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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.

See all Halotestin indications & dosage >>


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)

HAL-MPE1 First-in-human [Completed]

Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia [Completed]
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).

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.

An Open-label, Single-dose, Three Period Study to Determine the Pharmacokinetic Parameters of Hexaminolevulinate (HAL) Hydrochloride After Vaginal, Enema and Intravenous Administration of Healthy Female Volunteers [Completed]
The study will determine the extent of systemic absorption of HAL following vaginal and enema administration compared to intravenous administration to healthy female volunteers. In addition, the pharmacokinetic parameters for the combined level of 14C labelled substances (sum of parent and possible metabolites)will be assessed. The safety and tolerability of HAL following vaginal, enema and intravenous administration to healthy female volunteers will be investigated.

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

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Page last updated: 2007-02-13

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