Halotestin (Fluoxymesterone) - Summary

HALOTESTIN SUMMARY

Halotestin^® CIII
fluoxymesterone
tablets, USP

HALOTESTIN Tablets contain fluoxymesterone, an androgenic hormone. Fluoxymesterone is a white or nearly white, odorless, crystalline powder, melting at or about 240° C, with some decomposition. It is practically insoluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform.

In the male —HALOTESTIN Tablets are indicated for

1. Replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
   Primary hypogonadism (congenital or acquired) testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
   1. Hypogonadotropic hypogonadism (congenital or acquired)—idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
2. Delayed puberty, provided it has been definitely established as such, and is not just a familial trait.

In the female —HALOTESTIN Tablets are indicated for palliation of androgen-responsive recurrent mammary cancer in women who are more than one year but less than five years postmenopausal, or who have been proven to have a hormone- dependent tumor as shown by previous beneficial response to castration.

HALOTESTIN NEWS HIGHLIGHTS

Published Studies Related to Halotestin (Fluoxymesterone)

Randomized trial of tamoxifen alone or combined with fluoxymesterone as adjuvant therapy in postmenopausal women with resected estrogen receptor positive breast cancer. North Central Cancer Treatment Group Trial 89-30-52. [2006.07]

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Clinical Trials Related to Halotestin (Fluoxymesterone)

Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer [Recruiting]

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