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PubMed1975

Effects of synthetic androgen fluoxymesterone on triglyceride secretion rates in the rat.

Fluoxymesterone, a C-17 methylated derivative of testosterone employed in the treatment of renal-failure patients with refractory anemia, was administered to Sprague-Dawley rats and the effects on plasma triglyceride (TG) and immunoreactive insulin (IRI) levels and the rate of hepatic triglyceride secretion (TGSR) into plasma determined (Triton). Animals treated with fluoxymesterone demonstrated significantly lower TG (less than 0.05) and no alteration in TGSR. These findings are consistent with other observations which suggest that the triglyceride-lowering effect of androgens results from an accelerated rate of removal of triglyceride-rich lipoproteins from plasma.

Animals↗
PubMed1979

Growth increments with low dose intermittent growth hormone and fluoxymesterone in first year of therapy in hypopituitarism.

The availability of a commercial preparation of human growth hormone (hGH) prompted a study in children with hypopituitarism to determine the efficacy of a lower dose of hGH. Thirteen children, ages 4 years 3 months to 13 years 7 months, were given hGH concomitant with fluoxymesterone in an intermittent regimen. The hGH was given intramuscularly, 1 IU daily for 12 to 36 days in each course. There were four courses per year. The fluoxymesterone was given orally, 1 to 2 mg. The total amount of hGH administered was between 48 and 112 IU per year, as compared with the regimen of 312 IU per year, 2 units three times a week. The growth velocity in all 13 children improved, and the mean growth velocity was 6.4 cm +/- 1.13 SD. The mean bone age increment was 0.57 years +/- 0.14 SEM in one chronological year of therapy. The low dose regimen permits a significant reduction in cost of hGH without causing undue advance in bone age.

Adolescent↗
PubMed1989

[A case of Kennedy-Alter-Sung syndrome associated with external ophthalmoplegia--therapeutic efficacy of fluoxymesterone].

We reported a case with Kennedy-Alter-Sung syndrome (KAS) associated with bilateral external ophthalmoplegia. The patient had movement disturbance of bilateral infra-oblique muscles. The doll's eye phenomenon was not noted. It was suggested that the external ophthalmoplegia was due to the involvement of the oculomotor nucleus that innervated infra-oblique muscle. The serum levels of testosterone and gonadotropin were high, suggesting that the feminization of KAS patients was caused by androgen insensitivity. The feminization of KAS patients is similar to the incomplete form of testicular feminization syndrome except that they do not have feminization of genitals. Therefore, we proposed that abnormalities of androgen receptors might play a role in the pathogenesis of KAS. Fluoxymesterone therapy significantly improved the muscle weakness of the extremities of the patient, even though the therapeutic efficacy was shown temporarily. The therapeutic efficacy of fluoxymesterone for muscle weakness supports our hypothesis.

Androgen-Insensitivity Syndrome↗
PubMed1976

[Rise in serum creatinine under the androgen fluoxymesterone in chronic renal disease (author's transl)].

Eight men with chronic renal disease in the stage of compensated retention were given high doses of the androgen fluoxymesterone (40 mg/m2/day) for erythropoietin stimulation for 4 weeks. Seven of them showed a transient significant average rise in the serum creatinine level of 3.8 to 6.1 mg% which partly regressed only 8 to 12 weeks after stopping the medication. The rise in serum creatinine which appears under fluoxymesterone is attributable to a transient increase in the renal excretory function disturbance and/or a raised catabolism. Warning should be given against the further use of this drug in the treatment of renal anemia.

Adult↗
PubMed1977

Antitumor effect of two oral steroids, mepitiostane and fluoxymesterone, on a pregnancy-dependent mouse mammary tumor (TPDMT-4).

Pregnancy-dependent TPDMT-4 mammary tumors, characterized by requiring estrogen, progesterone, and pituitary hormones for growth, grew continuously in female DDD mice carrying pituitary isografts. The experimental model was used to investigate the antitumor effects of two p.o. steroids, mepitiostane and fluoxymesterone. When tumors implanted with pituitary isografts into the fat-pad reached palpable size, animals received 6 doses/week of 0.1, 0.3, 1.0, and 3.0 mg of either steroid intragastrically. Mepitiostane significantly suppressed tumor growth with regression in 25 and 29 percent of animals at 1.0 and 3.0 mg, respectively, but had no inhibitory effects at other doses. Fluoxymesterone retarted tumor growth during the first week of treatment at 3.0 mg but finally had no inhibitory effects at any doses. Under similar conditions ovariectomy caused tumor regression immediately, and epitiostanol, the parent steroid of mepitiostane, significantly suppressed tumor growth when given in 3 injections/week of 0.5 mg s.c. Tumous had papillary structures and almost lacked secretory activity. A comparison of these findings to those obtained with earlier generations suggests that TPDMT-4 tumors became less sensitive to the antitumor effect of epitiostanol and were able to grow at lower hormone levels with succeeding generations. Morphologically, progression to more cancer and less secretory activity was noticed.

Androstanes↗
PubMed1991

Combination hormonal therapy with tamoxifen plus fluoxymesterone versus tamoxifen alone in postmenopausal women with metastatic breast cancer. An updated analysis.

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. Patients failing TAM could subsequently receive FLU. The dose of both drugs was 10 mg orally twice daily. Objective responses were seen in 50 of 119 (42%) TAM patients and 64 of 119 (54%) TAM plus FLU patients (two-sided P = 0.07). Time to disease progression was better for TAM plus FLU (medians: 11.6 versus 6.5 months; Cox model, P = 0.03). Duration of response and survival were similar in the two treatment arms. Among 97 patients with estrogen receptor (ER) of 10 or greater and 65 years of age or older, there were highly significant advantages for treatment with TAM plus FLU in both response rate and time to progression. Of particular note is that in this patient group TAM plus FLU showed a survival advantage (Cox model, P = 0.05). 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.

Adult↗
PubMed1978

Determination of fluoxymesterone, norethandrolone, prednisolone, and prednisone in tablets by differential pulse polarography.

A differential pulse polarographic method for the determination of fluoxymesterone, norethandrolone, prednisolone, and prednisone in tablets is described. This method is more sensitive than dc polarography, and the measurement of diffusion current is greatly simplified. Sørensen phosphate buffer, pH 5.6, was used as the supporting electrolyte. No apparent interference was observed from tablet excipients; the method is rapid, simple, and relatively precise.

Fluoxymesterone↗
PubMed1977

[Erythropoietin in serum and urine in man upon hypoxic stimulation and hypoxic stimulation after pretreatment with fluoxymesterone (author's transl)].

The effect of the androgen fluoxymesterone (Flu) upon the hypoxic stimulus of erythropoietin (ESF) production was studied in 8 male and 3 female normal human subjects. After 4 weeks Flu pretreatment (40 mg/day/m2 body surface in men and 10 mg in women) hypoxic stimulation corresponding a maximum of 4000 m altitude was employed. After Flu pretreatment serum ESF titers increased by 80%, ESF excretion by 490%, and ESF clearance by 200% compared to hypoxic stimulation alone. The increase in serum ESF titers after Flu plus hypoxic stimulation employing only 25% of the Flu dose in females was higher than in males. ESF excretion, however, was lower in females than in males. Whereas Flu causes a marked increase in ESF production, ESF clearance is even more enhanced. As in the case of other serum proteins not only glomerular filtration, but also tubular processes may be involved in the excretion of ESF. Since results are available after a short term experiment of 24 h the double stimulation (androgen + hypoxia) may be recommended for clinical trials in men testing the ESF stimulating effect of androgens and anabolic hormones.

Adult↗
PubMed1978

[Erythropoietin in serum and urine in healthy persons and patients with chronic renal disease upon hypoxic stimulation and hypoxic stimulation after pretreatment with fluoxymesterone (author's transl)].

The question of a latent erythropoietin (ESF)-deficiency was studied in incipient renal anemia using a double stimulation technique for ESF. After a 4-week stimulation of ESF production with oral administration of fluoxymesterone (flu) intermittent hypoxic ESF stimulation was performed corresponding to a maximum altitude of 4000 m in 7 patients with chronic renal disease without or with incipient renal anemia (mean hematocrit 40%) and in 11 normal subjects (mean hematocrit 46%). Double stimulation in patients was compared with hypoxic stimulation alone and both were compared with controls. After flu alone only ESF excretion was increased in patients and in normal subjects. After flu plus 10 h of hypoxia serum ESF--titers were higher in healthy subjects than in the patients. The mean ESF titer after double stimulation was 81 mU/ml in patients and 115 mU/ml in normal persons. Forty-eight hour ESF excretion was 11 U and 43 U respectively. Compared to hypoxic stimulation alone double stimulation increased serum ESF titers in patients by 5% versus 80% in controls. Correspondingly, ESF excretion was enhanced by 19% and 49%, respectively. Finally, renal ESF clearance was increased by 42% versus 200%. After hypoxia alone non-anemic patients had higher serum ESF titers than healthy controls excluding a latent ESF deficiency in incipient renal anemia. It is concluded that decreased ESF production after double stimulation in patients was due to a nephrotoxic effect of flu followed by a decreased excretory and ESF-producing function of the damaged kidneys.

Adult↗
PubMed1986

Fluoxymesterone stimulation of tumor marker secretion in patients with breast carcinoma.

The gross cystic disease fluid protein of 15,000 MW (GCDFP-15) has been demonstrated to be a circulating glycoprotein tumor marker for breast carcinoma in approximately 40% of patients with advanced disease. A recent retrospective analysis of plasma GCDFP-15 levels in patients with advanced breast cancer suggested that androgen therapy could cause significant increases in plasma levels in the absence of disease progression. In order to evaluate the frequency, time course, and intensity of the androgen effect on GCDFP-15 production, a prospective study was initiated. Twenty-nine patients with stage IV breast carcinoma were treated with fluoxymesterone (20 or 30 mg/d). Plasma levels of GCDFP-15 and carcinoembryonic antigen (CEA) were measured by radioimmunoassay before and at various times during therapy. By day 6 of therapy, plasma GCDFP-15 had increased significantly (p = 0.03) from a mean basal level of 58 +/- 12 ng/ml to 160 +/- 60 ng/ml. By contrast, the mean CEA levels in the same patients increased only from 36 +/- 14 ng/ml. The distribution of percent increases in plasma GCDFP-15 was not uniform, but patients with high (greater than 82 ng/ml) basal levels had marked (greater than or equal to 75%) increases in 6/6 (100%) cases, whereas patients with low (less than 30 ng/ml) basal levels had similar increases in only 2/15 (13%) cases. Urinary excretion of GCDFP-15 usually paralleled the increases in plasma levels of the glycoprotein during the first six days of therapy. A linear correlation between percent change in plasma and percent change in urinary GCDFP-15 was demonstrated. A permanent cell line of human breast carcinoma, T47-D, was stimulated to secrete GCDFP-15 in vitro by androgen, but not by estrogen. From these data, we conclude that androgens can specifically stimulate secretion of GCDFP-15 by breast carcinoma tissue in most patients with elevated plasma levels of GCDFP-15, and in some patients with normal levels. The stimulation occurs within days and is not associated with clinical signs of tumor growth.

Apolipoproteins↗
PubMed2006

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.

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. PATIENTS AND METHODS: Postmenopausal women with early stage breast cancer that was known to be estrogen receptor (ER) positive were randomized to treatment with Tam (20 mg per day orally for 5 years) alone or combined with Flu (10 mg orally twice per day for 1 year). The primary endpoint was relapse-free survival (RFS) defined as local-regional or distant recurrence including ductal carcinoma in situ of the ipsilateral, but not contralateral breast, and death from any cause. RESULTS: There were 541 eligible patients entered between 1991 and 1995 and the treatment arms were balanced with respect to patient characteristics. The median follow up of patients still alive was 11.4 years. No significant difference was found between Tam plus Flu and Tam alone in terms of RFS or overall survival. The adjusted hazard ratio (Tam+Flu/Tam) for relapse or death without relapse was estimated to be 0.84 (95% CI: 0.64-1.10) and that for death was 0.89 (95% CI: 0.67-1.18). As expected there was more virilization in women who received Flu. 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.

Adult↗
PubMed1990

Testing for fluoxymesterone (Halotestin) administration to man: identification of urinary metabolites by gas chromatography-mass spectrometry.

Fluoxymesterone, an anabolic steroid, is metabolized in man primarily by 6 beta-hydroxylation, 4-ene-reduction, 3-keto-reduction, and 11-hydroxy-oxidation. These pathways of metabolism are suggested by the positive identification of 4 metabolites and the tentative identification of 3 other metabolites. Detection of the drug in urine is possible for at least 5 days after a single 10 mg oral dose to previously untreated adult males, by monitoring the presence of 2 metabolites, since the parent drug is not detectable more than 1 day after the dose.

Adult↗
PubMed1987

A randomized phase II trial of aminoglutethimide and hydrocortisone versus combined aminoglutethimide, hydrocortisone and fluoxymesterone in advanced breast cancer.

Fifty postmenopausal women with advanced breast cancer were included in the following randomized phase II trial: 25 patients received aminoglutethimide 1000 mg and hydrocortisone 40 mg daily. Twenty-five patients received aminoglutethimide 1000 mg, hydrocortisone 40 mg and fluoxymesterone 20 mg daily. The two groups of patients were comparable in respect to the most important pretreatment characteristics. The majority of patients in both groups had bone lesions. There was a history of response to tamoxifen in all the cases and 17 patients had positive estrogen and progesterone receptors. The evaluation of response was based on the system adopted by the UICC. In the aminoglutethimide-hydrocortisone group, 16 (64%) patients obtained a partial remission, 3 (12%) remained stable and 6 (24%) had progressive disease. In the combination treatment group, 17 (68%) patients obtained a partial remission, 3 (12%) remained stable and 5 (20%) developed progressive disease. The median duration of partial remission and stabilization of the disease was 9 and 7 months respectively in both groups.

Adult↗
PubMed1997

Biotransformation of 17-alkyl steroids in the equine: high-performance liquid chromatography-mass spectrometric and gas chromatography-mass spectrometric analysis of fluoxymesterone metabolites in urine samples.

In this study the equine metabolism of fluoxymesterone (9alpha-fluoro-11beta-17beta-dihydroxy-17alpha-meth ylandrost-4-ene-3-one) given orally has been investigated. The parent material was not detected, but two major 16-hydroxy metabolites which corresponded to a mono- and a di-hydroxylation product were evident. One of the hydroxylation positions was identified as C-16. Phase II metabolism in the form of glucuronide formation was also common. These steroids will provide target compounds for confirming abuse of this drug in the horse.

Anabolic Agents↗
PubMed2000

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.

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. A total of 279 patients were eligible. The response rates were assessed for 258 fully evaluable patients and were the following for the TAM (N = 94), the TAM+AG+H (N = 83), and the TAM+FLU (N = 81) groups, respectively, PR: 14, 18, and 21%, and CR: 20, 11, and 23%. The overall response rates are not statistically different (p = 0.30). The 95% CL of difference in response rates for TAM vs. TAM+AG+H are -9-19% and for TAM vs. TAM+FLU -4-25%. Time to treatment failure was comparable with median values of 9.2, 7.7, and 9.2 months in the TAM, TAM+AG+H, and TAM + FLU group, respectively (p = 0.17). The corresponding figures for survival are median times of 22.0, 24.1, and 21.1 months with a p-value of 0.62. Toxicity was more pronounced in both the combined treatment groups, and could in most instances be attributed to treatment with either AG+H or FLU. Currently, new specific aromatase inhibitors with lesser toxicity than AG are being evaluated in combination with TAM for treatment of primary and metastatic breast cancer. In conclusion, the simultaneous use of TAM and AG +H or FLU does not seem to improve the therapeutic efficacy in elderly postmenopausal patients with metastatic disease. So far, combined endocrine therapy in this group of patients should only be used in the context of clinical trials.

Aged↗
PubMed1982

Acceleration of delayed growth with fluoxymesterone.

61 boys with constitutional delay of growth and maturation, aged 9-19 years and with a bone age (BA) lag of 1.3-5.5 years, were administered fluoxymesterone (0.05-0.24 mg/kg daily orally, relative dose increasing with age) to accelerate growth. The therapy was continuous and lasted 0.4-3.6 years. The findings are compared with 37 observation periods in a similar group of untreated boys. Growth velocity increased in every treated boy during the therapy, the mean first-year increment being 4.3 +/- 1.6 cm/year. For most boys this brought about a decrease in the height difference from peers, and so afforded the psychosocial relief that was the objective of the therapy. After therapy the velocity decreased slightly in most boys, from a mean of 9.1 +/- 1.4 to 7.1 +/- 3.3 cm/year. The effect of the intervention on final height was assessed by three relatively independent methods of prediction. These were found to be equally valid in the 15 control boys for whom final heights are known. The effect appeared to vary individually, but on the average there appeared to be no loss of height potential. No individual boy with initial BA greater than 10.5 years showed a substantial reduction in predicted final height.

Adolescent↗
PubMed1988

Randomized clinical trial of tamoxifen alone or combined with fluoxymesterone in postmenopausal women with metastatic breast cancer.

A randomized clinical trial was performed to determine if combination hormonal therapy with tamoxifen (TAM) and fluoxymesterone (FLU) was more efficacious than TAM alone for the treatment of postmenopausal women with metastatic breast cancer. Patients failing TAM could subsequently receive FLU. The dose of both drugs was 10 mg orally twice daily. Objective responses were seen in 50 of 119 TAM patients (42%) and 63 of 119 TAM plus FLU patients (53%) (one-sided P = .05). Time to disease progression distributions were better for TAM plus FLU (median, 350 days v 199 days), but the log rank test only approached statistical significance (one-sided P = .07). Duration of response and survival distributions were similar between the two treatment arms. Toxicities, in terms of androgenic side effects, were greater on the TAM plus FLU regimen. Fifty-two patients are evaluable for response with FLU following TAM and 21 (40%) have achieved a response. We conclude that the advantages in terms of response rate and time to progression observed with TAM plus FLU probably represent a biological effect, but are not of sufficient magnitude to justify the routine clinical use of this combination given the lack of survival advantage and side effects encountered.

Adult↗
PubMed1987

Effect of fluoxymesterone therapy on semen quality in the treatment of subfertile men.

The use of androgen therapy to improve the poor quality of semen was assessed on 69 subfertile men. The men were treated with 2 or 4 mg of fluoxymesterone daily up to 12 months. During the course of treatment, the semen samples were analyzed every 3 months and the overall mean values for various semen characteristics were compared before and after the onset of treatment. The sperm motility and normal sperm morphology showed a significant improvement with treatment. Based on overall evaluation, androgen therapy may benefit some patients, while in others it may not significantly alter the semen quality.

Fluoxymesterone↗