The most relevant forms of secondary hypogonadism
are prolactinemia, which has several etiologies and thus a variable prevalence, and Kallmann syndrome, which affects 1 in 10 000.
There appear to be two separate tracks to primary hypogonadism marked by testicular dysfunction: secondary hypogonadism
and compensated hypogonadism.
Fispemifene's product profile offers an exciting next-generation treatment option for men suffering from urological conditions such as secondary hypogonadism
, in an existing multi-billion dollar market.
If luteinizing hormone and follicle-stimulating hormone levels are low (or inappropriately normal), secondary hypogonadism
is diagnosed and hypothalamic/pituitary pathologies should be considered (11, 12) depending on the patient's presentation.
The drug is being developed for the treatment of secondary hypogonadism
, or a defect of the gonads that results in the underproduction of testosterone.
Fispemifene is a new, selective estrogen receptor antagonist that is in Phase 2 studies as an oral treatment for the symptoms of secondary hypogonadism
Before transplantation, 3 had primary hypogonadism, and 2 had secondary hypogonadism
R])(NasdaqCM:RPRX) today reported it has submitted to the FDA a reanalysis of the previously completed 200 subject trial ZA-003 of Androxal([R]) in the treatment of secondary hypogonadism
as noted by Repros in the Company's press release of November 9, 2010.
The Company planned on seeking guidance on its planned New Drug Application (NDA) for Androxal for the treatment of secondary hypogonadism
with preservation of testicular function.
Patients with secondary hypogonadism
(hypothalamic-pituitary) have low T and normal LH and FSH levels.
The small study involved men with secondary hypogonadism
who were receiving testosterone replacement treatment.
Androgen replacement should be considered for men on high-dose ICSs who are found to have secondary hypogonadism
with low testosterone levels.