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PubMed1987

On the role of additive hormone monotherapy with tamoxifen, medroxyprogesterone acetate and aminoglutethimide, in advanced breast cancer.

We analyzed the results of clinical studies on the therapeutic efficacy of hormone monotherapy with tamoxifen, medroxyprogesterone acetate, and aminoglutethimide in metastatic breast cancer, which were published between 1971 and 1986 and involved altogether 7000 patients. The overall response rates in patients treated with these hormonal single agents at various dose levels ranged from 31%-42%. When only estrogen receptor-positive patients were considered, the response rates lay between 41% and 54% in groups which were treated with the antiestrogenic agents tamoxifen or aminoglutethimide. The duration of remission was 12 months for tamoxifen- and aminoglutethimide-treated women, whereas medroxyprogesterone acetate effected remissions lasting from 6-16 months. The overall mean survival from start of therapy in tamoxifen- and aminoglutethimide-treated groups was 20 months, whereas information concerning this therapeutic parameter was available only in a minority of medroxyprogesterone acetate-treated groups. With respect to the response by site of metastatic lesions, all three agents caused a significantly higher degree of remissions in the soft tissue as compared to visceral disease.

Aminoglutethimide↗

PubMed1990

Influence of progestins on serum hormone levels in postmenopausal women with advanced breast cancer--II. A differential effect of megestrol acetate and medroxyprogesterone acetate on serum estrone sulfate and sex hormone binding globulin.

Serum estradiol, estrone, estrone sulfate and sex hormone binding globulin were measured in 10 postmenopausal patients with advanced breast cancer receiving sequential treatment with medroxyprogesterone acetate and megestrol acetate. Treatment with megestrol acetate caused a non-significant reduction in serum estradiol (mean reduction of 19%, 0.05 less than P less than 0.1) but significant reductions in serum estrone (mean reduction of 20%, P less than 0.02) and serum estrone sulfate (mean reduction of 54%, P less than 0.005) compared to treatment with medroxyprogesterone acetate. In contrast, treatment with medroxyprogesterone acetate reduced serum sex hormone binding globulin more compared to treatment with megestrol acetate (mean reduction of 69%, P less than 0.01). These findings suggest that the two progestins have differential effects on serum hormone levels. The finding that treatment with megestrol acetate causes a significant reduction in serum estrone sulfate level warrants further investigations of this potentially important mechanism of action of this drug in advanced breast cancer.

Aged↗

PubMed1988

Sequential use of conjugated estrogens and medroxyprogesterone in the climacteric syndrome: clinical and histological findings.

Seventy-four symptomatic postmenopausal women received conjugated equine estrogens, 0.625 mg daily, alternating 3 wk of treatment with 1 wk free. Medroxyprogesterone acetate, 10 mg daily, was added from day 12 to day 21 of the estrogen therapy. The length of treatment ranged between 36 and 50 mth (media 42.8). This sequential treatment appears to be an effective medication for menopausal women as 86.4% of patients showed a complete regression of symptoms. Its acceptability may be considered good since few side effects and low incidence of abandons (12.2%) were registered. Medroxyprogesterone seems to be a useful agent to counteract the possible cocarcinogenetic effect of conjugated estrogens on account of the high incidence of induced secretory endometrium obtained (92.2%), the reversal of six pretreatment endometrial hyperplasias and the absence of any premalignant endometrial lesion after at least 3 yr of this sequential treatment. The only case of endometrial cancer registered does not jeopardize this conclusion as was observed in a women who took medroxyprogesterone very irregularly.

Adult↗

PubMed1994

Plasma concentrations of medroxyprogesterone acetate, estradiol and estrone following oral administration of Klimaxil, Trisequence/Provera and Divina. A randomized, single-blind, triple cross-over bioavailability study in menopausal women.

The absorption of estradiol and medroxyprogesterone acetate was investigated in a randomized single-blind, triple cross-over study, in 12 menopausal women, for four different HRT drugs (Klimaxil, a combination tablet containing 17 beta-estradiol 2 mg and medroxy-progesterone acetate 5 mg; Divina, a combination tablet containing 17 beta-estradiol valerate 2 mg and medroxyprogesterone acetate 10 mg; Trisequence, a triphasic preparation containing 17 beta-estradiol 2 mg in the first phase; Provera, a tablet containing medroxyprogesterone acetate 5 mg). Trisequence and Provera were ingested simultaneously. In conclusion, there was no statistically significant difference between the drugs with respect to the estradiol levels. The estrone concentration, however, differed between the different drugs. The serum concentration was higher after intake of tablets containing estradiol than after intake of tablets containing the valerate ester. There was a significant increase in the MPA levels between periods 1 and 3. Finally, Divina produced higher MPA concentrations than Klimaxil and the combination of Trisequence and Provera, although the mean AUC was not twice as high, as might have been expected.

Administration, Oral↗

PubMed1989

Deoxyribonucleic acid content and medroxyprogesterone acetate treatment in metastatic renal cell carcinoma.

High dose medroxyprogesterone treatment was given to 20 patients with metastatic renal cell carcinoma. Distant metastases occurred before the perifascial nephrectomy in 11 patients and following nephrectomy in 9. Tumor deoxyribonucleic acid content was analyzed by flow cytometry in 8 fresh samples from each primary tumor. Four patients had homogeneously diploid primary tumors, 5 had tumors with diploid and aneuploid samples, and all 8 tumor samples were aneuploid in 10 patients. Deoxyribonucleic acid analysis was unsuccessful in 1 patient. One patient with a diploid primary tumor died of an intercurrent disease. Three patients (16 per cent) had objective remissions and 1 had a long-lasting stable disease. Of the 4 patients with any response to medroxyprogesterone acetate treatment 3 had diploid primary tumors, and 1 had 8 diploid and 2 aneuploid samples in the primary tumor. The remaining 14 patients showed no response to treatment and had progressive disease (11 of these patients died within 14 months). All 14 patients had aneuploid primary tumors. The results indicate that tumor ploidy might be related to response to medroxyprogesterone acetate treatment. Deoxyribonucleic acid content seems to be an important parameter to consider in planning treatment of metastatic renal cell carcinoma.

Aneuploidy↗

PubMed1987

Adjuvant medroxyprogesterone acetate to radical nephrectomy in renal cancer: 5-year results of a prospective randomized study.

From July 1, 1979 to June 30, 1983, 136 consecutive patients from 5 centers in Lombardy entered a prospective randomized study to compare 500 mg. adjuvant medroxyprogesterone acetate 3 times a week for 1 year to no treatment following radical nephrectomy for category M0 renal cancer. After a median followup of 5 years (range 42 to 90 months) 40 of 120 evaluable patients (33.3 per cent) experienced relapse after a median interval free of disease of 17 months (range 2 to 74 months). Relapses occurred in 19 of 58 evaluable patients in the adjuvant treatment group (32.7 per cent) and in 21 of the 62 evaluable controls (33.9 per cent). Sex steroid hormone receptors were studied in 102 of the 120 evaluable patients with the dextran-coated charcoal technique. No significant correlation could be found among receptors, relapses and treatment. On the other hand, 33 (56.9 per cent) of the 58 treated patients experienced 39 complications related to the long-term hormonal therapy. Three patients had to discontinue medroxyprogesterone acetate for severe toxicity after 2 to 3 months. Medroxyprogesterone acetate cannot be recommended as adjuvant therapy to radical nephrectomy in patients with renal cell carcinoma.

Adolescent↗

PubMed1986

Comparison of diethylstilbestrol, cyproterone acetate and medroxyprogesterone acetate in the treatment of advanced prostatic cancer: final analysis of a randomized phase III trial of the European Organization for Research on Treatment of Cancer Urological Group.

Patients with previously untreated category T3 to T4 Mo or Ml prostatic cancer were allocated randomly to receive 250 mg. cyproterone acetate per day, a loading dose of 500 mg. medroxyprogesterone acetate intramuscularly 3 times weekly for 8 weeks followed by 100 mg. orally twice daily, or 1 mg. diethylstilbestrol 3 times daily in a phase III trial (protocol 30761) performed by the genitourinary tract cooperative group of the European Organization for Research on the Treatment of Cancer. Of 236 patients entered 210 were eligible: 75 received cyproterone acetate, 71 medroxyprogesterone acetate and 64 diethylstilbestrol. Local and distant tumor response, time to progression, survival and toxicity were assessed. Patients treated with medroxyprogesterone acetate had a less favorable course with a shorter duration of survival and time to progression than those treated with the other 2 drugs. There was no significant difference between diethylstilbestrol and cyproterone acetate. Cardiovascular side effects were reported more often in patients treated with diethylstilbestrol than in those treated with cyproterone acetate but severe and lethal cardiovascular toxicity was relatively low in all groups. Other side effects were negligible. Further studies are required to establish the influence of effective hormonal treatment upon survival.

Aged↗

PubMed2026

Genomic hallmarks of depot medroxyprogesterone acetate-associated meningiomas.

BACKGROUND: Population-based studies have linked progestin exposure to increased meningioma risk. However, the molecular basis of meningiomas associated with depot medroxyprogesterone acetate (DMPA)-a common injectable contraceptive-remains undefined. METHODS: We performed an integrated clinicopathologic and genomic analysis of meningiomas from 10 women with long-term DMPA exposure. Tumors underwent histopathological analysis, targeted sequencing, and DNA methylation profiling. Data were integrated with reference cohorts (Baylor and Heidelberg) and analyzed through classifier assignment, consensus clustering, copy number analysis, differential methylation testing, and dimensionality reduction. RESULTS: Depot medroxyprogesterone acetate-associated meningiomas were all newly diagnosed, World Health Organization grade 1 tumors with a predilection for the anterior and central skull base (n = 6). Nine patients harbored multiple meningiomas. Four experienced regression of untreated meningiomas following DMPA cessation, while 5 demonstrated stabilization. Histopathology demonstrated relative overrepresentation of metaplastic morphology, an uncommon meningioma subtype. All DMPA-associated meningiomas mapped to benign molecular groups, and most exhibited low copy number alteration burden. Targeted sequencing revealed enrichment for TRAF7 mutations (n = 5), with no NF2 mutations detected. Eight tumors shared consensus cluster identity, with cohesive grouping on principal component analysis and t-distributed stochastic neighbor embedding. No differential methylation was identified at the progesterone receptor locus. CONCLUSIONS: Depot medroxyprogesterone acetate-associated meningiomas represent a recognizable phenotype within the broader NF2-wildtype/TRAF7-enriched spectrum of benign meningiomas, characterized by chromosomal stability, a shared methylation profile, tumor multiplicity, and regression or stabilization following DMPA cessation. While derived from a small single-institution cohort, these findings provide a molecular framework for understanding progestin-associated meningioma biology, reinterpreting epidemiologic literature, and informing population-level risk stratification.

Humans↗

PubMedDate not supplied

The effect of medroxyprogesterone acetate on gonadotropin secretion in girls with precocious puberty.

Plasma luteinizing hormone (LH) and follicle stimulating hormone (FSH) as detected by radioimmunoassay have been found to be present in prepubertal children and show a gradual rise until the onset of puberty. Children with idiopathic true precocious puberty have plasma gonadotropin levels which are appropriate for their advanced degree of sexual development. A potent progestational agent, 6-methyl-17-hydroxyprogesterone acetate or medroxyprogesterone has been used in the treatment of precocious puberty and will suppress its physical manifestations. In this study the effect of medroxyprogesterone on gonadotropin levels was investigated in seven girls with true precocious puberty. Plasma LH values were found to be significant lower in patients receiving this agent than in a group of normal prepubertal girls. FSH values did not differ from the control group. One patient was evaluated prior to treatment and showed decreasing levels of LH after therapy was begun. These data suggest that medroxyprogesterone may act on the pituitary-hypothalamic axis to suppress the pubertal levels of LH.

Adult↗

PubMed1999

Decline in bone mineral density with stress fractures in a woman on depot medroxyprogesterone acetate. A case report.

BACKGROUND: Depot medroxyprogesterone acetate is a popular contraceptive among young, physically active women. However, its administration has been linked to a relative decrease in estrogen levels. Since bone resorption is accelerated during hypoestrogenic states, there has been growing concern about the potential development of osteoporosis and fractures with the use of this contraceptive method. CASE: A physically active, 33-year-old woman demonstrated a 12.4% drop in femoral neck bone mineral density (BMD), 6.4% drop in lumbar BMD and 0.8% drop in total BMD with the subsequent development of a tibial stress fracture while on depot medroxyprogesterone acetate. Bone mineralization rapidly improved, and the stress fracture resolved with discontinuation of the medication. CONCLUSION: The long-term effects of depot medroxyprogesterone acetate on bone mineralization in physically active women should be evaluated more thoroughly.

Adult↗

PubMed1992

Direct effects of medroxyprogesterone acetate, danazol, and leuprolide acetate on endometrial stromal cell proliferation in vitro.

OBJECTIVE: To assess the direct effects of three endometriosis chemotherapeutic agents (medroxyprogesterone acetate [MPA], danazol, and leuprolide acetate [LA]) on endometrial cell proliferation. DESIGN: Analysis of cell proliferation in vitro. SETTING: Proliferative phase endometrial stromal cells isolated from biopsy specimens and grown in short-term culture served as a model for stromal components of endometriotic implants. PATIENTS: Biopsies obtained from volunteers with regular cycles and without endometriosis or endometrial pathology. INTERVENTIONS: Medroxyprogesterone acetate, danazol, and LA were added to nutrient media with the following supplements: 2.5% calf serum (CS) only; 2.5% CS+estradiol (E2) 110 pmol/L; 2.5% CS+E2 550 pmol/L; 10% preovulatory serum (net E2 624 pmol/L). MAIN OUTCOME MEASURES: Cumulative [3H]-thymidine incorporation as a reflection of cell proliferation. RESULTS: Medroxyprogesterone acetate and danazol exerted significant antiproliferative effects on stromal cell proliferation (P less than 0.05), effects that were enhanced by an absence of exogenous E2. Leuprolide acetate exerted no consistent effects. CONCLUSIONS: These data imply that MPA and danazol but not LA exert direct effects, suppressing growth of endometriotic implants.

Adult↗

PubMed1992

New trends in the use of medroxyprogesterone acetate as a chemotherapeutic agent in gynecologic malignancies.

In order to improve the results of hormonal therapy of gynecologic malignancies by means of medroxyprogesterone acetate two approaches are explored. In the first approach medroxyprogesterone dosage increased up to 400 mg a day, achieved better results in curative as well as adjuvant treatment of advanced or early gynecologic cancers. In the other approach, the combined, simultaneous or successive treatment by means of tamoxifen and medroxyprogesterone was even more successful for these therapeutic purposes compared to monohormonotherapy.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1990

The effect of low-oestrogen combined pill, progestogen-only pill and medroxyprogesterone acetate on oral glucose tolerance test.

The effect of a low-oestrogen combined pill, progestogen-only pill and medroxyprogesterone acetate on oral glucose tolerance test was studied in 29, 30 and 9 indigenous Kenyan women respectively. Glucose tolerance test was performed before treatment was started and then after 1,3 and 6 months in microgynon users. The mean areas under the glucose curves were also significantly elevated. Significant increase in blood glucose values were noted only at 30 minutes after 6 months of use of the progestogen-only oral contraceptive but the mean blood glucose values were higher than in the control after 1,3 and 6 months of use. However, the mean values of the areas under the glucose curves were significantly elevated after 1,3, and 6 months of use. Medroxyprogesterone acetate users showed significantly lower fasting blood glucose values at 60 and 90 minutes after 1 month of use, after which the blood glucose values returned to the pre-treatment values. The mean values of the glucose curve areas showed no significant change. It is concluded that both microgynon and minipill cause relative impairment of glucose tolerance test as early as after 1 month of use. Medroxyprogesterone acetate does not impair oral glucose tolerance for at least the first 6 months of use. The implications of these findings are discussed.

Adult↗

PubMed1988

Evaluation of oral medroxyprogesterone acetate in the treatment of endometriosis.

Medroxyprogesterone acetate was administered orally at the daily dose of 50 mg for four months to 21 symptomatic women with moderate to severe endometriosis, staged according to the American Fertility Society classification. The efficacy of the therapy was evaluated prospectively by the patients' symptomatology, monthly pelvic examinations, and by restaging the disease at second-look laparoscopy during the last week of treatment. The effects of therapy on the serum gonadotropin and ovarian steroid levels and on the endometrium and the implants of endometriosis were also evaluated. Improvement of symptoms, pelvic nodularity, and tenderness occurred in 80% of the patients. The mean stage score of disease by the American Fertility Society classification decreased from 18.2 +/- 2 before therapy to 5.9 +/- 1 after therapy (P less than .005). Amenorrhea, breakthrough bleeding, and persistent cyclic bleeding occurred in 75, 20, and 10% of the patients, respectively. Ovulation was inhibited in all patients, but serum hormone changes were statistically significant only for LH, which decreased from 9.5 +/- 4 to 5.2 +/- 2 IU/L (P less than .001), and estradiol (E2), which decreased from 80 +/- 30 to 46 +/- 26 pg/mL (P less than .02). Atrophic changes and pseudodecidualized reaction occurred in both the endometrium and the implants of endometriosis. In summary, oral medroxyprogesterone acetate is effective in relieving symptoms and objectively improving endometriosis. Besides inducing a pseudodecidualized reaction and atrophic changes in the endometrium and ectopic implants, medroxyprogesterone acetate also suppresses ovulation and the serum levels of both LH and E2.

Administration, Oral↗

PubMed1984

Depo-medroxyprogesterone acetate compared with conjugated estrogens for the treatment of postmenopausal women.

Forty-three women who had undergone a natural or surgical menopause were randomized to receive either 0.625 mg of conjugated estrogens or an intramuscular injection of 150 mg of depo-medroxyprogesterone acetate (DMPA) for 25 days each month. Vasomotor symptoms were recorded before treatment for three weeks and weekly thereafter for three months. Serum estradiol (E2) and estrone (E1) were measured before and during the second month of treatment, as were urinary calcium, hydroxyproline, and creatinine levels. Vasomotor symptoms decreased significantly in both groups, and this reduction was of a similar magnitude with either treatment. Whereas 18% of patients in both groups did not have a reduction in vasomotor symptoms, of those women who did benefit, vasomotor symptoms decreased 61.5 +/- 7.5% with conjugated estrogens and 69.4 +/- 7.7% with DMPA. Eighteen percent of patients treated with conjugated estrogens reported no vasomotor symptoms whatsoever, as compared with 33% among those treated with DMPA. Serum estrone and estradiol increased in patients receiving conjugated estrogens, but were lower in women treated with depo-medroxyprogesterone acetate. Urinary calcium/creatinine and hydroxyproline/creatinine ratios were significantly lowered to the premenopausal range in women treated with conjugated estrogens and DMPA. There were no differences in these ratios when the two treatments were compared. Adverse side effects such as vulvovaginal complaints and weight gain were negligible in both groups and the complaints of dyspareunia were similar. The data from this short-term study suggest that depo-medroxyprogesterone acetate affords a suitable alternative to estrogen therapy for reducing vasomotor symptoms and may prevent bone resorption as well.

Adult↗

PubMedDate not supplied

Treatment of renal carcinoma: a phase III randomized trial of oral medroxyprogesterone (Provera), hydroxyurea, and nafoxidine.

Seventy patients with metastatic renal carcinoma were randomized to receive hydroxyurea, nafoxidine, or medroxyprogesterone (Provera) orally. Sixty patients were considered evaluable, with a response rate of 5% for medroxyprogesterone (one complete remission) and hydroxyurea (one partial remission) and a response rate of 16% for nafoxidine (two complete remissions and one partial remission). Differences in response rates and duration of survival were not statistically significant. The major toxicity observed with hydroxyurea was hematologic, and the major toxic effect of nafoxidine was an ichthyosis-like skin rash. Toxicity for medroxyprogesterone was minimal.

Clinical Trials as Topic↗

PubMed1980

Endogenous serum testosterone in males after different doses and routes of administration of medroxyprogesterone acetate.

The effects of different doses and routes of administration (oral and IM) of medroxyprogesterone acetate on endogenous testosterone secretion were studied in healthy male volunteers. There were three treatment groups. Serum testosterone levels, measured by radioimmunoassay before, during and after different doses of medroxyprogesterone acetate, were significantly lowered (p < 0.05) in these subjects. A tendency to return toward pretreatment values was noted within three to six weeks after the last dose of medroxyprogesterone acetate. The IM route of administration suppressed the testosterone levels for the longest period of time. No indication of drug-induced toxicity, as judged by vital signs, systemic side effects, standard laboratory evaluations and some special clinical evaluations, was found during treatment or in the period immediately following the course of therapy. No serious or untoward side effects were encountered.

Administration, Oral↗

PubMed1984

Return of ovulation following a single injection of depo-medroxyprogesterone acetate: a pharmacokinetic and pharmacodynamic study.

The effect of a single dose of 150 mg of depo-medroxyprogesterone acetate (DMPA) on pituitary, ovarian and endometrial function was assessed in relation to the peripheral levels of the compound in 8 women. The levels of medroxyprogesterone acetate (MPA), follitropin (FSH), lutropin (LH), prolactin, estradiol (E2) and progesterone ( Prog .) were measured 3 times a week during a pretreatment (control) cycle and then daily during postinjection weeks 14-17, 22-25 and 30-33. An endometrial biopsy specimen was obtained during postinjection weeks 17, 25 and 33. In three out of 8 subjects the daily hormone assays carried out during postinjection weeks 30-33 indicated anovulatory periods; in these subjects peripheral blood was drawn daily during postinjection weeks 46-49 and a fourth endometrial biopsy was taken during week 49.

Adult↗