(Fluoxymesterone Tablets, USP)
ANDROXY™ (Fluoxymesterone Tablets, USP) contains fluoxymesterone, a synthetic androgen. The androgens are steroids that develop and maintain primary and secondary male sex characteristics. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone is a synthetic derivative of testosterone. In their active form, all drugs in the class have a 17-beta-hydroxy group. 17-alpha-alkylation and halogenation at position 9 (fluoxymesterone) increase the pharmacologic activity per unit weight compared to testosterone when given orally. Fluoxymesterone is a white or practically white odorless, crystalline powder, melting at about 240°C with some decomposition. It is practically insoluble in water, sparingly soluble in alcohol and slightly soluble in chloroform.
ANDROXY™ Tablets are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired) —Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.
Hypogonadotropic hypogonadism (congenital or acquired) —Idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)
If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
Delayed puberty — ANDROXY™ (Fluoxymesterone Tablets, USP) may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers (see WARNINGS).
Metastatic mammary cancer — ANDROXY™ (Fluoxymesterone Tablets, USP) may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.
Published Studies Related to Androxy (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.
Combined endocrine treatment of elderly postmenopausal patients with metastatic breast cancer. A randomized trial of tamoxifen vs. tamoxifen + aminoglutethimide and hydrocortisone and tamoxifen + fluoxymesterone in women above 65 years of age. [2000.05]
The efficacy of combined endocrine therapy with tamoxifen (TAM), aminoglutethimide (AG), and hydrocortisone (H) or tamoxifen and fluoxymesterone (FLU) was evaluated against treatment with tamoxifen alone in 311 patients above 65 years of age with a first recurrence of a metastatic breast cancer.
Randomized comparison of megestrol acetate versus dexamethasone versus fluoxymesterone for the treatment of cancer anorexia/cachexia. [1999.10]
PURPOSE: Previous double-blind, placebo-controlled, randomized clinical trials have demonstrated that both corticosteroids and progestational agents do partially alleviate cancer anorexia/cachexia. Pilot information suggested that an anabolic corticosteroid might also improve appetite in patients with cancer anorexia/cachexia. The current trial was developed to compare and contrast a progestational agent, a corticosteroid, and an anabolic corticosteroid for the treatment of cancer anorexia/cachexia... CONCLUSION: Whereas fluoxymesterone clearly seems to be an inferior choice for treating cancer anorexia/cachexia, megestrol acetate and dexamethasone have similar appetite stimulating efficacy but differing toxicity profiles.
Combination hormonal therapy with tamoxifen plus fluoxymesterone versus tamoxifen alone in postmenopausal women with metastatic breast cancer. An updated analysis. [1991.02.15]
A randomized trial was performed to determine if therapy with tamoxifen (TAM) plus fluoxymesterone (FLU) was more efficacious than TAM alone for postmenopausal women with metastatic breast cancer... Although these data require confirmation in a prospective randomized trial, they suggest that there is a substantive therapeutic advantage for TAM plus FLU over TAM alone in elderly women with ER of 10 fmol or greater.
Tamoxifen and fluoxymesterone versus tamoxifen and danazol in metastatic breast cancer--a randomized study. [1988.09]
A prospective randomized trial of tamoxifen and fluoxymesterone versus tamoxifen and danazol in metastatic breast cancer was conducted from December 1980 to September 1985. Patients were eligible regardless of site of disease, estrogen receptor status, or age... We conclude that the response rates to the combinations of tamoxifen and fluoxymesterone or tamoxifen and danazol reported are equivalent in this study but that the increased toxicity with tamoxifen and fluoxymesterone would make tamoxifen and danazol the treatment of choice if a combination were to be used.
Clinical Trials Related to Androxy (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]
1. HAL- RAR causes a lower immediate postoperative pain compared with erxcision
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.
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.
1. Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling
or prolapse) that are eligible for surgical treatment with both methods.
1. Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure,
perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal
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
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.
Page last updated: 2007-05-03