Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new provera research articles will be listed here shortly after becoming available to us.
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Medical research on provera
Cervical dysplasia and cancer and the use of hormonal contraceptives in Jamaican women.
BMC Womens Health. 2008; 8: 9
McFarlane-Anderson N, Bazuaye PE, Jackson MD, Smikle M, Fletcher HM
BACKGROUND: This study was conducted to determine whether use of hormonal contraceptives is associated with cervical dysplasia and cancer in a population where there is widespread use of hormonal contraception and the rates of cervical cancer remain high at 27.5/100,000. METHODS: A case-control study was conducted among women visiting the colposcopy and gynaelogical clinics at a tertiary referral hospital. Two hundred and thirty six cases CIN I (72), II (59), III (54), cancer (51) and 102 controls, consented and were interviewed on use of contraceptives using a structured questionnaire. Logistic regression was used to determine odds ratios (ORs) and 95% confidence intervals (CIs) associated with use of hormonal contraception in cases and controls and in low and high risk cases. Recruitment was carried out from 2001-2002. RESULTS: Contraceptives used were: oral contraceptives - 35%, injections (depot medroxy progesterone acetate (Depo-provera) - 10%, Intrauterine devices - 2%, combinations of these and tubal ligation - 30%. 23% reported use of 'other' methods, barrier contraceptives or no form of contraception. Barrier contraceptive use was not significantly different between cases and controls. Current and/or past exposure to hormonal contraceptives (HC) by use of the pill or injection, alone or in combination with other methods was significantly higher in the cases. In multivariate analysis with age and number of sexual partners as co-variates, use of hormonal contraception was associated both with disease, [OR, 1.92 (CI 1.11, 3.34; p = 0.02] and severity of the disease [OR, 2.22 (CI 1.05, 4.66) p = 0.036]. When parity and alcohol consumption were added to the model, hormonal contraception was no longer significant. The significant association with high risk disease was retained when the model was controlled for age and number of sexual partners. Depo-provera use (with age and number of sexual partners as covariates) was also associated with disease [OR, 2.43 (CI 1.39, 4.57), p = 0.006] and severity of disease [OR 2.51 (1.11, 5.64) p = 0.027]. With parity and alcohol added to this model, depo-provera use retained significance. Exposure to HC > 4 years conferred more risk for disease and severity of disease. CONCLUSION: Hormonal contraception did confer some risk of dysplasia and women using HC should therefore be encouraged to do regular Pap smear screening.
Depot-medroxyprogesterone acetate: an update.
Arch Gynecol Obstet. 2008 Jul; 278(1): 1-12
Bakry S, Merhi ZO, Scalise TJ, Mahmoud MS, Fadiel A, Naftolin F
OBJECTIVE: Depo-Provera((R)) is a contraceptive approved by the US Food and Drug Administration (FDA) since 1992 and used worldwide by more than 90 million women. AIM OF STUDY: Despite the fact that progestins are endogenous hormones that are secreted by the body, its excess might lead to detrimental health effects. Whether progestins as contraceptives are friends or foes is a questionable matter. In this manuscript, we drive the attention to both usage and side effects Depo-Provera. RESULTS: Depot-medroxyprogesterone acetate (DMPA) is a highly effective, convenient non-daily hormonal contraceptive option that has been available worldwide for many years. The experience with DMPA provides a large body of long-term data regarding the efficacy and safety of this contraceptive method; this long-term experience has established that the use of DMPA does not increase the risk of cardiovascular events, breast cancer, other gynecologic malignancy, or postmenopausal fracture; however, patients are often more concerned about the relatively immediate effects of contraceptives such as potential changes in menstrual cycle, body weight, and mood disturbances. CONCLUSION: Concerns about such issues may lead to reluctance to initiate therapy or premature discontinuation. Counseling and understanding of women's concerns and experiences using Depo-Provera is important and could help health care providers redesign counseling strategies to improve contraceptive continuation and improve patient adherence.
Reproductive hormones and skeletal health in young women.
J Clin Endocrinol Metab. 2008 Apr; 93(4): 1175-7
Ott SM
Clin Exp Obstet Gynecol. 2008; 35(1): 57-60
Küçük T, Ertan K
OBJECTIVE: To compare the efficacy of three progestin regimens in perimenopausal menorrhagia. DESIGN: One hundred thirty-two women with menorrhagia were included in this prospective, randomized, comparative trial. Women were randomized to three groups of 44 in each, either to get a single shot of depot medroxyprogesterone acetate, intramuscularly (Group 1), or medroxyprogesterone acetate in a daily dose of 5 mg orally (Group 2), or the levonorgestrel releasing intrauterine system (LNG-IUS) (Group 3). The Mann-Whitney U-test was applied to compare independent groups. RESULTS: Pictorial blood loss assessment chart (PBAC) score, the duration of bleeding and mean hemoglobin level were improved in all groups. Comparing the groups we noted that for the PBAC, there was no statistically significant difference between groups 1 and 2, while group 3 was superior to both groups 1 and 2 (p < 0.05 and p < 0.05, respectively). Mean duration of menstruation showed no differences among the groups. Hemoglobin levels were no statistically significant differences between groups 1 and 2, while group 3 was superior to both groups 1 and 2 (p < 0.05 and p < 0.05, respectively). CONCLUSION: The efficacies of oral and intramuscular medroxyprogesterone acetate in the treatment of menorrhagia were comparable each other, however, the efficacy of LNG-IUS was superior to both.
Estrogen plus progestin therapy and breast cancer in recently postmenopausal women.
Am J Epidemiol. 2008 May 15; 167(10): 1207-16
Prentice RL, Chlebowski RT, Stefanick ML, Manson JE, Pettinger M, Hendrix SL, Hubbell FA, Kooperberg C, Kuller LH, Lane DS, McTiernan A, Jo O'Sullivan M, Rossouw JE, Anderson GL
The Women's Health Initiative trial found a modestly increased risk of invasive breast cancer with daily 0.625-mg conjugated equine estrogens plus 2.5-mg medroxyprogesterone acetate, with most evidence among women who had previously received postmenopausal hormone therapy. In comparison, observational studies mostly report a larger risk increase. To explain these patterns, the authors examined the effects of this regimen in relation to both prior hormone therapy and time from menopause to first use of postmenopausal hormone therapy ("gap time") in the Women's Health Initiative trial and in a corresponding subset of the Women's Health Initiative observational study. Postmenopausal women with a uterus enrolled at 40 US clinical centers during 1993-1998. The authors found that hazard ratios agreed between the two cohorts at a specified gap time and time from hormone therapy initiation. Combined trial and observational study data support an adverse effect on breast cancer risk. Women who initiate use soon after menopause, and continue for many years, appear to be at particularly high risk. For example, for a woman who starts soon after menopause and adheres to this regimen, estimated hazard ratios are 1.64 (95% confidence interval: 1.00, 2.68) over a 5-year period of use and 2.19 (95% confidence interval: 1.56, 3.08) over a 10-year period of use.
Symptom reporting and quality of life in the Estonian Postmenopausal Hormone Therapy Trial.
BMC Womens Health. 2008; 8: 5
Veerus P, Fischer K, Hovi SL, Karro H, Rahu M, Hemminki E
BACKGROUND: The aim of the study was to determine the effect of postmenopausal hormone therapy on women's symptom reporting and quality of life in a randomized trial. METHODS: 1823 women participated in the Estonian Postmenopausal Hormone Therapy (EPHT) Trial between 1999 and 2004. Women were randomized to open-label continuous combined hormone therapy or no treatment, or to blind hormone therapy or placebo. The average follow-up period was 3.6 years. Prevalence of symptoms and quality of life according to EQ-5D were assessed by annually mailed questionnaires. RESULTS: In the hormone therapy arms, less women reported hot flushes (OR 0.20; 95% CI: 0.14-0.28), sweating (OR 0.56; 95% CI: 0.44-0.72), and sleeping problems (OR 0.66; 95% CI: 0.52-0.84), but more women reported episodes of vaginal bleeding (OR 19.65; 95% CI: 12.15-31.79). There was no difference between the trial arms in the prevalence of other symptoms over time. Quality of life did not depend on hormone therapy use. CONCLUSION: Postmenopausal hormone therapy decreased vasomotor symptoms and sleeping problems, but increased episodes of vaginal bleeding, and had no effect on quality of life. TRIAL REGISTRATION NUMBER: ISRCTN35338757.
Contraception. 2008 Apr; 77(4): 239-48
Johnson CC, Burkman RT, Gold MA, Brown RT, Harel Z, Bruner A, Stager M, Bachrach LK, Hertweck SP, Nelson AL, Nelson DA, Coupey SM, McLeod A, Bone HG
BACKGROUND: This analysis was conducted to assess the baseline data and design methodology within an observational longitudinal comparison of use vs. nonuse of the injectable (intramuscular) contraceptive depot medroxyprogesterone acetate (DMPA-IM) and its effect on bone mass in adolescent women. STUDY DESIGN: A prospective, observational, open-label, unmatched-cohort, safety study in females aged 11-18 years. Participants either self-selected DMPA-IM (Depo-Provera) 150 mg to be administered every 12 weeks for up to 240 weeks with a 120-week post-treatment follow-up or were nonusers (users of nonhormonal contraception or sexually abstinent) who were to be followed up for up to 360 weeks. As each participant entered the study, bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry at the lumbar spine, hip and femoral neck regions, along with total body bone mineral content; serum and urine specimens were obtained for assay of bone metabolism markers and participants' histories of parity and tobacco and alcohol use were obtained. RESULTS: A total of 389 participants were enrolled: 169 elected to begin DMPA-IM; 26 chose nonhormonal methods and 194 were abstinent. The baseline characteristics indicated significant disparities between DMPA-IM users and nonusers: compared with the nonusers, DMPA-IM users had more advanced chronologic and gynecologic ages, were more likely to have smoked, been pregnant and included more blacks. These factors would likely influence bone accretion rates independent of DMPA-IM exposure. Comparison of participant BMDs with standard reference data revealed that the study cohorts did not match reference populations closely enough to make a direct between-cohort comparative analysis feasible. CONCLUSIONS: The baseline differences in cohort characteristics preclude a meaningful comparison of mean BMD changes over time between DMPA-IM users and nonusers cohorts, and comparisons of changes in Z-scores between cohorts were also not appropriate. Therefore, within-participant BMD decreases from baseline were established as safety thresholds, and the proportion of individuals crossing those thresholds on a persistent or progressive basis was identified as the revised primary end point.
Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin.
JAMA. 2008 Mar 5; 299(9): 1036-45
Heiss G, Wallace R, Anderson GL, Aragaki A, Beresford SA, Brzyski R, Chlebowski RT, Gass M, LaCroix A, Manson JE, Prentice RL, Rossouw J, Stefanick ML,
CONTEXT: The Women's Health Initiative (WHI) trial of estrogen plus progestin vs placebo was stopped early, after a mean 5.6 years of follow-up, because the overall health risks of hormone therapy exceeded its benefits. OBJECTIVE: To report health outcomes at 3 years (mean 2.4 years of follow-up) after the intervention was stopped. DESIGN, SETTING, AND PARTICIPANTS: The intervention phase was a double-blind, placebo-controlled, randomized trial of conjugated equine estrogens (CEE) 0.625 mg daily plus medroxyprogesterone acetate (MPA) 2.5 mg daily, in 16,608 women aged 50 through 79 years, recruited by 40 centers from 1993 to 1998. The postintervention phase commenced July 8, 2002, and included 15 730 women. MAIN OUTCOME MEASURES: Semi-annual monitoring and outcomes ascertainment continued per trial protocol. The primary end points were coronary heart disease and invasive breast cancer. A global index summarizing the balance of risks and benefits included the 2 primary end points plus stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, and death due to other causes. RESULTS: The risk of cardiovascular events after the intervention was comparable by initial randomized assignments, 1.97% (annualized rate) in the CEE plus MPA (343 events) and 1.91% in the placebo group (323 events). A greater risk of malignancies occurred in the CEE plus MPA than in the placebo group (1.56% [n = 281] vs 1.26% [n = 218]; hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.04-1.48). More breast cancers were diagnosed in women who had been randomly assigned to receive CEE plus MPA vs placebo (0.42% [n = 79] vs 0.33% [n = 60]; HR, 1.27; 95% CI, 0.91-1.78) with a modest trend toward a lower HR during the follow-up after the intervention. All-cause mortality was somewhat higher in the CEE plus MPA than in the placebo group (1.20% [n = 233] vs 1.06% [n = 196]; HR, 1.15; 95% CI, 0.95-1.39). The global index of risks and benefits was unchanged from randomization through March 31, 2005 (HR, 1.12; 95% CI, 1.03-1.21), indicating that the risks of CEE plus MPA exceed the benefits for chronic disease prevention. CONCLUSIONS: The increased cardiovascular risks in the women assigned to CEE plus MPA during the intervention period were not observed after the intervention. A greater risk of fatal and nonfatal malignancies occurred after the intervention in the CEE plus MPA group and the global risk index was 12% higher in women randomly assigned to receive CEE plus MPA compared with placebo. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000611.
Am J Obstet Gynecol. 2008 Mar; 198(3): 314.e1-8
Xu H, Gonzalez JM, Ofori E, Elovitz MA
OBJECTIVE: Recent clinical trials suggest that progestational agents may prevent preterm birth, specifically in women with short cervices. These studies sought to assess novel pathways by which progestational agents (PAs) may modify signal transduction pathways that are involved in cervical ripening. STUDY DESIGN: A microarray analysis was performed on pregnant mouse cervix that was exposed to a MPA. Appropriate microarray and cluster analyses were performed. Target genes of interest were investigated in both PA- and inflammation-exposed cervices by quantitative polymerase chain reaction and immunohistochemistry. RESULTS: Microarray analysis identified both the previously recognized and novel pathways that are involved in cervical ripening. PAs differentially regulate expression of claudin-2, hyaluronan synthase 2, and lipocalin 2. Claudin expression is significantly decreased by inflammation, which is prevented by PAs. CONCLUSION: PAs significantly modulate gene expression in the cervix in the presence and absence of inflammation. The regulation of these pathways, specifically claudin proteins, may be a critical mechanism by which PAs prevent preterm birth, especially in women with premature cervical shortening.
Estrogen plus progestin and breast cancer detection by means of mammography and breast biopsy.
Arch Intern Med. 2008 Feb 25; 168(4): 370-7; quiz 345
Chlebowski RT, Anderson G, Pettinger M, Lane D, Langer RD, Gilligan MA, Gillian MA, Walsh BW, Chen C, McTiernan A,
BACKGROUND: The effect of combined hormone therapy on breast cancer detection is not established. METHODS: We examined the effect of combined hormone therapy on breast cancer detection in the Women's Health Initiative trial, which randomized 16,608 postmenopausal women to receive conjugated equine estrogens (0.625 mg/d) plus medroxyprogesterone acetate (2.5 mg/d) or placebo. Mammography and breast examinations were performed at baseline and annually per protocol, with breast biopsies based on clinical findings. The effects of conjugated equine estrogens plus medroxyprogesterone acetate on breast cancer detection was determined throughout 5.6 years of intervention using receiver operating characteristic analyses to evaluate mammography results. RESULTS: Conjugated equine estrogens plus medroxyprogesterone acetate increased the cumulative frequency of mammograms with abnormalities vs placebo (35.0% vs 23.0%; P < .001), which had less sensitivity for cancer detection and increased cumulative breast biopsy frequency (10.0% vs 6.1%; P < .001). Although breast cancers were significantly increased and were diagnosed at higher stages in the combined hormone group, biopsies in that group less frequently diagnosed cancer (14.8% vs 19.6%; P = .006). After discontinuation of combined hormone therapy, its adverse effect on mammograms modulated but remained significantly different from that of placebo for at least 12 months (P < .001). CONCLUSIONS: Use of conjugated equine estrogens plus medroxyprogesterone acetate for approximately 5 years resulted in more than 1 in 10 and 1 in 25 women having otherwise avoidable mammogram abnormalities and breast biopsies, respectively, and compromised the diagnostic performance of both. This adverse effect on breast cancer detection should be incorporated into risk-benefit discussions with women considering even short-term combined hormone therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000611.