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PubMed1981

[Hypophyseal response to LH-RH test, following use of non-aromatisable androgen on women with normal menstruation cycle (author's transl)].

Women with normal menstruation cycle were followed up for the hypophyseal response to LH-RH tests, following application of a non-aromatisable androgen. The purpose was to check up a hypothesis according to which hyperandrogenism was in no causative relationship with anovulation. The LH-RH test was applied twice to ten women with transsexualism who had an ovulatory menstruation cycle, one of them being used for control and the other immediately following four-day application of non-aromatisable androgen Ultandren (fluoxymesterone), Ciba, in the early follicular maturation phase of the menstruation cycle. The dose was 40 mg per diem, with the route of administration being oral. Hypophyseal reaction was assessed through the difference between the original value and the maximum of FSH and LH rise (radio-immunological measurement), 45 minutes following intravenous injection of 100 micrograms of LH-RH. Assessment was based on the phase-t test. The average differences between gonadotrophin values in the control cycle, on the one hand, and in the cycle under the impact of fluoxymesterone, on the other, were verified by simple t-test and pairs test. -- Non-aromatisable androgen fluoxymesterone did not depress with significance the depletion of either gonadotrophin in the women treated. Hypophyseal reaction to the LH-RH test was not substantially influenced by increased levels of non-aromatisable androgen. These results are likely to reinforce the doubts of the authors in the presence of an unambiguous direct causative relationship between hyperandrogenism and anovulation.

Adolescent↗
PubMed1976

Steroids and hematopoiesis. II. The effect of steroids on in vitro erythroid colony growth: evidence for different target cells for different classes of steroids.

Androgenic steroids and their non-androgenic 5beta-H metabolites enhance the number of colonies of hemoglobin synthesizing cells grown from rat bone marrow in response to a standard (0.25 unit/ml) concentration of erythropoietin. The target cells for two steroids were found to be different. Cells influenced by the androgen, fluoxymesterone (fluoxy), resembled cells responding to erythropoietin in their cycle characteristics, as measured by tritiated thymidine suicide, and in their physical characteristics, as determined by velocity sedimentation gradient separation. Cells responding to etiocholanolone (etio) had a much lower tritiated thymidine suicide rate and different sedimentation velocities. Preincubation of marrow cells with etio for two hours was sufficient to enhance erythroid colony growth by 84%, whereas a similar incubation with fluoxy produced no increment. These studies demonstrate that different classes of steroids may influence in vitro erythropoiesis by acting on distinct populations of marrow cells. Fluoxymesterone appears to act through cells already committed to respond to erythropoietin, while etiocholanolone appears to act on a separate, perhaps more primitive population of marrow cells.

Animals↗
PubMed1984

Androgen receptor abnormalities in identical twins with oligospermia. Clinical and biochemical studies.

Identical twin brothers presented with oligospermia, small testes, normal male phenotypes, elevated serum luteinizing hormone levels, and normal or elevated serum testosterone levels. Both men had low to low-normal cytosol androgen receptor binding capacity in cultured fibroblasts from pubic skin biopsy specimens. Qualitative abnormalities of cellular androgen receptors were suggested by low-normal or low nuclear androgen uptake in fibroblasts from both brothers as well as abnormal thermolability and subnormal molybdate stabilization of androgen receptors from one brother. In vivo androgen sensitivity was assessed in one twin following administration of testosterone or the non-aromatizable androgen fluoxymesterone. Fluoxymesterone suppressed serum luteinizing hormone and serum testosterone/estradiol-binding globulin, and although testosterone suppressed both serum luteinizing hormone and serum follicle-stimulating hormone, the suppression of serum luteinizing hormone by testosterone was subnormal. Both subjects showed marked exaggeration of the serum 17-hydroxyprogesterone increase after administration of human chorionic gonadotropin, despite normal serum testosterone increases, suggesting a block in testicular 17,20-desmolase, which converts 17-hydroxyprogesterone to testosterone. These studies suggest that oligospermia and block of the enzyme 17,20-desmolase may be the earliest manifestations of androgen resistance, and the finding of the syndrome of oligospermia, normal male phenotype, and androgen receptor abnormalities in identical twins indicates a genetic etiology of this disorder.

17-alpha-Hydroxyprogesterone↗
PubMed1988

Re-treatment of aplastic anemia with antithymocyte globulin or antilymphocyte serum.

Twenty-two patients with aplastic anemia were treated with antilymphocyte serum or antithymocyte globulin at Vanderbilt University and affiliated hospitals from 1980 to 1986. The median age was 42 (eight to 73 years); the male:female ratio was 8:14. Nineteen patients had severe aplastic anemia, and three had moderate disease. Twenty patients received antilymphocyte serum initially while two patients received antithymocyte globulin. Fifteen patients received fluoxymesterone 10 mg by mouth three times a day with antilymphocyte serum, and all received prednisone during the course of antilymphocyte serum or antithymocyte globulin. There were seven responses (31.8 percent) to the first course with four complete responses and three partial responses. Six of 15 patients who received fluoxymesterone showed a response, compared with zero of five treated without androgens (p less than 0.05). Eight patients with no initial response and a patient who experienced a relapse after a complete response were re-treated with either antithymocyte globulin (six) or antilymphocyte serum (three), with four of nine patients (44 percent) having a response (three complete responses, one partial response). Overall, 10 of 22 patients (45 percent) had a response (six complete responses, four partial responses). Median survival for those without a response is six months. Median survival for those with a response has not been reached, with follow-up ranging from 18 to 70 months. This study shows the benefit of a second cycle of antilymphocyte serum or antithymocyte globulin and a possible role for concomitant androgens in this treatment of aplastic anemia.

Adult↗
PubMed1983

Effect of low-dose androgen and zinc sulfate on sperm motility and seminal zinc levels in infertile men.

Beneficial effects of zinc therapy in some infertile patients with low seminal zinc concentrations and decreased sperm motility have been reported recently. The effects of zinc therapy, low-dose (5-10 mg/day) androgen therapy, and combination therapy of both zinc and low-dose androgen, on sperm motility and seminal zinc concentration were studied in patients referred to the andrology clinic. Low-dose androgen therapy increased seminal zinc concentrations and sperm motility, only when pretreatment seminal zinc concentrations were low. Furthermore, patients with low seminal zinc concentrations and poor sperm motility showed greater improvement of sperm motility and seminal zinc levels in response to zinc sulfate with fluoxymesterone than did fluoxymesterone alone or zinc sulfate alone, possible due to a synergistic effect of zinc and androgen.

Fluoxymesterone↗
PubMed1986

Androgen priming and response to chemotherapy in advanced prostatic cancer.

A total of 67 patients with progressive stage D2 prostatic cancer refractory to orchiectomy was entered in a controlled clinical trial to test whether androgen priming enhances the efficacy of cytotoxic drugs. All patients were treated continuously with aminoglutethimide and hydrocortisone to lower adrenal androgen secretion and were given cyclic intravenous chemotherapy. In addition, the 34 patients randomized to the stimulation arm received fluoxymesterone for 3 days before and on the day of chemotherapy. There was 33 controls. The median duration of followup was 24 months. A modestly higher response rate (objective remission plus disease stabilization) was observed in the stimulation arm (85 versus 72 per cent, p less than 0.05) when the analysis was restricted to the evaluable patients. However, a larger fraction of unevaluable patients was present in the stimulation group (41 versus 16 per cent), mostly as a result of toxicity from fluoxymesterone, which prompted early discontinuation of treatment. Thus, when data analysis included all patients the response rate actually was slightly higher in the control than in the stimulation arm (60 versus 50 per cent, p not significant). No difference was observed in median duration of response (9 months in both groups) or over-all survival. Our data suggest that at least in those patients with advanced disease androgen priming does not seem to enhance significantly the antitumor effect of the combination of amino-glutethimide and chemotherapy, and is associated with significant toxicity. These largely negative results may be explained by the large number of hormone-resistant cells present in tumors that have become refractory to orchiectomy.

Aged↗
PubMed1981

A comparison of androgens for anemia in patients on hemodialysis.

To compare the erythropoietic effects of nandrolone decanoate, testosterone enanthate, oxymetholone, and fluoxymesterone, we performed a randomized clinical trial in patients with anemia who were receiving maintenance hemodialysis (the women were not given testosterone enanthate). After a control period of at least two months, patients received one of the drugs for six months and then returned to control status; a second and third drug were administered in a similar fashion. Seventy-seven patients completed the first drug period, 56 the second, and 35 the third. The response to nandrolone and testosterone enanthate, the two drugs given by injection, was clearly superior to the response to oxymetholone or fluoxymesterone, given by mouth, in terms of the percentage of patients responding and the mean rise in hematocrit. Approximately half the patients had an increase of at least 5 percentage points in hematocrit after an injectable androgen was given; more than half the women responded. Patients who required transfusions regularly and those who had bilateral nephrectomies did not respond.

Administration, Oral↗
PubMed1991

Effect of anabolic steroids on mitochondria and sarcotubular system of skeletal muscle.

Soleus and extensor digitorum longus (EDL) mitochondria and sarcotubular system were examined in sedentary and trained (treadmill for 12 wk) male rats that were treated with fluoxymesterone or methandrostanolone (2 mg/kg, 5 days/wk, for 8 wk). Neither physical exercise nor anabolic/androgenic steroid administration resulted in a significant change in muscle wet weight. Treatment with the anabolizing androgens increased succinate dehydrogenase activity in fast-twitch muscle mitochondria; this effect was not enhanced by training and was not observed in soleus mitochondria. On the other hand, the content of the slow-twitch muscle in sarcotubular fraction was increased in sedentary rats by fluoxymesterone or methandrostanolone treatment, whereas no significant changes were found in EDL. The training program affected adenosinetriphosphatase (ATPase) activities in the sarcotubular fraction; Mg2(+)-ATPase was increased in both soleus and EDL, but Ca2(+)-ATPase was decreased only in soleus. However, in sedentary animals only the Mg2(+)-dependent activity of EDL was increased by anabolizing androgen treatment, and this change was not potentiated by additional training. The present data indicate that anabolic/androgenic steroids can affect mitochondrial and sarcotubular enzymes in skeletal muscle. The effects are muscle-type specific.

Anabolic Agents↗
PubMed1978

Effect of chronic administration of estrogen, androgen, or both on serum levels of gonadotropins in adult men.

Ethinyl estradiol (50 micrograms/day) or fluoxymesterone (10 or 20 mg/day), chosen because each is orally active and because fluoxymesterone is probably not converted to an estrogen, were given alone and in combination to adult men over several weeks. Measurements were made of serum FSH, LH, testosterone, and estradiol. The estrogen given alone suppressed serum FSH while the androgen given alone did not; however, the androgen may have enhanced the suppressive effect of the estrogen on the serum FSH. Neither steroid alone changed the serum LH but both together suppressed it. The estrogen alone decreased the serum testosterone, an effect probably mediated by the concomitant fall in serum FSH and a resulting decrease in sensitivity to the constant level of LH; a direct effect of estrogen on the testis seems less likely. The doses of estrogen and androgen used probably had a biologic effect equal to or somewhat above that of endogenously produced estrogen and androgen and thus reflected the maximum physiological effects of the endogenous steroids. Thus, in the chronic physiological control of FSH and LH in adult men, these data indicate that (1) testosterone alone, as an androgen, has little effect on FSH or LH, (2) estradiol (or total estrogen) has a greater suppressive effect on FSH than on LH and by its effect on FSH may indirectly regulate the secretion of testosterone, and (3) testosterone and estradiol together may be involved in the regulation of both FSH and LH.

Adult↗
PubMed1981

The relationship of androgen to the thyrotropin and prolactin responses to thyrotropin-releasing hormone in hypogonadal and normal men.

Fluoxymesterone, an androgen not converted to estrogen, caused a significant decrease in the TSH response to TRH in 11 men with primary hypogonadism [maximum change in TSH: before treatment, 11.3 +/- microU/ml (mean +/- SE); 8.9 +/- 1.0 after 2 weeks (P less than 0.001); 8.2 +/- 1.1 after 6 weeks (P less than 0.01)]. There was a significant fall in serum T4-binding globulin (TBG) (measured directly by RIA) without a change in the free T4 or free T3 index. Fluoxymesterone had no effect on the PRL response to TRH in hypogonadal men. The results suggest that 1) androgen per se is at least partly responsible for the lower TSH response to TRH in men compared to women and 2) androgen is not a cause of the lower PRL response to TRH in men.

Adult↗
PubMed1993

Effect of training and anabolic-androgenic steroids on drug metabolism in rat liver.

The effects of anabolic-androgenic steroid administration and exercise training on various aspects of hepatic function were investigated in sedentary and trained (treadmill for 12 wk) male and female rats treated orally with fluoxymesterone or methylandrostanolone (2 mg.kg-1 body weight, 5 d.wk-1 for 8 wk). The mean values of serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total and direct bilirubin, and total- and high-density lipoprotein-cholesterol remained within normal range in all groups of male animals. The same is true for female rats, except for an increase in alkaline phosphatase activity in the steroid-treated groups. Hepatic microsomal aniline p-hydroxylase activity was reduced in male and increased in female rats by either steroid, whereas no significant effect was detected on 7-ethoxycoumarin deethylase activity. The levels of cytochrome P-450 and cytochrome b5 were markedly decreased by the anabolic-androgenic steroid treatment in male rat microsomes, but neither the steroid administration nor exercise training induced significant changes in the cytochrome levels of female rat livers. Taking into account the significant increase in microsomal protein yield elicited by fluoxymesterone or methylandrostanolone treatment both in males and females, it is noteworthy that the total monooxygenase activities and cytochrome P-450 content, expressed on a per gram liver basis, were significantly increased in female whereas they were apparently unchanged in male rats. In conclusion, the present data show that the prolonged ingestion of high doses of anabolic-androgenic steroids, either with or without concurrent exercise training, can modify in a sex-dependent manner the capacity of rat liver to metabolize drugs without affecting classical serum indicators of hepatic function.

Alanine Transaminase↗
PubMed1975

Resolution of primary amyloidosis during chemotherapy. Studies in a patient with nephrotic syndrome.

A patient with primary amyloidosis with evidence for a plasma cell dyscrasia but no abnormal immunoglobulin components had nephrotic syndrome with severe renal impairment. Kidney and bone marrow had extensive amyloid infiltration. She was treated with penicillamine, malphalan, prednisone, and fluoxymesterone; through 6 months renal function gradually improved; urine protein excretion dropped dramatically, serum albumin rose; liver size decreased; the bone marrow returned towards normal. During the next 4 1/2 years melphalan, prednisone, and fluoxymesterone treatment was continued with further improvement in renal function to normal levels. The morphologic characteristics and cellular relations of amyloid fibrils in the bone marrow were studied before, during, and after successful chemotherapy; the findings are evidence for a dual role for the reticuloendothelial cell in the formation and destruction of primary amyloidosis. This patient's response suggests that a multi-agent chemotherapy approach should be further studied.

Adult↗
PubMed1984

Comparison of two long-term chemotherapy regimens, with or without agents to modify skeletal repair, in multiple myeloma.

A randomized controlled trial was initiated in 1972 to compare two chemotherapeutic regimens [1-3-bis (2-chloroethyl) 1-nitrosourea (BCNU), cyclophosphamide, and prednisone versus melphalan and prednisone], to determine whether the two regimens are cross-resistant, and to evaluate the effectiveness of sodium fluoride, vitamin D, calcium gluconate, and fluoxymesterone in the promotion of bone healing. Initial responses (50%) and survival (36 mo median) for patients treated with the two chemotherapeutic regimens were the same. Patients on either regimen who failed to respond after 6 mo had a very low response rate to the alternative regimen (approximately 10%). Initially responding patients were randomly assigned to either an active drug regimen (sodium fluoride, vitamin D, calcium gluconate, fluoxymesterone) or placebo tablets. There was no significant difference in the low percentage of patients demonstrating bone improvement. Thus, the BCNU, cyclophosphamide, prednisone regimen is as effective as melphalan and prednisone. Fluoride, calcium, vitamin D, and androgenic steroids should not be routinely recommended in myeloma, as they seem to add little to effective chemotherapy and may contribute to morbidity.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Partial filling micellar electrokinetic chromatography analysis of androgens and testosterone derivatives using two sequential pseudostationary phases.

Separation of anabolic and androgenic steroids by micellar electrokinetic chromatography (MEKC) has been little studied. Simultaneous separation of the endogenous alpha-epimers testosterone and epitestosterone has not been achieved with any electroseparation technique. Here, a partial filling micellar electrokinetic chromatographic (PF-MEKC) method is described for the analysis of three endogenous steroid hormones (androstenedione, testosterone, epitestosterone) and two synthetic anabolic steroids (fluoxymesterone, methyltestosterone). The resolution efficiency of single-isomer sulphated gamma-cyclodextrins and the surfactants sodium dodecyl sulphate and sodium taurocholate was exploited. The method is based on the sequential introduction of short plugs of two different pseudostationary phases into the capillary. The separation was completed in less than 10 min. The method can be used in quantitative analysis. Linear correlation was obtained between concentration and peak area of 0.996 or better. The repeatability (RSD) of the compound peak areas ranged from 3.6% (methyltestosterone) to 6.2% (androstenedione). Limits of detection were between 73 microg/L (testosterone) and 160 microg/L (fluoxymesterone). As a demonstration of the method, androstenedione, testosterone and epitestosterone were determined in a spiked urine sample.

Androgens↗
PubMed1977

Inhibitory effect of mepitiostane on the growth of mammary tumor of a rat.

Mepitiostane (2alpha,3alpha-epithio-5alpha-androstan-17beta-yl 1-methoxycyclopentyl ether) is an orally active anti-estrogenic and anabolic-androgenic steroid compound. Mepitiostane administered orally suppressed the growth of transplanted estrogen-dependent mammary tumor in rats. This result was compared with the oral administration of fluoxymesterone, which is widely used orally for treatment of advanced breast cancer. Experimental result showed that Mepitiostane has a more dominant antitumor activity than fluoxymesterone. Therefore, this new compound may be useful for clinical treatment of breast cancer.

Adenofibroma↗
PubMed1975

Treatment of myeloma. Comparison of melphalan, chlorambucil, and azathioprine.

A randomized study compared the response of patients with multiple myeloma to chlorambucil, melphalan, and azathioprine. All patients also received a combination of prednisone and fluoxymesterone. Seventy-three of 86 patients entered on the study could have evaluations. The results indicate that melphatan produced more responses than either azathioprine or chlorambucil, but responses to both of these agents were observed. No difference was noted between survival curves for patients with no poor-risk factors as compared to those having at least one poor-risk factor. The only poor-risk factor affecting survival in this group of patients was the blood urea nitrogen level.

Azathioprine↗
PubMed1992

A pilot trial of chemohormonal therapy for metastatic prostate carcinoma.

Fifteen patients with previously untreated metastatic prostate cancer were treated on a pilot trial with a combination of maximal androgen blockade plus intermittent cytotoxic therapy after androgen priming to stimulate cell division. Androgen blockage was carried out using a gonadotropin-releasing hormone analog (leuprolide) plus a nonsteroidal antiandrogen (flutamide). Carboplatin (CBDCA) (800 mg/m2) was given intravenously every 28 days, preceded for 3 days and followed for 3 days by androgen treatment with fluoxymesterone (5 mg orally twice a day), during which time flutamide was discontinued. Three patients (20%) achieved a complete response (CR), and eight patients (53.3%) achieved a partial response (PR). Four patients (26.7%) had stable disease (SD). The median progression-free survival (PFS) time was 31 months. Nine of 15 patients (60%) remain alive with a median follow-up time of 42+ months (range, 22 to 54 months). Grade 4 thrombocytopenia and Grades 3 or 4 leukopenia were experienced in 87% and 80% of patients, respectively, requiring dose reductions of CBDCA in 85% of the cycles. Six of 15 patients experienced a flare in bone pain with androgen priming. There were no associated spinal cord compressions; however, exclusion of impending spinal cord compression was required before entrance on study.

Adenocarcinoma↗
PubMed1988

Hemostatic effects of hormonal stimulation in patients with metastatic prostate cancer.

Hemostatic abnormalities are common in patients with metastatic malignancy and are attributed, in part, to materials secreted by tumor cells. Tumor stimulation might therefore cause further perturbation of hemostasis. This article reports observations on the effects of androgen stimulation on multiple hemostatic parameters in patients with metastatic prostate cancer. Testosterone was given before chemotherapy in an experimental protocol designed to increase tumor sensitivity to cytotoxic agents. The following parameters were measured on day 0 (before) and days 2 and 4 of fluoxymesterone administration: PT, APTT, platelet count, plasma betathromboglobulin (BTG), platelet factor 4 (PF4), fibrinogen, fibrin(ogen) split products (FSP), factor VIII coagulant activity (VIII C), von Willebrand factor antigen (vWF Ag), fibrinopeptide A (FPA), antithrombin III (AT III), and protein C antigen (PC). Ten patients were studied during 17 cycles of hormonal stimulation. Baseline levels of BTG, PF4, fibrinogen, FSP, factor VIII C, vWF Ag, and FPA were significantly elevated compared with normal control. Although androgen stimulation resulted in elevation of BTG, FPA, and FSP levels by day 4 in many patients, the changes for the entire group were not statistically significant. Other parameters remained unchanged or were only slightly elevated. Two patients developed laboratory evidence of disseminated intravascular coagulation (DIC) but were clinically unaffected. Our data suggest that most patients with metastatic prostate cancer show evidence of ongoing activation of platelets, coagulation, and fibrinolysis. In a few individual patients, androgen stimulation of this hormonally dependent tumor may cause further activation of platelets, coagulation, and fibrinolysis.

Aged↗