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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.


See all Halotestin indications & dosage >>

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]
PURPOSE: This clinical trial evaluated the addition of fluoxymesterone (Flu) to tamoxifen (Tam) in women with resected early stage breast cancer and attempted to corroborate the findings of superiority for the combination over Tam alone seen in a previous randomized trial in metastatic disease... CONCLUSIONS: This clinical trial did not demonstrate superiority of Tam plus Flu over Tam alone as adjuvant therapy for postmenopausal women with resected early breast cancer known to be ER positive.

more studies >>

Clinical Trials Related to Halotestin (Fluoxymesterone)

Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia [Recruiting]
An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).

Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1 [Recruiting]
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone) [Recruiting]
This study is being done to better understand why people with HIV who have taken drugs for HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is called lipodystrophy.

Patients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous (sc) fat from the arms, legs, and face and excess fat gain in the neck and truncal region. They also more likely to have problems with insulin in the body, high fat levels in the blood and diabetes. The reason that lipodystrophy develops is not fully understood although some HIV drugs have are very likely the cause. The complications pose an increased risk of fat blockage forming in the arteries making you more at risk for heart problems in the future. Changes in body fat can cause physical discomfort and psychological distress. Management of these problems can be a challenge for the patient's doctor.

The investigators propose data collection to determine if there is more than one reason why this might happen in some people and not in others. Laboratory samples being collected: 1) special imaging of the liver; 2) fat collected by needle from the mid thigh and mid-shoulder areas; 3) blood samples to measure the virus, t-cells, fats, and other markers of how the patient's body is handling the virus.

This study is being done because science does not fully understand why some patients with HIV who take medicines for the virus have abnormal fat loss or gain and some do not. This research study is intended to help us better understand why and how this happens.

A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP) [Not yet recruiting]

Immunotherapy Study in Progressive or Relapsed Non-Small Cell Lung Cancer [Recruiting]
The purpose of this study is to assess overall survival of anti-tumor immunization using HyperAcuteŽ-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.

more trials >>


Page last updated: 2007-02-13

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