgb(184, 49, 47)]maintains the androgenic benefit[/COLOR] of [COLOR=rgb(44, 130, 201)]clomiphene citrate[/COLOR] without [COLOR=rgb(184, 49, 47)]the undesirable effects[/COLOR] attributable to [COLOR=rgb(184, 49, 47)]zuclomiphene.[/COLOR][/B] [COLOR=rgb(0, 0, 0)][B]This article reviews the [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]difficulties[/B][/COLOR][COLOR=rgb(0, 0, 0)][B] associated with the [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]FDA approval[/B][/COLOR][COLOR=rgb(0, 0, 0)][B] of a [/B][/COLOR][COLOR=rgb(26, 188, 156)][B]new molecular entity[/B][/COLOR][COLOR=rgb(0, 0, 0)][B] related to the treatment of [/B][/COLOR][/I][COLOR=rgb(184, 49, 47)][B][I]hypogonadism. [/I][/B][/COLOR] [B][COLOR=rgb(0, 0, 0)]Article highlights[/COLOR][/B] ● [B][COLOR=rgb(44, 130, 201)][I]Clomiphene Citrate[/I][/COLOR][/B] [B][I]is used [COLOR=rgb(184, 49, 47)]off-label[/COLOR] to treat [COLOR=rgb(184, 49, 47)]secondary hypogonadism[/COLOR] in men [/I][COLOR=rgb(184, 49, 47)][I]desiring to preserve fertility [/I][/COLOR][/B] ● [B][I]The [COLOR=rgb(26, 188, 156)]active isomer[/COLOR] of [COLOR=rgb(44, 130, 201)]clomiphene[/COLOR] is [COLOR=rgb(26, 188, 156)]enclomiphene[/COLOR] while the other isomer [COLOR=rgb(184, 49, 47)]zuclomiphene[/COLOR] may actually [COLOR=rgb(184, 49, 47)]antagonize[/COLOR] the desired effects[/I][/B] ●[B][COLOR=rgb(26, 188, 156)] [I]Enclomiphene [/I][/COLOR][I]has been shown to [COLOR=rgb(184, 49, 47)]raise testosterone levels[/COLOR] in a similar fashion to [/I][COLOR=rgb(184, 49, 47)][I]transdermal testosterone [/I][/COLOR][/B] ● [B][COLOR=rgb(26, 188, 156)][I]Enclomiphene[/I][/COLOR][I] has also been shown to [COLOR=rgb(184, 49, 47)]preserve sperm concentration [/COLOR]when compared with [COLOR=rgb(184, 49, 47)]exogenous testosterone replacement[/COLOR] [/I][/B] ● [B][I]No [COLOR=rgb(184, 49, 47)]rigorous studies[/COLOR] have demonstrated [COLOR=rgb(184, 49, 47)]symptomatic benefits[/COLOR] with [/I][COLOR=rgb(26, 188, 156)][I]enclomiphene [/I][/COLOR][/B] ● [B][I]The[COLOR=rgb(184, 49, 47)] FDA[/COLOR] [COLOR=rgb(44, 130, 201)]denied the approval [/COLOR]of enclomiphene on the grounds that [/I][COLOR=rgb(184, 49, 47)][I]no symptomatic benefit was identified[/I][/COLOR][/B] [B]● [COLOR=rgb(26, 188, 156)][I]Enclomiphene [/I][/COLOR][I]serves as an example of [COLOR=rgb(184, 49, 47)]how difficult[/COLOR] it is to [COLOR=rgb(184, 49, 47)]gain approval [/COLOR]for a [COLOR=rgb(26, 188, 156)]new molecular entity[/COLOR] for the treatment of [COLOR=rgb(184, 49, 47)]secondary hypogonadism[/COLOR] In summary,[COLOR=rgb(26, 188, 156)] enclomiphene[/COLOR][COLOR=rgb(0, 0, 0)] i[/COLOR]s a [COLOR=rgb(184, 49, 47)]very promising drug[/COLOR] for patients with[COLOR=rgb(184, 49, 47)] secondary hypogonadism [/COLOR]and who are [COLOR=rgb(184, 49, 47)]concerned about the negative effects of exogenous testosterone. [/COLOR][COLOR=rgb(44, 130, 201)]Despite the fact[/COLOR] that there was [COLOR=rgb(44, 130, 201)]clearly demonstrated efficacy without any substantial safety issues.[/COLOR] The [COLOR=rgb(184, 49, 47)]lack [/COLOR]of [COLOR=rgb(184, 49, 47)]clearly demonstrated symptomatic improvement in phase III studies [/COLOR][COLOR=rgb(41, 105, 176)]prevented[/COLOR][COLOR=rgb(26, 188, 156)] enclomiphene[/COLOR] from obtaining [COLOR=rgb(184, 49, 47)]FDA approval.[/COLOR] The [COLOR=rgb(184, 49, 47)]difficulty of demonstrating a symptomatic benefit[/COLOR] for[COLOR=rgb(184, 49, 47)] secondary hypogonadism [/COLOR]may prove a [COLOR=rgb(44, 130, 201)]substantial barrier[/COLOR] for years to come. [/I][/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Clomid for PCT, fertility or low T
Enclomiphene citrate: A treatment that maintains fertility in men with secondary hypogonadism
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