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PubMed1994

Premenopausal bone loss and depot medroxyprogesterone acetate administration.

A 39-year-old woman on depot medroxyprogesterone acetate for 17 years developed multiple fractures after falling from a stationary horse. Densitometry revealed significant osteopenia. Although the reported patient was a thin, Caucasian woman, she did not have any other significant risk factors for osteoporosis except for a possible state of partial estrogen deficiency induced by the use of depot medroxyprogesterone acetate. Studies have shown that the estradiol levels of premenopausal women who have received this hormonal contraceptive for more than 1 year never reach those seen in the mid-cycle or luteal phase of the normal menstrual cycle. The estradiol levels are comparable only with those found in the early follicular phase. Therefore, women who use depot medroxyprogesterone acetate are in a state of partial estrogen deficiency, which may be associated with increased bone loss.

Adult↗

PubMed1998

Depot medroxyprogesterone acetate or oral contraception in postpartum adolescents.

OBJECTIVE: To compare rates of method continuation and repeat pregnancy among postpartum adolescents selecting depot medroxyprogesterone acetate or oral contraceptives (OCs). METHODS: A retrospective study of 161 adolescents aged 19 years and younger who gave birth at an urban teaching hospital between May 1, 1994, and April 30, 1995, returned to the hospital's family planning clinic within 14 weeks of delivery and chose depot medroxyprogesterone acetate (n=111, 69%), or OC (n=50, 31%) as their postpartum contraceptive method. Most subjects were black (99%), single (97%), and on medical assistance (85%). Data were gathered 12-18 months postpartum (mean+/-standard deviation [SD] 14.5+/-1.6 months) by telephone interview and medical record review. The main outcome measures were method continuation and repeat pregnancy. RESULTS: The mean (+/-SD) age at delivery was 17.8+/-1.4 years. Variables differentiating subjects selecting depot medroxyprogesterone acetate or OC included multiparity (34% versus 12%, P < .05), mean age at first pregnancy (15.9 versus 16.6 years, P < .05), and mean age at first delivery (16.1 versus 16.9 years, P < .05). The survival curves for depot medroxyprogesterone acetate and OC continuation differed significantly (median duration of use 8.1 versus 5.4 months, respectively), but the continuation rates at 12 months were similar (34% versus 32%). The survival curves for repeat pregnancy among subjects selecting depot medroxyprogesterone acetate differed significantly from curves of those choosing OC, with repeat pregnancy rates of 15% and 36% by 15 months. Postpartum selection of OC was the only variable entering a Cox regression model designed to predict repeat pregnancy (relative risk 3.0, 95% confidence interval 1.4, 6.7). CONCLUSION: Adolescent mothers choosing depot medroxyprogesterone acetate or OC immediately postpartum face similarly high rates of method discontinuation and repeat pregnancy within 1 year.

Adolescent↗

PubMed1979

Mammary tumors and serum hormones in the bitch treated with medroxyprogesterone acetate or progesterone for four years.

After 4 years of a long-term contraceptive steroid safety study, the incidence and the histologic types of mammary dysplasia produced are shown to be similar in beagles treated with medroxyprogesterone acetate (medroxyprogesterone) or progesterone. Serum insulin, thyroid-stimulating hormone (TSH), triiodothyronine, growth hormone, prolactin, 17 beta-estradiol, progesterone, and cortisol were determined by radioimmunoassay on samples collected after 45 months of treatment. Serum growth hormone and insulin concentrations were elevated in a dose-related manner in both treatment groups. Levels of triiodothyronine, cortisol, and 17 beta-estradiol (medroxyprogesterone only) were lowered. TSH and prolactin concentrations were not changed. Pituitary-gonadal hormone interaction in the pathogenesis of mammary neoplasia of the dog is discussed. Prolonged treatment of beagles with doses of progesterone or medroxyprogesterone 1 to 25 times the human contraceptive dose or luteal phase (dog) levels, respectively, results in a dose-related incidence of mammary nodules.

Adenoma↗

PubMed1977

In vitro metabolism of progestins. III. The metabolic clearance rate of medroxyprogesterone acetate in monkeys.

3H-medroxyprogesterone acetate (MPA) was synthesized by selective catalytic tritiation of the delta1-olefinic bond of 6alpha-methyl-17alpha-hydroxy-pregna-1,4-diene-3,20-dione acetate. The metabolic clearance rate of MPA (MCRMPA) was determined in 9 female Rhesus monkeys by the single injection technique. The blood MCRMPA was 201 +/- 19 L/day (42.2 +/- 4.0 L/day/kg) which was approximately the same as that reported for progesterone clearance in the monkey. We conclude that a greater biological activity of MPA compared to progesterone cannot be related to its prolonged retention in the blood. Although both MPA and amino-glutethimide alter the rate of steroid metabolism in some species, neither of these agents influences the metabolic clearance rate of 3H-MPA in the monkey.

Aminoglutethimide↗

PubMed1997

[A case of dural sinus thrombosis during the medication of medroxyprogesterone acetate].

It is reported that medroxyprogesterone acetate (MPA) causes venous thrombosis as one of the side effects. A 49-year-old woman suffering from metastatic lung carcinoma from breast carcinoma was administered MPA 1200 mg/day for about four months. Thereafter she complained of dizziness about two weeks but the general practitioners could detect no abnormality on physical examinations and on brain CT X-ray findings. Six days later, she died suddenly at her home. Forensic autopsy findings revealed the marked superior sagital sinus thrombosis and the malignant lymphadenomatosis caused by metastatic lung carcinoma. As the patient had not disease or trauma causing dural sinus thrombosis except for the administration of MPA, we concluded that superior sagital sinus thrombosis was due to the medication of MPA. This case illustrates that forensic pathologist should consider the major side effect of some drugs like our case.

Antineoplastic Agents, Hormonal↗

PubMed1994

Breast cancer and depot-medroxyprogesterone acetate: a review.

Depot-medroxyprogesterone acetate (DMPA) has been used world-wide since 1964 as a contraceptive in spite of the fact that it was only in 1992 licensed for contraceptive use in the USA due to concern about a possible breast cancer risk. Two recent studies have considered DMPA use and risk of breast cancer and these and earlier studies are reviewed here. Overall, the results are reassuring but there is some evidence that breast cancer risk may be increased in women using DMPA when very young and particularly in recent users. Current knowledge of the biology of human breast cancer is such that it is difficult to judge the biological plausibility of this evidence. There is no doubt that DMPA is a highly effective form of contraception and any overall assessment must take into account all the relevant risks and benefits. Thus, the risk-benefit equations in developed and developing countries must allow for different levels of maternal mortality and morbidity, as well as differing underlying cancer rates.

Breast Neoplasms↗

PubMed1991

Mass spectrometric and high-performance liquid chromatographic studies of medroxyprogesterone acetate metabolites in human plasma.

Medroxyprogesterone acetate (MPA) treatment has been shown to exert several beneficial effects in cancer patients. It has been suggested that such effects are due in part to the metabolites derived from MPA in vivo. The first results are reported on the identification of 2 alpha-hydroxy- and 21-hydroxy-MPA, 20-dihydro-MPA, 17 alpha-acetoxy-2 alpha,3 beta-dihydroxy-6 alpha-methylpregn-1,4-dien-20-one and two X,21-dihydroxy-MPAs, one of them presumably being 6 alpha-hydroxymethyl-21-hydroxy-MPA, in patient's plasma by high-performance liquid chromatographic (HPLC), gas chromatographic-mass spectrometric and NMR methods. Additionally, the presence of other metabolites such as di- and tetrahydro-MPAs and 6,21-dihydroxy-MPA, found in urine and other samples, was demonstrated in plasma. For routine clinical examinations an HPLC method is described for determination of, e.g., the unreduced MPA metabolite group in Sep-Pak-ODS column extracts of patients' plasma.

Chromatography, High Pressure Liquid↗

PubMed1986

Pre-optic and hypothalamic neurons accumulate [3H]medroxyprogesterone acetate in male cynomolgus monkeys.

Medroxyprogesterone acetate (MPA) is a synthetic progestin that is reported to be effective in the treatment of paraphilic behavior, including paraphilic aggression, in men. The mechanisms and sites of action for its behavioral effects are not known. Thaw-mount autoradiography was used to help identify sites in the brain at which MPA may act in a male primate. Two adult, castrated male cynomolgus monkeys were administered [3H]MPA and killed one hour later. Radioactivity was concentrated in the nuclei of many neurons in the medial preoptic nucleus (n.), anterior hypothalamic area, ventromedial hypothalamic n., and arcuate n. Virtually no labeled cells were observed in the bed n. of the stria terminalis, lateral septal n., or amygdala. Analysis by high performance liquid chromatography of brain samples from the same animals demonstrated that 84% of the extractable radioactivity in cell nuclei from the hypothalamus and preoptic area was in the form of unmetabolized [3H]MPA. The localization of MPA-concentrating neurons in regions of the brain known to be implicated in regulating both sexual behavior and pituitary function suggests that, among other sites of action, MPA may act directly upon the brain.

Animals↗

PubMed2000

Use of depot medroxyprogesterone acetate in Thai adolescents.

Depot medroxyprogesterone acetate (DMPA) has been available for several decades in many parts of the world including Thailand, but few data have been reported concerning adolescents. The aim of the study was to determine the use of DMPA for contraceptive use among Thai adolescents. A cross-sectional study has been designed. A total of 108 adolescents who used DMPA as contraception between January 1, 1996, and December 31, 1997, at King Chulalongkorn Hospital were reviewed by chart. Most of the participants were in late adolescence and average age was 17.6 years of age. Six-month continuation rate was 69.4%, and at 9 months and 1 year were 42.6 and 30.6%, respectively. Irregular bleeding, amenorrhea, and weight gain were the side effects frequently reported. The most common side effect that caused discontinuation within 1 year was irregular bleeding. With prolonged use, the number of cases with irregular bleeding decreased and the duration of bleeding was shortened, whereas the rate of amenorrhea increased. No pregnancy occurred during the study period. In conclusion, DMPA is an effective contraception in adolescents. However, the continuation rate is lower than that for adult women. The main reason for discontinuation is irregular bleeding.

Adolescent↗

PubMedDate not supplied

Liquid chromatographic determination of medroxyprogesterone acetate in tablets.

A reverse-phase liquid chromatographic method is described for the assay of medroxyprogesterone acetate in tablets. An octadecylsilane (C18) column with a mobile phase of methanol-0.01M dibasic ammonium phosphate (80 + 20 v/v, pH 7.2 +/- 0.1) and photometric detection at 254 nm separates medroxyprogesterone acetate from excipients. Detector responses were linear to concentrations of medroxyprogesterone acetate over the range 50-150 micrograms/mL (r = 0.999). Mean recovery of medroxyprogesterone acetate added to tablet excipients was 100.8%. Mean assay results were 101.3% (n = 3). The assay results are comparable to those obtained by the compendial liquid chromatographic method.

Chromatography, Liquid↗

PubMed1996

The nuclear channel system in endometrial adenocarcinoma exposed to medroxyprogesterone acetate.

The nuclear channel system (NCS), giant mitochondria and subnuclear glycogen form a triad of ultrastructural features observed in normal human endometrial epithelium in response to progestational steroids. Both the giant mitochondria and subnuclear glycogen have been described in endometrial adenocarcinoma, but the NCS has not. This article reports the development of the NCS in adenocarcinoma treated with medroxyprogesterone acetate. Previous studies suggest that the NCS in normal tissue is a response to the acyl group in the 17-beta position of the D-ring of some progestational steroids, such as medroxyprogesterone acetate. Medroxyprogesterone acetate was administered to 12 postmenopausal women with endometrial adenocarcinoma. Hysterectomies were performed 8 to 20 days after treatment. Pretreatment specimens were also obtained on 8 of the 12 patients. Using standard electron microscopy procedures, light microscopy on plastic semithin sections was first used to confirm the presence of tumor. Thin sections of malignant endometrium were prepared and evaluated ultrastructurally for progestational alterations. Abnormal giant mitochondria and subnuclear glycogen were found both before and after treatment. The third element of the triad, the NCS, was not observed in any of the available pretreatment biopsies, but was seen in three of the treated specimens. Thus it appears that the NCS is a response to the given progesterone therapy.

Adenocarcinoma↗

PubMed1991

Treatment of rat prostatic adenocarcinoma with medroxyprogesterone acetate (MPA): effects on growth and morphology.

Rats bearing the Dunning R3327H prostatic carcinoma were castrated and supplemented with testosterone propionate. These rats were then treated with estradiol benzoate or medroxyprogesterone acetate alone or in combination with estradiol. During the treatment period of six weeks, the growth rate of the prostatic tumors was measured. At the end of the treatment period the morphology of the tumors was also studied. It was found that medroxyprogesterone acetate is as effective as estradiol in inhibiting the growth of the Dunning prostatic carcinoma and that the combination of medroxyprogesterone acetate and estradiol was more efficient in that respect than estradiol alone. Morphometric evaluation of the tumor epithelium and stroma showed a decrement of epithelial growth in all treatment groups, while the groups treated with medroxyprogesterone acetate, both alone or in combination with estradiol, also showed an inhibited growth of the tumor stroma. It was concluded that medroxyprogesterone acetate probably has direct inhibitory effects on prostatic tumor cells in the Dunning model and that medroxyprogesterone acetate may act in an additive manner with estradiol.

Adenocarcinoma↗

PubMed2005

[Conservative surgery combined with depot medroxyprogesterone acetate in treatment of moderate or severe endometriosis].

OBJECTIVE: To evaluate the efficiency and side-effects of depot medroxyprogesterone acetate in the treatment of moderate or severe endometriosis after conservative surgery. METHODS: Ninety-four women with moderate or severe endometriosis after conservative surgery were divided into three groups: 34 cases in the group of depot medroxyprogesterone acetate (DMPA) received intramuscularly depot medroxyprogesterone acetate 150 mg every 28 - 30 days for 6 months; 30 cases in the group of gonadotropin releasing hormone agonists (GnRH-a) received hypodermically leuprorelin acetate 3.75 mg every 28 - 30 days for 6 months; 30 cases in the group of control did not receive any postoperative medical treatment. Patients' symptoms and signs including pelvic pain, pelvic tenderness, menstrual and weight changes were recorded before and after treatment. Liver and renal functions, sex hormone level were also examined at the same time. RESULTS: Both DMPA and GnRH-a treatment achieved similar significant relief of pelvic symptoms and signs (88% and 93%) compared with the control group (chi(2) = 12.273, P < 0.01; chi(2) = 9.604, P < 0.01). The cumulative recurrence rates of DMPA and GnRH-a groups were 6% and 7%, significantly lower than that of the control group (chi(2) = 5.222, P < 0.05; chi(2) = 4.320, P < 0.05). There were no significant differences between DMPA and GnRH-a groups (chi(2) = 0.488, P > 0.05; chi(2) = 0.017, P > 0.05). Serum estradiol (E(2)) level was significantly reduced in both DMPA and GnRH-a groups, but serum E(2) was maintained at the level of early follicular phase in the group of DMPA (120 +/- 9) pmol/L and menopause phase level in the group of GnRH-a (62 +/- 9) pmol/L. The main side effects of DMPA were menstrual changes, weight gain and delay of ovulation. CONCLUSION: Depot medroxyprogesterone acetate seems to be an effective, safe, and convenient treatment for endometriosis with low-cost, good compliance, and few side effects.

Adult↗

PubMed1994

Toxicology of depot medroxyprogesterone acetate.

Depo-Provera (depot-medroxyprogesterone acetate or DMPA), administered either subcutaneously or intramuscularly, has undergone a thorough toxicological evaluation in a number of animal species. DMPA has been tested in short- and long-term toxicity studies in rodents, rabbits, and monkeys. It has been examined for its effects on reproduction in mice, rats, and rabbits, and for carcinogenic potential in rats, mice, beagle dogs, and rhesus monkeys. Genotoxicity tests have been performed in vitro and in vivo. This paper describes the toxicology data submitted to the US FDA in support of the New Drug Application (NDA) for Depo-Provera as well as data published in the literature. When interpreted in the light of the available pharmacokinetic information, these data demonstrate that DMPA is not significantly different from other contraceptive progestogens in its toxic and tumorigenic potential.

Animals↗

PubMed2001

Medroxyprogesterone acetate therapy for patients with adenocarcinoma of the endometrium who wish to preserve the uterus-usefulness and limitations.

BACKGROUND: To determine the effectiveness of medroxyprogesterone acetate therapy for women with endometrial adenocarcinoma who wish to preserve their uterus. STUDY DESIGN: Fifteen patients with endometrial carcinoma (12 with grade 1 endometrioid adenocarcinoma. 2 with grade 2 adenocarcinoma and 1 with adenoacanthoma) were treated with high-dose medroxyprogesterone acetate alone as primary therapy and their clinical responses evaluated. RESULTS: Seven of the 12 cases (58%) with grade I adenocarcinoma and one of the two (50%) with grade 2 carcinoma responded initially to medroxyprogesterone acetate. The median length of treatment required for regression was 29 weeks. Three patients who initially responded relapsed. Thirteen patients are alive without evidence of disease as of December 1999 (10 to 146 months, median; 4 years and 11 months) and one is continuing medroxyprogesterone acetate therapy as a final follow-up. One patient was lost to follow-up. Two patients have conceived having three healthy infants. CONCLUSION: Treatment of endometrial carcinoma with high-dose medroxyprogesterone acetate could be an alternative to hysterectomy, although the successful rate is limited.

Adenocarcinoma↗

PubMed1991

Prevention of osteoporosis by medroxyprogesterone acetate in postmenopausal women.

The effect of medroxyprogesterone acetate 10 mg BID alone, conjugated estrogens alone or in a combination regimen for the prevention of osteoporosis was determined in 36 postmenopausal women using single photon densitometry. No significant differences in cortical or trabecular bone mass over time were detected in women between the three treatment groups, although a slight increase in bone mass was noted in women with the combined therapy. Medroxyprogesterone acetate appears efficacious in preventing postmenopausal osteoporosis, and may be especially useful in women with contraindications to estrogen replacement therapy.

Adult↗

PubMed1994

Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone. The Menopause Study Group.

OBJECTIVE: We evaluated four oral combinations of conjugated estrogens (Premarin) and medroxyprogesterone acetate in preventing endometrial hyperplasia, which can occur with conjugated estrogens alone. STUDY DESIGN: This was a 1-year prospective, double-blind, randomized, multicenter study in 1724 postmenopausal women. All five groups took conjugated estrogens (0.625 mg) daily. The respective medroxyprogesterone acetate dosages were 2.5 and 5.0 mg daily (groups A and B) and 5.0 and 10.0 mg for 14 days per 28-day cycle (groups C and D). RESULTS: Among the 1385 patients with valid biopsy data, endometrial hyperplasia developed in 20% in the conjugated estrogens-treated group and < or = 1% in each of the four conjugated estrogens/medroxyprogesterone acetate-treated groups. The incidence of endometrial hyperplasia did not differ significantly between any of the conjugated estrogens/medroxyprogesterone acetate regimens. However, none of the patients receiving the two higher medroxyprogesterone acetate dosages (groups B and D) had endometrial hyperplasia. CONCLUSION: The endometrial hyperplasia incidence was significantly lower in women treated with conjugated estrogens and medroxyprogesterone acetate than in women treated with conjugated estrogens alone.

Aged↗

PubMed1999

Bone density effects of continuous estrone sulfate and varying doses of medroxyprogesterone acetate. Ogen/Provera Study Group.

OBJECTIVE: To establish the optimum oral daily dose of medroxyprogesterone acetate with estrone sulfate for 2 years to maintain bone density. METHODS: A multicenter, double-blind study involved 568 postmenopausal women given estrone sulfate, 1.25 mg, and randomized to receive 2.5, 5, or 10 mg of medroxyprogesterone acetate. Bone density analyses of the lumbar spine and femoral neck were done at baseline and 12 and 24 months. RESULTS: There was a significant increase from baseline to 24 months in mean lumbar spine (4.0% +/- 0.27%) and femoral neck (3.2% +/- 0.28%) bone density, with no significant differences between the treatment groups. Factors most influencing bone density changes were baseline bone density and treatment duration. Significant increases were seen in the spine over 2 years; in the hip, those occurred in the first 12 months only. In both sites, lower baseline bone density resulted in greater increases. In the spine only, no previous hormone replacement therapy, higher body mass index, more than 2 years postmenopause, and nonsmoking resulted in greater gains. Once those covariates and center-to-center variations were corrected for, in the spine, the 10-mg group had smaller increases than the other groups. Changes were unrelated to age, parity, calcium, and alcohol intakes in either site. CONCLUSION: Daily estrone sulfate, 1.25 mg, with 2.5, 5, or 10 mg medroxyprogesterone acetate was effective for preventing bone loss in postmenopausal women.

Adult↗