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Halotestin (Fluoxymesterone) - Summary



Halotestin® CIII
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.

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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.

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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.

HAL-MPE1 First-in-human [Recruiting]

HAL-RAR Versus Hemorrhoidectomy in the Treatment of Grade III-IV Hemorrhoids. Prospective, Randomized Trial [Not yet recruiting]
HYPOTHESIS 1. HAL- RAR causes a lower immediate postoperative pain compared with erxcision hemorrhoidectomy.

2. HAL - RAR achieves similar immediate and long term results compared to the excision

hemorrhoidectomy in the control of hemorrhoidal symptoms. 3. The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy. OBJECTIVES 1. Compare postoperative pain of both techniques. 2. Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique, and compare the results with those of the excision hemorrhoidectomy. 3. Evaluate and compare the rate of complications of both techniques. 4. Assess the quality of life of patients before and after treatment. MATERIAL AND METHODS The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation). All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with both methods who agree to participate in the study, will be included in the prospective randomized trial. All patients will be required to sign the specific informed consent. Patients who are suitable for treatment with both techniques will be randomly assigned to the surgical technique. Inclusion criteria: 1. Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or prolapse) that are eligible for surgical treatment with both methods. Exclusion criteria: 1. Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure, perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal stenosis. 2. Prior anorectal surgery . 3. Systemic pathology that could alter the outcome of the surgery as coagulopathies, chronic pain with continued consumption of analgesics. 4. Age younger than 18 or older than 80 years, socio-pathology or inability to understand the study objectives. All surgeries are performed on an outpatient basis under regional anesthesia and sedation for the same team of three surgeons. Preoperative preparation consists of a cleansing enema and no prophylactic antibiotics will be administered.

Both techniques will be performed in "Jack - Knife" position. The open hemorrhoidectomy may

include one to three anal cushions and made according to the Milligan-Morgan technique, with resection of the anal cushion and the external hemorrhoidal epidermal component using electrocautery and ligation of the hemorroidal base with absorbable suture. Once completed hemorrhoidectomy a perianal block is performed with bupivacaine/epinephrine. Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently, a running suture was added from the suture point to 5 mm above the dentate line to lift the prolapsing hemorroid. Other procedures will not be associated, if necessary, the patient will be excluded from the study . The patient will be discharged if adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after examination by the surgeon in order to discard immediate complications. The ambulatory treatment consists of an osmotic laxative (magnesium hydroxide ), oral analgesia with paracetamol/tramadol ( 325mg/37. 5mg ) every 6 hours and Dexketoprofen (25 mg) every 8 hours, metamizol (575 mg) may be associated every 8 hours if pain. In case of persistent pain, the patient will be examinated in emergency room. EVALUATION OF RESULTS A power analysis was performed to assess the study sample size. Choosing a power of 0. 8 and a confidence interval of 95% α-error of 0. 05, we calculated that 26 patients were needed in each arm. We increased this number up to 30 to increase reliability of the study. All patients will be evaluated with a validated questionnaire of 36 questions on quality of life ( SF-36 ) and specific questions about specific symptoms of hemorrhoidal disease (pain, itching , bleeding, soiling and hemorrhoidal prolapse reduction ). The questionnaire will be answered before the intervention, after six and twelve months of follow up. All patients will complete a diary testing global postoperative pain every day, measured on a numerical scale from 0 to 10 during the first 15 days. The patients will be assessed on the day of discharge and at 7, 14, and 30 postoperative days. The patients will be evaluated at 6, 12 and 24 postoperative months in the outpatient clinic.

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Page last updated: 2007-02-13

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