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PubMed1997

The influence of medroxyprogesterone on the duration of breast-feeding in mothers in an urban community.

OBJECTIVE: To assess the effect of medroxyprogesterone acetate on lactation when it is given immediately post partum. DESIGN: Prospective cohort study with follow-up through 16 weeks post partum. SETTING: Urban teaching hospital in Baltimore, Md. PARTICIPANTS: Consecutive sample (N = 95) of mothers who were delivered of healthy, term newborns, had home telephones, received either medroxyprogesterone or nonhormonal contraception at discharge, and were currently breast-feeding their newborns. MAIN OUTCOME MEASURES: Lactation (duration and frequency) and timing of first introduction of formula were measured by weekly telephone interviews. RESULTS: Maternal characteristics included the mean +/- SD maternal age (24 +/- 5 years), race (90% African American), history of pregnancy (63% multiparous), marital status or relationship (50% married or living with partner), and medical assistance (81% of the recipients received aid). Women who were receiving medroxyprogesterone (n = 43) were older (P < .05) and were more likely to be married (P < .05) compared with those who were receiving nonhormonal contraception (n = 52). No other factors that were likely to influence lactation were significantly different. Groups did not differ in the baseline-planned duration of lactation. Follow-up data were obtained on 90 women (96%). The groups were comparable in the duration of lactation (medroxyprogesterone: 98%, 74%, 55%, 47%, and 42% were breast-feeding at least once per day at 1, 4, 8, 12, and 16 weeks, respectively [median, 10.14 weeks], vs nonhormonal contraception: 86%, 70%, 47%, 36%, and 30%, respectively [median, 6.57 weeks] [P = .19]). The percentage of subjects who were exclusively breast-feeding at these times and the timing of formula introduction also did not differ by group. CONCLUSION: Medroxyprogesterone, when given to mothers in an urban community immediately after delivery, has no detrimental effect on the duration of lactation, frequency of lactation, and timing of introduction of formula within the first 16 weeks post partum.

Adult↗

PubMed1985

A clinical trial of aminoglutethimide in advanced postmenopausal breast carcinoma: low response in patients previously treated with medroxyprogesterone.

In an attempt to define the influence of prior hormonal treatments upon aminoglutethimide activity in advanced cancer of the breast, 42 heavily pretreated postmenopausal patients received aminoglutethimide, 4 X 250 mg daily, with hydrocortisone or cortisone. Twenty-six received high doses of medroxyprogesterone before entering this study. There was no significant difference in patients' characteristics with or without medroxyprogesterone pretreatment. A comparison of patients with and without prior medroxyprogesterone shows a significant difference in the response rate to aminoglutethimide-hydrocortisone (4 vs 32%, P = 0.02). In patients pretreated with tamoxifen but not with medroxyprogesterone the response rate to aminoglutethimide was 36%. These results suggest that aminoglutethimide has a low activity in breast cancer patients previously exposed to medroxyprogesterone, an agent with glucocorticoid-like activity inducing adrenal suppression.

Adult↗

PubMed1999

Bone mineral density in women using depot medroxyprogesterone acetate for contraception.

OBJECTIVE: To evaluate the possible effects of depot medroxyprogesterone acetate injectable contraception on bone mineral density in reproductive-age women. METHODS: We conducted a population-based cross-sectional comparison of bone mineral density levels in women using depot medroxyprogesterone acetate contraception and in women of similar age not using this method. The study recruited 457 nonpregnant women aged 18-39 years who were enrollees of a Washington state health maintenance organization. One hundred eighty-three women were receiving injections and 274 were not. Bone mineral density at several anatomic sites (spine, femoral neck, greater trochanter, and whole body) was measured using dual-energy x-ray absorptiometry. Data on other factors potentially related to bone density were collected through questionnaire and examination. RESULTS: Overall, age-adjusted mean bone density levels were lower for users of this method than for nonusers at all anatomic sites: The mean difference was 2.5% for the spine (P = .03) and 2.2% for the femoral neck (P = .12). Exposure to depot medroxyprogesterone acetate continued to be significantly (P < .01) associated with decreased bone density at the femoral neck, spine, and trochanter after multivariate adjustment for other risk factors related to bone density. Age-specific comparisons indicated that the major differences in bone density between users and nonusers occurred in the youngest age group (women 18-21 years); the mean femoral neck bone density was 10.5% lower (P < .01) for the exposed women, and differences were consistent (P < .01) across all anatomic sites. We also noted a significant dose-response relation between longer use of depot medroxyprogesterone acetate and decreased bone density levels in this age group (P < .01 for all sites). CONCLUSION: These results provide evidence that contraception with depot medroxyprogesterone acetate, particularly long-term use, may adversely affect bone mineral density levels in young women aged 18-21 years. The implications for future bone health need further study.

Absorptiometry, Photon↗

PubMedDate not supplied

Effect of medroxyprogesterone acetate on the efficiency of an oral protein-rich nutritional support in HIV-infected patients.

We have examined the effect of a medroxyprogesterone therapy in HIV-infected patients under appropriate nutrition for anabolism. The experiments were performed on 12 men (mean age 40 y), HIV seropositive but free of any clinically active opportunistic infection for at least one month. The patients underwent a 2-week baseline diet period (1.2 g protein x kg(-1) body weight (BW) x d(-1)) and then a 5-week experimental period with again the baseline diet in conjunction with supplements including Tonexis HP (0.7 g protein x kg(-1) BW) x d(-1)), L-threonine (0.018 g x kg(-1) BW x d(-1)) and L-methionine (0.013 g x kg(-1) BW x d(-1)). Indeed HIV-infected patients showed deficiencies in these amino acids. They were randomly divided into groups I and II under double-blinded condition. Group II was given medroxyprogesterone acetate (0.4 g x d(-1)) during the last 3 weeks whereas group I received a placebo. All the patients significantly increased their body weight (P < 0.05) during the experimental periods. Those under medroxyprogesterone tended to show a higher but not significant weight gain (+3.1 +/- 1.0 kg in group II and +1.9 +/- 0.3 kg in group I). Blood free amino acids were used as rough indicators of amino acid utilization and were analyzed prior and during acute 150 min intravenous infusion of a complete glucose-amino acid mixture. This test was done before and at the end of the experimental periods. Basal essential blood free amino acids were similar in the two groups and did not change during the experimental period. Most essential amino acids increased following glucose-amino acid infusions. The incremental increase was of less magnitude after the experimental period than before when medroxyprogesterone was present (P < 0.05 for valine, leucine, lysine, threonine and methionine). This was not the case in the absence of the hormone. We concluded that medroxyprogesterone might improve the efficacy of an oral protein-rich nutritional support in HIV-infected patients.

Adult↗

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↗

PubMed1984

Pulmonary lymphangioleiomyomatosis: a case of progesterone receptor positive lymphangioleiomyomatosis treated with medroxyprogesterone, oophorectomy and tamoxifen.

A 28-year-old woman with lymphangioleiomyomatosis had severe changes in the chest radiograph and recurrent pneumothoraces. Pathological tissue from the lung was progesterone receptor positive. After treatment with medroxyprogesterone her condition improved, but did not become clinically stable until after bilateral oophorectomy. Even after oophorectomy her condition deteriorated, when the dose of medroxyprogesterone was decreased. For one year after oophorectomy she has had no episodes of pneumothorax or breathlessness. In order to depress oestrogen activity further the anti-oestrogen drug tamoxifen was added to her usual treatment with medroxyprogesterone. During 2 weeks of treatment with tamoxifen and medroxyprogesterone marked increase of the changes in the chest radiograph were seen and a pneumothorax occurred. After discontinuation of tamoxifen the condition improved and has since been stable on medroxyprogesterone treatment.

Adult↗

PubMedDate not supplied

Additional effects of medroxyprogesterone acetate on mammary tumors in oophorectomized, estrogenized, DMBA-treated rats.

Although hormone replacement therapy not only relieves vasomotor symptoms but also reduces cardiovascular disease and osteoporosis, long-term estrogen therapy increases the risk of endometrial and/or mammary cancer. We investigated the effects of conjugated estrogens with or without medroxyprogesterone acetate in oophorectomized, 7,12-dimethylbenz(a)anthracene-treated rats. Chemically induced mammary carcinogenesis was completely suppressed by the simultaneous oophorectomy, but conjugated estrogens replacement with or without medroxyprogesterone acetate markedly stimulated mammary carcinogenesis in the ovariectomized rats. The chronic administration of conjugated estrogens and medroxyprogesterone acetate markedly reduced the activities of thymidylate synthetase and thymidine kinase and bromodeoxyuridine-immunoreactive (S-phase) cells in mammary tumors. These results indicate that the treatment using conjugated estrogens with or without medroxyprogesterone acetate may promote the mammary carcinogenesis in postmenopausal women but the chronic administration of medroxyprogesterone acetate may alter the development of established mammary cancer.

9,10-Dimethyl-1,2-benzanthracene↗

PubMed1979

A comparison of medroxyprogesterone serum concentrations by the oral or intramuscular route in patients with persistent or recurrent endometrial carcinoma.

A randomized study, comparing serum medroxyprogesterone concentrations by the oral and intramuscular routes, was performed on 22 patients with persistent or recurrent endometrial adenocarcinoma by six institutions of the Gynecologic Oncology Group. The oral group (11 patients) received cutaneous Provera (medroxyprogesterone), 50 mg three times a day, and the intramuscular group (11 patients) received 300 mg of Depo-Provera (medroxyprogesterone) weekly for at least 2 months. Serum levels were evaluated at 0, 2, 4, 6, 8, 10, and 12 hours after administration and every day for the first week and weekly thereafter for 8 weeks. The mean serum levels (nanograms per milliliter) of medroxyprogesterone in the oral group were consistently higher than the corresponding mean levels of the intramuscular group. In addition, from the first through eighth weeks, the measurements (medians) for the oral group were statistically higher than those for the intramuscular group. Although the study indicates a significant increase in serum levels achieved by the oral route, the follow-up period of patients under study is too early to evaluate its clinical effectiveness as compared to the intramuscular route.

Adenocarcinoma↗

PubMed1982

Medroxyprogesterone acetate and homozygous sickle-cell disease.

The haematological and clinical effects of medroxyprogesterone acetate in homozygous sickle-cell (SS) disease were assessed in a 2-year controlled crossover trial completed by 23 patients. Haematological indices remained steady during the placebo phase, but during the medroxyprogesterone-acetate phase fetal haemoglobin, total haemoglobin, red-cell mass, and red-cell survival rose significantly, and reticulocytes, irreversibly-sickled-cell counts, and total bilirubin fell significantly. Painful crises were significantly less frequent during the medroxyprogesterone-acetate than the placebo phase. These results are compatible with an inhibition of in-vivo sickling in patients with SS disease during medroxyprogesterone-acetate treatment. The mechanisms of such an effect require further study.

Adult↗

PubMed1983

Effects of prednisolone and medroxyprogesterone on corneal wound healing, ulceration, and neovascularization.

Albino rabbits were treated four or six times daily with 1% prednisolone acetate, 1% medroxyprogesterone acetate, or a control vehicle, after one of three conditions. First, after 3-mm linear perforating stromal incisions; drugs were given for seven days, and wound bursting strength was determined. Prednisolone suppressed wound tensile strength by 20%; medroxyprogesterone suppressed it by 11%. Second, after trephination, drug administration for 14 days decreased collagen formation in the scar buttons by 43% in the prednisolone-treated group and 39% in the medroxy-progesterone-treated group. Third, after thermal burns; when drug application followed the burn immediately, deep ulceration or perforation developed in 85% of the controls, in none of the prednisolone-treated group, and in 17% of the medroxyprogesterone-treated group. When drug delivery was withheld until day 6, severe ulceration developed in 44% of both groups. In both experiments, stromal neovascularization was markedly suppressed by prednisolone, but only moderately decreased by medroxyprogesterone.

Animals↗

PubMed1996

Depot medroxyprogesterone acetate versus an oral contraceptive combined with very-low-dose danazol for long-term treatment of pelvic pain associated with endometriosis.

OBJECTIVE: Our purpose was to evaluate the efficacy and safety of depot medroxyprogesterone acetate versus an oral contraceptive combined with very-low-dose danazol in the long-term treatment of pelvic pain in women with endometriosis. STUDY DESIGN: Eighty patients with endometriosis and moderate or severe pelvic pain were randomized to treatment for 1 year with intramuscular depot medroxyprogesterone acetate 150 mg every 3 months or a cyclic monophasic oral contraceptive (ethinyl estradiol 0.02 mg, desogestrel 0.15 mg) combined with oral danazol 50 mg a day for 21 days of each 28-day cycle. The women were asked to grade the degree of their satisfaction at the end of therapy. Variations in severity of symptoms during treatment were determined by a 10 cm visual analog and a 0- to 3-point verbal rating scale. RESULTS: Twenty nine of 40 subjects (72.5%) in the depot medroxyprogesterone acetate group were satisfied after 1 year of therapy compared with 23 of 40 (57.5%) in the oral contraceptive plus danazol group (chi 2(1) = 1.37, p = 0.24, odds ratio 1.95, 95% confidence interval 0.76 to 4.97). A significant decrease was observed in all symptom scores in both study groups. At 1-year assessment dysmenorrhea was significantly greater in women allocated to oral contraceptive plus danazol. CONCLUSION: Depot medroxyprogesterone acetate seems to be an effective, safe, and convenient low-cost treatment for pelvic pain associated with endometriosis. However, women should be carefully counseled regarding menstrual changes and the potential prolonged delay in the return of ovulation.

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↗

PubMed1989

Specific and sensitive quantitation of medroxyprogesterone acetate in human serum by gas chromatography-mass spectrometry.

A procedure for the quantitation of medroxyprogesterone acetate in serum using gas chromatography-quadrupole mass spectrometry is described. Medroxyprogesterone propionate, synthesized from medroxyprogesterone, was used as the internal standard. The serum samples were extracted on Bond Elut C18 cartridges, and the acetate and propionate were determined as their 3-enol heptafluorobutyrate esters by selected-ion monitoring technique. The linear range of the standard curve in serum was 0.5-30 ng/ml with a lower limit of quantitation of 0.5 ng/ml. The coefficient of variation of the method was 3.1% at 10 ng/ml and 5.5% at 1 ng/ml. The method is very rapid, and it has been applied for routine measurements of medroxyprogesterone acetate levels in human serum after oral administration of 10 or 20 mg.

Gas Chromatography-Mass Spectrometry↗

PubMed1989

Depot medroxyprogesterone (Depo-Provera) and risk of breast cancer.

OBJECTIVE: To determine whether use of the injectable contraceptive depot medroxyprogesterone acetate (Depo-Provera) affects the risk of breast cancer in women. DESIGN: A population based case-control study. SETTING: Nationwide community study. SUBJECTS: 891 Women aged 25-54 with newly diagnosed breast cancer were compared with 1864 women selected at random from the electoral rolls. INTERVENTION: Women were interviewed by telephone about past use of contraceptives and about possible risk factors for breast cancer. MAIN OUTCOME MEASURE: Relative risk of breast cancer in women who had used medroxyprogesterone. RESULTS: Medroxyprogesterone had been used by 110 patients and 252 controls. Overall, the relative risk of breast cancer associated with any duration of use was 1.0 (95% confidence interval 0.80 to 1.3). In women aged 25-34 the relative risk was 2.0 (1.0 to 3.8). The relative risk was highest in women aged 25-34 who had used the drug for six years or longer, although there were few women in this category. Women who had used it for two years or longer before age 25 had an increased risk of breast cancer (relative risk 4.6; 1.4 to 15.1). CONCLUSION: Despite the lack of an overall association these findings suggest that medroxyprogesterone may increase the risk of breast cancer in young women.

Adult↗

PubMed1991

A randomized, double-blind, placebo-controlled, cross-over trial to assess the side effects of medroxyprogesterone acetate in hormone replacement therapy.

Cyclic progestin therapy has been widely advocated as an adjunct to postmenopausal estrogen replacement therapy to reduce the risk of endometrial carcinoma. Acceptance of this approach, however, appears to have preceded detailed evaluation of possible adverse side effects of progestins that could result in patient noncompliance. We evaluated the nonmenstrual physical and psychological side effects of oral medroxyprogesterone acetate given in conjunction with transdermal estrogen in two groups of women with previous hysterectomy and oophorectomy. Twenty-four women with prospectively documented severe premenstrual syndrome (PMS) before surgery and 24 women with no such history of adverse premenstrual changes received transdermal estrogen 100 micrograms on days 1-25 and either oral medroxyprogesterone acetate 10 mg daily or an identical placebo (days 12-25) in a randomized, double-blind, cross-over design. Mood and physical symptoms were monitored prospectively, using daily self-ratings on the Daily Symptoms Checklist. The Beck Depression Inventory and Premenstrual Tension Self-Rating Scale were completed on day 24. At the study's completion, the patients were asked which treatment period they preferred. Paired comparisons did not reveal any significant differences, and preference for treatment was equally divided between medroxyprogesterone acetate and placebo. We conclude that addition of medroxyprogesterone acetate 10 mg/day for 14 days to cyclic transdermal estrogen therapy (days 1-25) produces no consistent adverse physical or psychological effects on women for one cycle of treatment, regardless of their PMS history.

Double-Blind Method↗

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↗

PubMed1985

Short-term effects of tamoxifen, medroxyprogesterone acetate, and their combination on receptor kinetics and 17 beta-hydroxysteroid dehydrogenase in human endometrium.

The interactions of an antiestrogen (tamoxifen) and a progestin (medroxyprogesterone acetate) on endometrial 17 beta-hydroxysteroid dehydrogenase activities were studied in short-term experiments (four to 96 hours) in normally menstruating women at the follicular phase and were related to simultaneously measured concentrations of cytosol and nuclear estrogen and progestin receptors. Tamoxifen effected a decrease in the activity of 17 beta-hydroxysteroid dehydrogenase. This was associated with an apparent translocation to and retention of estrogen receptor in the nucleus without any significant changes in cellular progestin receptor. Medroxyprogesterone acetate administration led to a rapid increase in endometrial 17 beta-hydroxysteroid dehydrogenase activity, and depletion of cytosol and total cellular progestin receptor. Combination of the drugs led to effects that could be addressed to the individual drugs separately, and under the experimental conditions the effects of medroxyprogesterone acetate were uninfluenced by simultaneous tamoxifen administration. Put together with the authors' previous findings on the same parameters during long-term (three-week) medroxyprogesterone acetate administration, it seems possible that potentiation of progestin effects on endometrial carcinoma is not to be expected during long-term simultaneous antiestrogen-progestin treatment. It is therefore likely that the favorable effects of combining these two drugs in long-term treatment are due to their different endocrine action mechanisms.

17-Hydroxysteroid Dehydrogenases↗

PubMed1998

Cytologic changes in cervical smears associated with prolonged use of depot-medroxyprogesterone acetate.

BACKGROUND: Hormonal effects have always played a significant role in gynecologic cytology. In atrophic and postpartum smears, interpretation may be complicated by large numbers of parabasal cells with high nuclear cytoplasmic ratios and hyperchromatic nuclei that mimic precancerous lesions (squamous intraepithelial lesions, SILs). The authors have observed atrophic and postpartumlike changes in patients receiving depot-medroxyprogesterone acetate for prolonged periods. These alterations may lead to diagnostic uncertainty or falsely suggest the presence of SIL. METHODS: To evaluate the effect of chronic hormone use, smears from 29 depot-medroxyprogesterone acetate users (average age, 35.9 years) who had been amenorrheic for 5-72 months (average, 22.6 months) were identified. This group was matched with 25 nonusers (average age, 31.9 years). Maturation values (MVs) were calculated for both groups and cellular findings were evaluated. RESULTS: The user group had a significantly lower MV (38.45 vs. 64.60, P < 0.001). Among users, 6 of 29 smears (21%) were abnormal. One low grade SIL was biopsy-confirmed, but two high grade SILs and three smears of ASCUS had a negative Papanicolaou (Pap) smear and/or biopsy follow-up. Among nonusers, 4 of 25 smears (16%) were abnormal. Two patients with high grade SIL smears had positive biopsy or Pap smear follow-up, one with an ASCUS smear had a negative Pap smear follow-up, and one with a low grade SIL was lost to follow-up. CONCLUSIONS: The immature cellular pattern seen in smears from long term depot-medroxyprogesterone acetate users led to difficulty in determining the diagnosis in some cases. ASCUS cases among users were associated with high nuclear cytoplasmic ratios and hyperchromasia in parabasal metaplasialike cells. Biopsies in these cases showed epithelial atrophy, which was often associated with acute inflammation. In view of the fact that long term depot-medroxyprogesterone acetate administration may induce changes that mimic high grade SIL in a population already at high risk for SIL, there may be problematic cases in which diagnostic uncertainty is inevitable.

Adult↗