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PubMed1998

Cytokine involvement in cancer anorexia/cachexia: role of megestrol acetate and medroxyprogesterone acetate on cytokine downregulation and improvement of clinical symptoms.

The characteristic clinical picture of anorexia, tissue wasting, loss of body weight accompanied by a decrease in muscle mass and adipose tissue, and poor performance status that often precedes death has been named the cancer-related anorexia/cachexia syndrome (CACS). Chronic administration of pro-inflammatory cytokines, including interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor (TNF) either alone or in combination, is capable of reproducing the different features of CACS. High serum levels of these cytokines have been found in cancer patients, which seem to correlate with progression of the tumor. This paper describes a series of experimental and clinical studies demonstrating that: (1) high serum levels of some cytokines, including IL-1, IL-6, and TNF, are present in advanced-stage cancer patients, particularly those with CACS; (2) megestrol acetate (MA) has a beneficial therapeutic effect on CACS symptoms, such as appetite, body weight, and quality-of-life; (3) MA downregulates the synthesis and release of cytokines and relieves the symptoms of CACS; (4) cytokines play a key role in the onset of CACS; (5) medroxyprogesterone acetate (MPA) reduces the in vitro production of cytokines and serotonin (5-hydroxytryptamine, 5-HT) by peripheral blood mononuclear cells (PBMC) of cancer patients; and (6) MA and MPA reduce the cisplatin-induced 5-HT release in vitro from PBMC of cancer patients. Based on these results, a clinical study incorporating MA/MPA in combination with chemotherapy or chemoimmunotherapy may be warranted.

Anorexia↗
PubMed2006

The hormone replacement therapy drug tibolone acts very similar to medroxyprogesterone acetate in an estrogen-and progesterone-responsive endometrial cancer cell line.

Tibolone, a steroidogenic compound with both estrogenic and progestagenic properties, is used as an alternative for estrogen or estrogen plus progesterone hormone therapy for the treatment of symptoms associated with menopause and osteoporosis. We have evaluated whether the effect of tibolone on a human endometrial cell line is similar to, or comparable with, the effect of estradiol (E(2)), medroxyprogesterone acetate (MPA) or E(2) + MPA treatment. Using stable transfection techniques, the estrogen receptor (ER) expressing human endometrial cancer cell line, ECC1, was altered to also express both progesterone receptors (PRs). These cells were then used to assess growth regulation and expression profiling (Affymetrix U133plus2) under the influence of E(2) (1 nM), MPA (1 nM), E(2) + MPA or tibolone (100 nM). Growth assessment and comparison of profiles indicate that tibolone behaves predominantly like MPA. Furthermore, regulation of prereplication complex genes, such as the minichromosome maintenance genes, could be involved in the observed strong inhibition of growth by tibolone as well as MPA. In addition, in total, 15 genes were found to be specific for tibolone treatment. These genes were predominantly involved in regulation of the cell cycle and differentiation.

Cell Line, Tumor↗
PubMed2002

Depot medroxyprogesterone and bone mineral density.

OBJECTIVE: To investigate depot medroxyprogesterone (DMPA)-associated bone loss in a general practice setting. DESIGN: Forty-eight patients from a single practice who had used DMPA for contraception for more than 2 years. All patients had a serum oestradiol and if the serum level was <52 pmol/l or >52 pmol/l with menopausal symptoms, bone mineral densitometry (BMD) measurements were made at the lumbar spine (LS) and femoral neck (FN) using dual-energy x-ray absorptiometry (DEXA). Thirty-two patients had bone densitometry, of whom 27 had a serum oestradiol <52 pmol/l and five >52 pmol/l associated with menopausal symptoms. Of the remaining 16 patients, nine patients had a serum oestradiol <52 pmol/l but did not have a BMD as they moved away (five women) or switched to another contraceptive (four women). RESULTS: BMD results showed a significantly reduced bone mass at both sites with mean Z score LS -0.84 (95% CI -1.17 to -0.52) and FN -0.32 (95% CI -0.62 to -0.02). Eighteen women (56% of 32 women) had either osteopenia (15 cases) (T score < -1.0) or osteoporosis (three cases) (T score < -2.5) at the LS. There were trends to an association of a family history of height loss or tobacco smoking (current or past) for LS and FN Z scores that did not quite achieve significance. There was also a trend to lower body weight in those with a possible family history of osteoporosis or who were smokers and an inverse correlation of weight with BMD at the FN (p < 0.05) and a non-significant inverse correlation at the LS. CONCLUSION: The present results demonstrate that a low bone mass should be considered in patients with prolonged DMPA usage especially if they have risk factors for osteoporosis.

Absorptiometry, Photon↗
PubMed1995

Effects of medroxyprogesterone acetate and beta-estradiol on interleukin-6 production from osteoblasts and bone marrow macrophages of Wistar rats of different ages.

Using 18-week-old and 52-week-old Wistar rats, we examined interleukin-6 (IL-6) production from osteoblasts and bone marrow macrophages treated with medroxyprogesterone acetate (MPA) and/or beta-estradiol. The level of IL-6 production by osteoblasts was increased by treatment with MPA and, reversely, decreased by treatment with beta-estradiol. These changes were especially remarkable in osteoblasts of 52-week-old rats. Additionally, and in contrast, the production of IL-6 by bone marrow macrophages was not significantly changed by treatment with both agents. These data suggest that because the increased production of IL-6 by osteoblasts treated with MPA in opposition with beta-estradiol, MPA should be careful for osteoporosis dependent upon osteoclasts activated by IL-6. Finally, there was a marked difference in the amount of IL-6 produced between osteoblasts and bone marrow macrophages.

Aging↗
PubMed1996

Depot medroxyprogesterone acetate and breast cancer. A review of current knowledge.

Depot medroxyprogesterone acetate (DMPA) has been used worldwide since 1964 as a contraceptive and by 1993 was in use in more than 90 countries. It was licensed for contraceptive use in the US in 1992. One of the reasons for this delay in licensing in the US was the possibility of an increased risk of breast cancer associated with its use. A pooled analysis has recently been published, which brings together the data from 2 large studies of breast cancer risk associated with DMPA use. The overall results are reassuring, but there is some evidence of an increased risk of breast cancer associated with recent use of DMPA. There are substantial difficulties in interpreting this increase in risk. It is certainly possible that it may be the result of surveillance bias, although it could be a short term increase in risk that is not in fact sustained. The conclusion that DMPA should not be restricted as a contraceptive, provided that appropriate advice is given before use, is well-founded. However, further epidemiological work is needed on the long term effects of DMPA.

Breast Neoplasms↗
PubMed1981

Medroxyprogesterone acetate (MPA) plasma levels after oral and intramuscular administration in a long-term study.

In a long-term study (1 year) the plasma concentration of medroxyprogesterone acetate (MPA, Depo-Provera, Provera, Upjohn) was measured in 30 patients with endometrial carcinoma treated with MPA in the following dosages: 1) MPA 1 000 mg i.m. weekly; 2) MPA 1 000 mg i.m. once every second week, and; 3) MPA 100 mg orally twice daily. In the orally treated group the blood samples were taken just before the next tablet. The plasma concentration in the orally treated group rapidly reached steady state, while the i.m. treated group showed gradually increasing levels that had a tendency to level off after 6 months. The mean concentration at the end of the year was about three times higher for MPA 1000 mg i.m. weekly than for MPA 100 mg orally twice daily. This does not take into consideration the peak MPA level that occurs 2-4 hours after each tablet. MPA i.m. has a very good depot effect, with release of MPA from the injection site for up to 9 months. The steady initial increase in MPA plasma concentration seen in the i.m. treated groups is probably due to the additions of new depots rather than accumulation in the body generally.

Administration, Oral↗
PubMed1981

Pharmacokinetics of medroxyprogesterone acetate administered by oral and intramuscular route.

The present study was undertaken to elucidate: 1) The relationship between plasma concentration of medroxyprogesterone-acetate (MPA, ClinovirR, Depo Provera, Upjohn) administered both orally and intramuscularly. 2) The relation between dose and plasma concentration of MPA. Nineteen patients entered the study. In each patient the plasma concentration was monitored after the administration of a single oral and one intramuscular dose of MPA at the following dosage levels: 100 mg (5 patients), 400 mg (5 patients), 800 mg (5 patients) and 1 200 mg (4 patients). The interval between the oral and i.m. administration was 1 week. The results show: 1) A very large interindividual variation in plasma concentration. 2) An increase in plasma concentration after both oral i.m. dose. 3) After the i.m. administration, plasma levels remained steady or increased slightly throughout the test period. 4) After the oral administration the concentration increased rapidly to reach a peak by 2-7 hours, subsequently decreasing. Peak concentrations were 2-10 times higher than after i.m. administration. 5) Over the test period, the plasma concentration x time (0-168 h) is similar in the two modes of administration.

Administration, Oral↗
PubMed1982

Effect of oral medroxyprogesterone acetate on menopausal symptoms in patients with endometrial carcinoma.

A double-blind cross-over study was performed on 21 patients treated for endometrial carcinomas who had severe menopausal symptoms. The patients were randomized into two groups and received medroxyprogesterone acetate (MPA) 100 mg twice daily per os for 12 weeks and a placebo for 12 weeks. A significantly better effect on hot flushes and sweating was obtained with MPA than with the placebo. On average the maximum effect was achieved by MPA after 4-6 weeks. Six patients had a weight gain of more than 3 kg during the MPA administration, compared with none during the placebo administration. No significant difference was found in the blood pressure increase above 160/90 mmHg between MPA and placebo groups. Patients with endometrial carcinoma may risk exacerbation of their disease by undergoing therapy with exogenous estrogen. In contrast, MPA has been found of value in the treatment of disseminated endometrial carcinomas. In this study oral MPA was effective in the treatment of vasomotor menopausal symptoms and may be an alternative in women for whom estrogens might be hazardous.

Administration, Oral↗
PubMed1992

Long-term treatment with transcutaneous estradiol and oral medroxyprogesterone acetate.

In an open prospective study with therapeutic monitoring, 34 women with climacteric symptoms, FSH > 40 IU/L and LH > 25 IU/L were treated for 12 months with an estradiol-depot-patch (Estraderm TTS) 50 micrograms twice a week and medroxyprogesterone acetate 10 mg tablets from 12th to 25th day of cycle. During the first months a significant improvement was seen in hot flushes and other climacteric inconveniences in terms of Kupperman's menopause index. During the study period FSH and LH were suppressed and the estrogen values were normalized. The fraction of free estradiol compared to protein bound estradiol remained unchanged during the whole treatment. The serum-lipids and serum-SHBG at inclusion were within normal limits and did not change during 12 months of treatment. Thus from these parameters no sign of any liver induction was seen. Ten patients had short term skin symptoms while four withdrew from the study because of persistent skin symptoms. Nine patients withdrew from the study, in five cases this was related to the therapy while in the other four it was due to other causes. Twenty-five (74%) women wished to continue the treatment after 12 months.

Administration, Cutaneous↗
PubMed1994

Serum testosterone, androstenedione and luteinizing hormone levels after short-term medroxyprogesterone acetate treatment in women with polycystic ovarian disease.

BACKGROUND: Medroxyprogesterone acetate (MPA)-treatment suppresses serum gonadotropin and androgen concentrations in women with polycystic ovarian disease (PCOD). This study was designed to determine serum testosterone (T), androstenedione (A) and luteinizing hormone (LH) patterns in a group of oligomenorrheic PCOD patients after MPA-treatment. METHODS: The study group consisted of 11 women with ultrasonographically diagnosed PCOD. Blood samples were drawn in the morning in fasting conditions first during oligomenorrhea and then within one week after MPA-induced bleeding. After that the sampling was repeated four times at one week intervals. Student's paired t-test was used for statistical calculations. RESULTS: The levels of T, A and LH decreased significantly after MPA-treatment. During the follow-up the T and A concentrations increased significantly till the third sampling week, after which no further increases were found. CONCLUSIONS: Our results show that T and A secretion return to levels characteristic of PCOD after discontinuation of MPA-treatment within a few weeks in women with PCOD.

Adult↗
PubMed1996

The effects of estradiol valerate plus medroxyprogesterone acetate and conjugated estrogens plus medrogestone on climacteric symptoms and metabolic variables in perimenopausal women.

BACKGROUND: Two sequential hormone replacement regimens, containing either estradiol valerate plus medroxyprogesterone acetate (E2V/MPA) or conjugated estrogens plus medrogestone (CE/MED), were compared with respect to effects on climacteric symptoms, lipid metabolism, and hemostasis. METHODS: In an open, multicenter study, 51 perimenopausal women were randomized to E2V/MPA and 50 to CE/MED. Assessment of climacteric complaints was performed at baseline and at months 1, 3, and 6. The effects on lipid and hemostatic variables were measured at baseline and at month 6. Quantitative data were analyzed using analysis of variance, the paired t-test or the chi2 Mantel-Hanszel test, where appropriate. RESILTS: Efficacy regarding treatment of climacteric symptoms was with E2V/MPA as good as with CE/MED, with a statistically significant reduction of most symptoms in both groups. After 6 months, total cholesterol and triglycerides had remained unchanged in both groups. High-density lipoprotein cholesterol showed no significant change with E2V/MPA, whereas an increase was noted in the CE/MED group (p<0.05). Low-density lipoprotein cholesterol was decreased with E2V/MPA (p<0.01) and was unchanged in the CE/MED group. Hemostatic parameters showed no significant changes after 6 months, with the exception of a decreased prothrombin time with E2V/MPA (p<0.05). Acceptability was excellent, expressed by the low incidence of treatment-related drop-outs in both groups. CONCLUSIONS: E2V/MPA is a one tablet per day sequential HRT regimen, which is as effective and acceptable as hormone replacement therapy with CE/MED regarding treatment of climacteric symptoms. Neither preparation had negative effects on lipid metabolism and hemostatic variables.

Adult↗
PubMed1995

Correlation of TGF-beta 1 expression with medroxyprogesterone acetate responsiveness in mouse mammary adenocarcinomas.

We investigated the expression of transforming growth factors beta 1 and alpha (TGF-beta 1, TGF-alpha) in hormone-responsive (MPA-R) and unresponsive (MPA-U) tumor lines obtained from medroxyprogesterone acetate (MPA)-induced mammary adenocarcinomas in BALB/c mice. The tumors were transplanted into MPA-treated and untreated mice. TGF-beta 1 gene expression was observed in the MPA-R lines growing in untreated animals, but not in MPA-treated mice. TGF-beta 1 mRNA was not detected in the MPA-U tumor lines growing in either MPA-treated or untreated animals. In MPA-R lines the levels of TGF-beta 1 expression were inversely correlated to growth rate. High-affinity TGF-beta 1 receptors were present in the MPA-R tumors. These results suggest that one of the mechanisms by which MPA exerts its proliferative effect on MPA-R tumor lines is inhibition of the expression of TGF-beta 1. Thus, the lack of expression of TGF-beta 1 in MPA-U tumors may be related to the acquisition of autonomous growth.

Adenocarcinoma↗
PubMed1991

Effects of prolonged administration of the 19-nor-testosterone derivatives norethindrone and norgestrel to female NZB/W mice: comparison with medroxyprogesterone and ethinyl estradiol.

To evaluate effects of commonly used progestational estrogenic contraceptive steroids in a hormone-responsive model of lupus, we treated female NZB/W mice before clinical disease (6 wks of age) and after onset of lupus (24 wks of age) with doses of hormones titered to suppress reproduction. We report efficacy of norethindrone (NE) and norgestrel (NG), progestins derived from 19-nor-testosterone, in delaying expression of anti-DNA antibodies. Mice implanted with NG at 24 wks of age had prolonged lifespans. In contrast, the hydroxyprogesterone derivative, medroxyprogesterone acetate (MP), did not affect autoimmune disease. These observations suggest that prolonged administration of 19-nor-testosterone derivatives, in small doses adequate to suppress reproduction, may have ameliorative effects in systemic lupus erythematosus. Mice receiving ethinyl estradiol (EE) plus courses of tetracycline to suppress cystitis had active anti-DNA responses. In 60% of EE-treated mice, however, early deaths resulted from malignant lymphomas and complications of obstructive uropathy. Estrogen toxicity, rather than accelerated lupus, was the major cause of death in NZB/W mice treated with EE.

Animals↗
PubMed1995

Effects of danazol and medroxyprogesterone acetate on estrogen-(estradiol and estriol) specific binding sites in rabbit uterus.

In rabbit uterus, the presence of separate specific binding sites for not only estradiol but also estriol has been proposed. These sites may be correlated with an antiestradiol effect. Therefore, this study was designed to investigate the effect of antiestrogenic agents such as danazol and medroxyprogesterone acetate (MPA), especially on the estriol binding sites. Danazol and MPA in combination with estradiol were administered subcutaneously to immature female rabbits daily for 10 days, and resulted in a significant (p < 0.05) decrease in uterine weight and estradiol binding sites in the uterus. Treatment with MPA significantly (p < 0.05) decreased the level of estriol binding sites, but treatment with danazol resulted in this to a minimal extent in the uterus primed by estradiol. MPA did not bind to estradiol and estriol binding sites, while danazol at a high concentration bound to estriol binding sites with some affinity, but not to estradiol binding sites in the uterine cytosol of estrogen-primed rabbits. These results suggest that within the antiproliferative effect of danazol and MPA (an antiestrogenic action on estrogen-stimulated uterine growth) there are likely to be specific differences between some of the possible mechanisms of danazol and MPA in their action at the estriol binding site.

Animals↗
PubMed1998

The effects of different doses of medroxyprogesterone acetate on serum lipids, lipoprotein levels and atherogenic index in the menopausal period.

The purpose of our study was to make a contribution to research in determining the least harmful progestogen dose for women who have not had their uterus removed. The study was an open comparative trial. The patients were consecutively assigned to two groups. The first group (n = 19) were given 0.625-mg conjugated equine estrogen plus 5-mg medroxyprogesterone acetate (MPA), and the second (n = 18) 0.625-mg conjugated equine estrogen plus 2.5-mg MPA. Serum total cholesterol (T-cholesterol), triglyceride, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) levels plus LDL-C/HDL-C values (atherogenic index) were measured before the study and again after 6 and 12 months. These values were compared with ANOVA and postANOVA tests (Scheffe) within the groups and with unpaired t-test between the two groups. The triglyceride serum levels in the first group were decreased in the 12th month compared to baseline levels. In addition, LDL-C/HDL-C values were significantly decreased in the 6th month, but these values slightly increased in the following 6 months. In the second group, T-cholesterol, triglyceride, LDL-C and atherogenic index were decreased in the 12th month when compared to baseline levels within the groups. This decrease was statistically significant (p < 0.05). There was no significant difference between the two groups (p > 0.05). Hormone replacement therapy with continuous 0.625-mg conjugated equine estrogen and 2.5-mg MPA had a better effect on lipid profiles than 0.625-mg conjugated equine estrogens and 5-mg MPA after 12 months of treatment.

Arteriosclerosis↗
PubMed1998

Hormonal treatment and psychological function during the menopausal transition: an evaluation of the effects of conjugated estrogens/cyclic medroxyprogesterone acetate.

OBJECTIVE: To investigate the effect of hormone treatment on psychosocial distress of women during the menopausal transition (aged 40-52 years, still menstruating and with minor symptoms), in a study carefully designed to reduce bias and placebo effect. METHODS: The study was randomized, controlled by placebo, blinded to the subject, investigators and biostatistician, crossed-over after 6 months, and evaluated by a 77-item questionnaire every month for 12 months. The medication tested was continuous conjugated estrogens (Premarin) and cyclic medroxyprogesterone acetate (Provera). RESULTS: Of an eligible 105 apparently healthy women, recruited by advertisement, 83 completed the questionnaires for the study. Randomization was successful. While there was a substantial variation over time in the change of scores for all the psychosocial outcomes, there was no significant difference between active and placebo treatment when order of treatment allocation was ignored. However, a strong and consistent effect of the order of treatment allocation for many of the scores was found; in particular, the effect of active treatment was substantially stronger when it was administered second. Positive effects of active treatment were found for the score for the overall symptom rating test (p < 0.009) and its components of depression and feeling of inadequacy (p = 0.011; p = 0.001, respectively). CONCLUSIONS: The use of hormones, given as a continuous estrogen and cyclic progestogen formulation after a formal calibration/run-in period, may have a beneficial effect on psychosocial distress experienced by women towards the end of their reproductive function.

Adult↗
PubMed1998

A 3-year study of prevention of postmenopausal bone loss: conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone.

The aim of this study was to investigate the effects of tibolone in the prevention of postmenopausal bone loss over 3 years, and to compare these with the effects of sequential hormone replacement therapy. Forty early postmenopausal women were randomized to a 21-day regimen of conjugated equine estrogens (CEE, Premarin) plus sequential medroxyprogesterone acetate (MPA, Prodafem), or tibolone (Livial) daily. In total, 36 women completed 12 months and were considered for the intent-to-treat analysis, 34 completed 24 months and 23 completed 36 months. Main drop-out reasons were: lost to follow-up (n = 9) and minor side-effects (n = 4). Bone mineral density was measured at baseline and after 6, 12, 24 and 36 months, using dual-energy X-ray absorptiometry at the lumbar spine and the upper femur (neck, trochanter, total hip). In both groups, bone loss was prevented. Treatment with tibolone demonstrated significant increases in bone density at the spine (+4.6%; p < 0.01), at the total hip (+3.2%; p < 0.01) and at the trochanter (+4.5%; p < 0.01), whereas the CEE/MPA group showed a non-significant increase of bone mineral density at the lumbar spine (+2.6%) but no increases at the hip. Between-group differences in bone mineral density changes were significant (p < 0.05) for the total hip and the trochanter at 36 months. This increase of bone mineral density was not accompanied by changes in insulin-like growth factor-I (IGF-I) or insulin-like growth factor binding protein-3 (IGFBP-3) in either group. Osteocalcin, alkaline phosphatase and urinary ratios of hydroxyproline/creatinine and calcium/creatinine significantly decreased in both groups. In conclusion, sequential CEE/MPA prevented cortical and trabecular bone loss, with a transient increase of bone mineral density only during the first 6 months. Tibolone not only prevented cortical and trabecular bone loss, but further increased bone mineral density at the lumbar spine and at the hip throughout the 3 years of treatment, suggesting a sustained positive effect on bone mass.

Absorptiometry, Photon↗
PubMed1998

Menopausal symptom control and side-effects on continuous estrone sulfate and three doses of medroxyprogesterone acetate. Ogen/Provera Study Group.

OBJECTIVES: To establish the optimum oral daily dose of micronized medroxyprogesterone acetate (MPA), given in combination with 1.25 mg of estrone sulfate for menopausal symptom control. METHODS: This multicenter, randomized, double-blind study was conducted on 568 postmenopausal women who were randomized to take estrone sulfate 1.25 mg daily with 2.5, 5.0 or 10 mg of MPA daily for 2 years. The number of vasomotor symptoms and the severity of mood swings, lethargy, vaginal dryness and loss of libido as well as side-effects were recorded in a diary. Blood pressure and weight were recorded at each 3-month visit. RESULTS: Vasomotor symptoms were reported by approximately 80% of subjects at month 1, 23% at month 3 but only 9% by month 24. Mood swings, lethargy and vaginal dryness improved rapidly in the initial 3 months of therapy. Decrease in libido had a slower response to therapy in all three treatment groups. Breast tenderness was the commonest side-effect with 22% of subjects complaining of this in the first 3 months of therapy, dropping to 13% by 6 months. Headache, depression, nausea, bloating and irritability showed a similar pattern of decline. There was no significant difference in the rate of decrease in menopausal symptoms or reported side-effects between the three treatment groups. There was a small but significant (p < 0.001) decrease in systolic and diastolic blood pressure over the study period. CONCLUSIONS: All three treatment regimens provide adequate symptom control. Side-effects decreased markedly after the first 3 months, with no significant difference between the treatment groups.

Adult↗