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The number of transgender individuals seeking cross-sex hormone therapy has risen over the years (6). The administration of exogenous virilizing hormones is considered medically necessary for many transgender individuals (7). Many transgender men seek therapy for virilization and the mainstay treatment is exogenous testosterone. Transgender women desire suppression of androgenic effects and often use anti-androgen therapy with feminizing exogenous estrogens.

Ethinyl estradiol used to be the mainstay of most estrogen-directed therapies. This is no longer the case, as clinical evidence has showed a strong relationship between ethinyl estradiol and the incidence of deep venous thrombosis (13). As a result, there are strong recommendations against the use of ethinyl estradiol in transgender patients (8). Oral (Estrace, Gynodiol) and transdermal (Alora, Climera, Esclim, Estraderm, Vivelle) estradiol and parenteral estradiol valerate (Delestrogen) are currently the preferred formulations of estrogen. See Table 2 for dosing recommendations. No studies have examined the efficacy of the different formulations specific to transgender hormone management. After the age of 40, transdermal formulations are recommended as they bypass first pass metabolism and seem to be associated with better metabolic profiles (14).

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Adolescents also seek hormone therapy for treatment of gender dysphoria. The purpose of this review was to cover guidelines and management for adult patients, but it is important to mention special considerations that must be taken when treating adolescent patients. Cross-sex hormones are usually recommended at the age of sixteen (7). However, in some situations when delay of therapy may lead to psychologic and cognitive trauma in a child, it may be appropriate to commence therapy earlier (34). In these cases, and most adolescent cases, it is important to have a multi-disciplinary approach to treatment and management, and parental support is imperative. In youth who have reached Tanner Stage 2 development, GnRH agonists are used to suppress endogenous hormones to avoid full pubertal development and cross-sex hormone therapy is initiated by or at age sixteen. There are many ethical issues to address in the care of the adolescent transgender patient, and the care of this patient population should be left to specialists who are well versed in this type of care.

The goal of feminizing hormone therapy is the development of female secondary sex characteristics, and suppression/minimization of male secondary sex characteristics. General effects include breast development (usually to Tanner stage 2 or 3), a redistribution of facial and body subcutaneous fat, reduction of muscle mass, reduction of body hair (and to a lesser extent, facial hair), change in sweat and odor patterns, and arrest and possible reversal of scalp hair loss. Sexual and gonadal effects include reduction in erectile function, changes in libido, reduced or absent sperm count and ejaculatory fluid, and reduced testicular size. Feminizing hormone therapy also brings about changes in emotional and social functioning. The general approach of therapy is to combine an estrogen with an androgen blocker, and in some cases a progestogen.

The primary class of estrogen used for feminizing therapy is 17-beta estradiol, which is a "bioidentical" hormone in that it is chemically identical to that from a human ovary. The general approach is similar to estrogen replacement in agonadal (i.e., Turner syndrome) or menopausal states, with some dosing modifications. 17-beta estradiol (or simply estradiol) is most commonly delivered to transgender women via a transdermal patch, oral tablet, or injection of a conjugated ester (estradiol valerate or estradiol cypionate). No outcome studies have been conducted on injectable estradiol valerate or cypionate, presumably due to their uncommon modern use outside of transgender care settings; due to this limited use, manufacturers have little incentive to produce this medicine, and shortages have been reported. Other delivery routes for estradiol such as transdermal gel or spray are formulated for the treatment of menopausal vasomotor symptoms and while convenient and effective in some transgender women, in others these routes may not be able to achieve blood levels in the physiologic female range. Compounded topical creams and gels also exist from specialty pharmacies; if these are to be used it is recommended that the prescriber consult with the compounding pharmacist to understand the specific details and dosing of the individual preparation. Compounded estradiol valerate or cypionate for injection also exists, and may be an alternative in times of shortage or more cost effective for those who must pay cash for their prescriptions.

Antiandrogens can also be used alone to bring reduced masculinization and minimal breast development, or in those patients who wish to first explore reduced testosterone levels alone, or in those with contraindications to estrogen therapy. In the absence of estrogen replacement, some patients may have unpleasant symptoms of hot flashes and low mood or energy. Long term full androgen blockade without hormone replacement in men who have undergone treatment for prostate cancer results in bone loss, and this effect would also be expected to occur in transgender individuals.[10] In addition to titrating dosing to both clinical effect and testosterone levels as guided by patient goals, monitoring hormone levels to insure suppressed gonadotropins (luteinizing hormone [LH] and follicle stimulating hormone [FSH]) levels may serve as a surrogate marker to indicate adequate sex hormone levels for maintaining bone density in such patients (Grading: T O W).[11]

In some patients, complete androgen blockade may be difficult or even impossible using standard regimens. In cases of persistent elevations of testosterone in the setting of maximal antiandrogen dosing with good medication adherence, autonomous endogenous production (i.e. tumor) as well as undisclosed exogenous testosterone (i.e. to maintain erectile function) should be considered. An evaluation for testicular neoplasms should be performed with a scrotal exam as well as testing for elevated serum human choriogonadotropin (hCG), lactate dehydrogenase (LDH), alpha-fetoprotein (AFP) levels, and possibly scrotal imaging.[14] Once these causes have been ruled out, additional options can include gonadotropin releasing hormone analogues (GnRH) or orchiectomy. GnRH analogs are used routinely in the care of peripubertal transgender youth who require pubertal delay,[15] and have been described in the care of transgender adults as well.[16] Drawbacks to the use of GnRH analogs is primarily related to cost and difficulties in obtaining insurance coverage, as well as the need for either repeated injections, multiple daily nasal sprays, or surgical implantation. Orchiectomy may represent an ideal option in transgender women who do not desire to retain their gonads; this brief, inexpensive, outpatient procedure requires only several days for recovery and does not preclude future vaginoplasty.

Progestogens: There have been no well-designed studies of the role of progestogens in feminizing hormone regimens. Many transgender women and providers alike report an anecdotal improved breast and/or areolar development, mood, or libido with the use of progestogens.[17,18] There is no evidence to suggest that using progestogens in the setting of transgender care are harmful. In reality some patients may respond favorably to progestogens while others may find negative effects on mood. While progestogens have some anti-androgen effect through central blockade of gonadotropins, there is also a theoretical risk of a direct androgenizing effect of progestogens. This class includes micronized bioidentical progesterone (Prometrium) as well as a number of synthetic progestins. The most commonly used synthetic progestin in the context of transgender care is the oral medroxyprogesterone acetate (Provera).

While concerns exist from the Women's Health Initiative (WHI) regarding risks of cardiovascular disease and breast cancer in the setting of medroxyprogesterone use, these concerns likely do not apply in the context of transgender care for several reasons. First, the transgender women may be at lower risk of breast cancer than non-transgender women. Second, this arm of the WHI involved the use of conjugated equine estrogens in combination with medroxyprogesterone in a sample of menopausal women, some of whom were as long as 10 years post-menopausal at the time of hormone initiation. Third, while statistically significant, the clinical significance of the findings in the WHI was subtle at best. The study aimed to evaluate the role of menopausal hormone therapy in the prevention of chronic disease. The actual findings in the conjugated equine estrogen plus medroxyprogesterone group were an excess absolute risk per 10 000 person-years of 7 more cardiac events, 8 more strokes, 8 more pulmonary emboli, and 8 more invasive breast cancers, with no change in overall mortality.[19] As such this arm of the WHI was stopped early, and it was concluded that combined menopausal hormone therapy is not indicated for prevention of chronic disease.

Many patients are eager to begin maximal feminizing hormone therapy and are opposed to the idea of a slow upward titration. Weak evidence suggests that initiation of estrogen therapy at lower doses and titrating up over time may result in enhanced breast development in transgender women. The estrogen receptor agonist activity of spironolactone may play a role in reduced breast development due to premature breast bud fusion. As such an escalating regimen beginning with low dose estrogen only, and titrating up over several months, and then adding spironolactone may be an alternative approach,[17] consistent with management practices in children with delayed pubertal onset (Grading: T O W). Upward titration of spironolactone can also help minimize side effects such as orthostasis or polyuria. It is recommended that providers discuss these considerations with patients before initiation of hormones in order to make an informed decision. 2351a5e196