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Title: Headache induced by the use of combined oral contraceptives.
Author: Allais G; Gabellari IC; Airola G; Borgogno P; Schiapparelli P; Benedetto C
Source: Neurological Sciences. 2009 May;30 Suppl 1:S15-7.
Abstract: Although combined oral contraceptives (COCs) are a safe and highly effective method of birth control, they may also give rise to problems of clinical tolerability in migraine patients. Indeed, headache is among the most common side effects reported with the use of COCs, frequently leading to their being discontinued. The latest International Classification of Headache Disorders identified at least two entities evidently related to the use of COCs, i.e., exogenous hormone-induced headache and estrogen-withdrawal headache. As to the former, the newest formulations of COCs are generally well tolerated by migraine without aura patients, but can worsen headache in migraine with aura patients. Headache associated with COCs, generally, tends to improve as their use continues. However, although it is not yet clear if there is an association between headache and the composition of COCs (both in the type and amount of hormones), it has been observed that the incidence of headache during COC use seems greater if migraine is associated with menstrual trigger. The estrogen-withdrawal headache is a headache that generally appears within the first 5 days after cessation of estrogen use and resolves within 3 days, even if in some cases it may appear on the sixth or seventh day after pill suspension and lasts more than 3 days.
Language: English
Keywords:
ITALY | LITERATURE REVIEW | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | HEADACHE | MIGRAINE | INCIDENCE | HORMONES | ESTROGENS | Developed Countries | Europe, Southern | Europe | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Signs and Symptoms | Diseases | Vascular Diseases | Measurement | Research Methodology | Endocrine System | Physiology | Biology
Document Number: 342617

Title: Reproductive and hormonal factors, and ovarian cancer risk for BRCA1 and BRCA2 mutation carriers: results from the International BRCA1/2 Carrier Cohort Study.
Author: Antoniou AC; Rookus M; Andrieu N; Brohet R; Chang-Claude J
Source: Cancer Epidemiology, Biomarkers and Prevention. 2009 Feb;18(2):601-10.
Abstract: BACKGROUND: Several reproductive and hormonal factors are known to be associated with ovarian cancer risk in the general population, including parity and oral contraceptive (OC) use. However, their effect on ovarian cancer risk for BRCA1 and BRCA2 mutation carriers has only been investigated in a small number of studies. METHODS: We used data on 2,281 BRCA1 carriers and 1,038 BRCA2 carriers from the International BRCA1/2 Carrier Cohort Study to evaluate the effect of reproductive and hormonal factors on ovarian cancer risk for mutation carriers. Data were analyzed within a weighted Cox proportional hazards framework. RESULTS: There were no significant differences in the risk of ovarian cancer between parous and nulliparous carriers. For parous BRCA1 mutation carriers, the risk of ovarian cancer was reduced with each additional full-term pregnancy (P trend = 0.002). BRCA1 carriers who had ever used OC were at a significantly reduced risk of developing ovarian cancer (hazard ratio, 0.52; 95% confidence intervals, 0.37-0.73; P = 0.0002) and increasing duration of OC use was associated with a reduced ovarian cancer risk (P trend = 0.0004). The protective effect of OC use for BRCA1 mutation carriers seemed to be greater among more recent users. Tubal ligation was associated with a reduced risk of ovarian cancer for BRCA1 carriers (hazard ratio, 0.42; 95% confidence intervals, 0.22-0.80; P = 0.008). The number of ovarian cancer cases in BRCA2 mutation carriers was too small to draw definitive conclusions. CONCLUSIONS: The results provide further confirmation that OC use, number of full-term pregnancies, and tubal ligation are associated with ovarian cancer risk in BRCA1 carriers to a similar relative extent as in the general population.
Language: English
Keywords:
DEVELOPED COUNTRIES | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | COHORT ANALYSIS | CROSS-CULTURAL COMPARISONS | CLINICAL RESEARCH | WOMEN | PREVALENCE | RISK ASSESSMENT | OVARIAN CANCER | CHROMOSOME ABNORMALITIES | PARITY | RISK FACTORS | ORAL CONTRACEPTIVES, SIDE EFFECTS | TUBAL LIGATION | Research Methodology | Comparative Studies | Studies | Demographic Factors | Population | Measurement | Evaluation | Cancer | Neoplasms | Diseases | Neonatal Diseases and Abnormalities | Fertility Measurements | Fertility | Population Dynamics | Health | Contraceptive Safety | Safety | Public Health | Female Sterilization | Sterilization, Sexual | Family Planning
Document Number: 331025

Title: Experience with side effects among users of injectables, the IUD, and oral contraceptive pills in four urban areas of Honduras.
Author: Barden-O'Fallon J; Speizer I; Rodriguez F; Calix J
Source: Health Care For Women International. 2009 Jun;30(6):475-83.
Abstract: Contraceptive side effects are often the most commonly reported reason for method discontinuation, particularly of modern methods. We use data from eight focus groups and 800 exit interviews to examine women's experiences with contraceptive side effects in four urban areas of Honduras. Ease of treatment and differences in motivation to avoid pregnancy are suggested explanations for why side effects cause some women to continue and others to discontinue. Although side effects are a common reason for discontinuation in this population, less than half of the surveyed women were informed about potential side effects by a health worker on the day of the interview.
Language: English
Keywords:
HONDURAS | RESEARCH REPORT | FOCUS GROUPS | URBAN AREAS | HEALTH PERSONNEL | WOMEN | ORAL CONTRACEPTIVES, SIDE EFFECTS | INJECTABLES | IUD SIDE EFFECTS | PROGRAM ACCEPTABILITY | Developing Countries | Central America | Latin America | Americas | Data Collection | Research Methodology | Geographic Factors | Population | Delivery of Health Care | Health | Demographic Factors | Contraceptive Safety | Safety | Public Health | Contraceptive Methods | Contraception | Family Planning | IUD | Program Evaluation | Programs | Organization and Administration
Document Number: 341018

Title: [Challenges of youth contraception: intersections between gender, sexuality and health] Desafios da contracepcao juvenil: intersecoes entre genero, sexualidade e saude.
Author: Brandao ER
Source: Ciencia and Saude Coletiva. 2009 Jul-Aug;14(4):1063-71.
Abstract: This qualitative paper discusses some of the difficulties young people have when dealing with contraception and also identifies circumstances in which they tend not to use contraceptive methods. The authors conducted 73 in-depth interviews with young men and women, ages 18 to 24, living in three state capitals in Brazil (Salvador, Rio de Janeiro, Porto Alegre), who went through at least one experience of teenage pregnancy. Data were analyzed by theme in order to assemble similar and repeated elements in the testimonies. The reasons young people have difficulty adopting continued use of contraceptive methods were listed according to the following themes: relationship context; relationship with the family regarding sexuality; side effects of hormonal contraceptive methods; negligence with contraception; problems with health services; failure of contraceptive methods; a strong sense of fatherhood; use of condoms with unknown female partners; and use of withdrawal with no knowledge of the partner�s menstrual cycle.
Language: Portuguese
Keywords:
BRAZIL | RESEARCH REPORT | QUALITATIVE RESEARCH | INTERVIEWS | YOUTH | SEXUALITY | ADOLESCENT PREGNANCY | CONTRACEPTION | ORAL CONTRACEPTIVES, SIDE EFFECTS | INTERPERSONAL RELATIONS | SEX BEHAVIOR | South America, Eastern | South America | Latin America | Americas | Developing Countries | Research Methodology | Data Collection | Age Factors | Population Characteristics | Demographic Factors | Population | Personality | Psychological Factors | Behavior | Reproductive Behavior | Fertility | Population Dynamics | Family Planning | Contraceptive Safety | Safety | Public Health | Health
Document Number: 342619

Title: Progestogen-only contraceptives and the risk of stroke: a meta-analysis.
Author: Chakhtoura Z; Canonico M; Gompel A; Thalabard JC; Scarabin PY; Plu-Bureau G
Source: Stroke; A Journal of Cerebral Circulation. 2009 Apr;40(4):1059-62.
Abstract: BACKGROUND AND PURPOSE: The association between combined oral contraceptives (OC) use and increased risk of stroke has been reported. While progestogen-only contraceptives (POC) are commonly used worldwide, their impact on cardiovascular disease remains unclear. METHODS: A meta-analysis based on EMBASE and MEDLINE referenced literature corresponding to OCs marketed since 1960 was carried out. Eligible articles assessing the risk of stroke in relation to OC or POC were reviewed, and relevant studies were extracted. All types of POC and routes of administration were taken into account in the meta-analysis. RESULTS: Six case-control studies were identified. The combined odd ratio (OR) showed no increase in the risk of stroke among POC users (OR=0.96; 95% confidence interval: 0.70 to 1.31). This result was similar according to the route of administration (either implant or injectable or oral POC). CONCLUSIONS: Data from observational studies show that POC use is not associated with an increased risk of stroke. However, these results are based on limited data. Further investigations are needed in women with risk factors of stroke.
Language: English
Keywords:
FRANCE | LITERATURE REVIEW | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | CASE CONTROL STUDIES | COMPARATIVE STUDIES | WOMEN | PREVALENCE | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE AGENTS, PROGESTIN | RISK ASSESSMENT | CEREBROVASCULAR EFFECTS | CONTRACEPTIVE IMPLANTS | INJECTABLES | Developed Countries | Europe, Western | Europe | Research Methodology | Studies | Demographic Factors | Population | Measurement | Contraceptive Safety | Safety | Public Health | Health | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Evaluation | Physiology | Biology | Contraceptive Methods
Document Number: 331085

Title: Recent oral contraceptive use and adverse birth outcomes.
Author: Chen XK; Wen SW; Sun LM; Yang Q; Walker MC
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology. 2009;144:40-43.
Abstract: OBJECTIVE: To examine the possible association between oral contraceptive use and adverse birth outcomes. STUDY DESIGN: We conducted a population-based cohort study of pregnant women who used oral contraceptives within 3 months before their last menstrual period. Subjects were divided into three groups, according to the interval (0-30, 31-60, and 61-90 days) between the dispensing date and their last menstrual period. For each exposed subject, 4 subjects without exposure to oral contraceptives were individually matched by infant's year of birth and plurality and by mother's age and parity. RESULTS: Oral contraceptive use within 30 days prior to the last menstrual period was associated with increased risks of very low birth weight (OR: 3.24, 95% CI: 1.18, 8.92), low birth weight (OR: 1.93, 95% CI: 1.17, 3.20), and preterm birth (OR: 1.61, 95% CI: 1.01, 2.55); however, oral contraceptive use 31-90 days prior to the last menstrual period did not increase the risk of low birth weight or preterm birth.CONCLUSION: Our results indicate the use of oral contraceptives near the time of conception may be associated with an increased risk of low birth weight and preterm birth.
Language: English
Keywords:
CANADA | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | COHORT ANALYSIS | CLINICAL RESEARCH | INFANT | PREGNANT WOMEN | PREVALENCE | PREGNANCY OUTCOMES | ORAL CONTRACEPTIVES, SIDE EFFECTS | TIME FACTORS | LOW BIRTH WEIGHT | PREMATURE BIRTH | RISK FACTORS | North America, Northern | Americas | Developed Countries | Research Methodology | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Measurement | Pregnancy | Reproduction | Contraceptive Safety | Safety | Public Health | Health | Population Dynamics | Birth Weight | Body Weight | Physiology | Biology
Document Number: 330420

Peer Reviewed

Title: Effects of oral contraception with ethinylestradiol and drospirenone on oxidative stress in women 18-35 years old.
Author: De Groote D; d'Hauterive SP; Pintiaux A; Balteau B; Gerday C; Claesen J; Foidart JM
Source: Contraception. 2009 Aug;80(2):187-93.
Abstract: BACKGROUND: Oral contraceptives (OCs) with estrogens and progestins may affect oxidative stress (OS) status. STUDY DESIGN: A group of 32 women using oral contraceptives (OCU) containing 0.03 mg ethinylestradiol and 3 mg drospirenone have been compared to a matched control group of 30 noncontraception users (NCU). Blood levels of antioxidants, trace elements and markers of lipid peroxidation were assessed by biochemical methods. A microarray analysis of whole blood mRNA levels of 200 genes involved in OS-dependant pathway was also performed. RESULTS: Levels of zinc, vitamin E and antibodies to oxidized low-density lipoproteins (LDLs) were not significantly different between the two groups. On the other hand, significant increases in the mean levels of lipid peroxides (+176%, p<.001), oxidized LDLs (+145%, p<.002), copper (+103%, p<.001), Cu/Zn ratio (+100%, p<.001) and a significant decrease in the mean level of beta-carotene (-41%, p<.01) were observed in the OCU compared to NCU. There was a highly significant positive correlation between the lipid peroxide levels and the copper-to-zinc ratio. From the 200 genes tested by microarray, one coding for HSP70 was significantly up-regulated (log(2) fold change=+ 0.45, p<.02) and one coding for inducible nitric oxide synthase significantly down-regulated (log(2) fold change=-0.24, p<.05) in the OCU compared to the NCU. CONCLUSIONS: The recently introduced combination of ethinylestradiol and drospirenone induced the heightening of lipid peroxidation correlated with high levels of copper, a situation that could be associated with increased cardiovascular risk.
Language: English
Keywords:
BELGIUM | RESEARCH REPORT | CONTROL GROUPS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | LOW-DOSE PROGESTINS | ORAL CONTRACEPTIVES, SIDE EFFECTS | METABOLIC EFFECTS | CARDIOVASCULAR EFFECTS | SERUM COPPER LEVEL | Europe, Western | Europe | Developed Countries | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Progestin | Contraceptive Safety | Safety | Public Health | Health | Physiology | Biology | Hemic System
Document Number: 342303

Peer Reviewed

Title: Pill scare: communication conundrum.
Author: Edouard L
Source: Journal of Family Planning and Reproductive Health Care. 2009 Apr;35(2):121-2.
Abstract: Adverse publicity for combined oral contraceptives (COCs) has led to pill scares on numerous occasions such as reproductive cancers in 1983 and venous thromboembolism (VTE) in 1995. Misinformation should be avoided, especially through the correct interpretation of relative risk to avoid confusion and decrease unnecessary anxiety. Reassurance is usually important, as the absolute risk is infinitely small. The popular media are very effective for the prompt dissemination of information, and authoritative statements are useful for improving communications with providers, patients and public.
Language: English
Keywords:
ALGERIA | HISTORICAL REVIEW | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | MISINFORMATION | FEAR | RISK ASSESSMENT | CANCER | THROMBOEMBOLISM | INFORMATION DISTRIBUTION | PUBLIC HEALTH | Africa, North | Africa | Developing Countries | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Health | Communication | Emotions | Psychological Factors | Behavior | Evaluation | Neoplasms | Diseases | Embolism | Vascular Diseases
Document Number: 341650

10.

Title: Oral contraceptives for functional ovarian cysts.
Author: Grimes DA; Jones LB; Lopez LM; Schulz KF
Source: Cochrane Database of Systematic Reviews. 2009;(2):CD006134.
Abstract: BACKGROUND: Functional ovarian cysts are a common gynecological problem among women of reproductive age worldwide. When large, persistent, or painful, these cysts may require operations, sometimes resulting in removal of the ovary. Since early oral contraceptives were associated with a reduced incidence of functional ovarian cysts, many clinicians inferred that birth control pills could be used to treat cysts as well. This became a common clinical practice in the early 1970s. OBJECTIVES: This review examined all randomized controlled trials that studied oral contraceptives as therapy for functional ovarian cysts. SEARCH STRATEGY: We searched the databases of CENTRAL, MEDLINE, POPLINE, and EMBASE, as well as clinical trials databases (ClinicalTrials.gov and ICTRP). We also examined the reference lists of articles and wrote to authors of identified trials to seek articles we had missed. SELECTION CRITERIA: We included randomized controlled trials in any language that included oral contraceptives used for treatment and not prevention of functional ovarian cysts. Criteria for diagnosis of cysts were those used by authors of trials. DATA COLLECTION AND ANALYSIS: Two authors independently abstracted data from the articles. One entered the data into RevMan and a second verified accuracy of data entry. For dichotomous outcomes, we used Peto odds ratios with 95% confidence intervals (CI). For continuous outcomes, we calculated mean differences with 95% CI. MAIN RESULTS: We identified seven randomized controlled trials from four countries; the studies included a total of 500 women. Treatment with combined oral contraceptives did not hasten resolution of functional ovarian cysts in any trial. This held true for cysts that occurred spontaneously as well as those that developed after ovulation induction. Most cysts resolved without treatment within a few cycles; persistent cysts tended to be pathological (e.g., endometrioma or para-ovarian cyst) and not physiological. AUTHORS' CONCLUSIONS: Although widely used fortreating functional ovarian cysts, combined oral contraceptives appear to be of no benefit. Watchful waiting for two or three cycles is appropriate. Should cysts persist, surgical management is often indicated.
Language: English
Keywords:
LITERATURE REVIEW | CLINICAL TRIALS | WOMEN | OVARIAN CYSTS | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | TREATMENT | Clinical Research | Research Methodology | Demographic Factors | Population | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Medical Procedures | Medicine | Health Services | Delivery of Health Care
Document Number: 330972

11.

Title: [Weight gain due to hormonal contraception: myth or truth?] Gewichtsveranderung unter hormonalen Kontrazeptiva: Mythos oder Wahrheit?
Author: Hani D; Imthurn B; Merki-Feld GS
Source: Gynakologisch - Geburtshilfliche Rundschau. 2009;49(2):87-93.
Abstract: Weight gain is one of the side effects often attributed to the use of hormonal contraception. Concern about weight gain can hinder particularly young women to use a safe contraceptive method or may be a reason for early discontinuation. In the following review, we present studies examining the influence of different contraceptive methods on weight change and discuss the results and methodological problems. During use of hormonal contraceptives, weight fluctuates by about 3 kg over an observation interval from 6 to 24 months. Only in a subgroup of Depo Provera users is the increase in weight higher: the proportion of women gaining >3 kg/year is higher compared with the other hormonal contraceptives. Interestingly users of intrauterine devices experience a weight gain too, which is approximately double that of the average female population. The age-associated weight gain has been described to be 0.1 kg/m(2) annually, corresponding to about 300 g/year.
Language: German
Keywords:
RESEARCH REPORT | RESEARCH METHODOLOGY | WOMEN | BODY WEIGHT | ORAL CONTRACEPTIVES, SIDE EFFECTS | Demographic Factors | Population | Physiology | Biology | Contraceptive Safety | Safety | Public Health | Health
Document Number: 330951

12.

Title: Estradiol valerate/dienogest: in oral contraception.
Author: Hoy SM; Scott LJ
Source: Drugs. 2009;69(12):1635-46.
Abstract: Estradiol valerate/dienogest is an oral contraceptive for women that combines the natural estrogen estradiol with the 19-nortestosterone derivative dienogest in a four-phasic formulation. black triangle Estradiol valerate/dienogest demonstrated contraceptive efficacy in a large (n = 1377), noncomparative, multicentre study in women aged 18-50 years, with 13 pregnancies over 1797.5 women-years of exposure generating an unadjusted Pearl Index (PI) of 0.73 (upper limit of 95% CI 1.24) [primary endpoint]. Six of the pregnancies were attributed to method failure, resulting in an adjusted PI, based on 1786.5 women-years of exposure, of 0.34 (upper limit of 95% CI 0.73). black triangle In a double-blind study in 798 women aged 18-50 years, estradiol valerate/dienogest and ethinylestradiol/levonorgestrel demonstrated an acceptable bleeding pattern and level of cycle control, according to several co-primary endpoints. black triangle As reported in the UK manufacturer's summary of product characteristics, the unadjusted PI for women aged 18-35 years or 18-50 years in a pooled analysis of clinical studies was 1.01 (upper limit of 95% CI 1.59) and 0.79 (upper limit of 95% CI 1.23). This pooled analysis of three studies excluded those pregnancies occurring within 14 days of the cessation of therapy. black triangle Estradiol valerate/dienogest was generally well tolerated in this population, with the nature of adverse events generally similar across the studies and between estradiol valerate/dienogest and ethinylestradiol/levonorgestrel.
Language: English
Keywords:
UNITED KINGDOM | LITERATURE REVIEW | ORAL CONTRACEPTIVES, PHASIC | ORAL CONTRACEPTIVES, SIDE EFFECTS | ADMINISTRATION AND DOSAGE | ESTRADIOL | LOW-DOSE PROGESTINS | CONTRACEPTIVE EFFECTIVENESS | PEARL'S FORMULA | MENSTRUAL CYCLE | Developed Countries | Europe, Western | Europe | Oral Contraceptives, Combined | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Estrogens | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Use-Effectiveness | Menstruation | Reproduction
Document Number: 342469

13.

Title: Spontaneous hepatic hemorrhage secondary to prolonged use of oral contraceptives.
Author: Jaffar R; Pechet L; Whalen GF; Banner BF
Source: Pathology, Research and Practice. 2009 Jul 3;
Abstract: Oral contraceptive pills (OCP) are the most commonly used form of contraception throughout the United States of America. The prolonged usage of oral contraceptives leads to a variety of complications, ranging from subclinical modifications of liver function tests to the development of benign and malignant tumors of the liver. Spontaneous hepatic hemorrhage secondary to oral contraceptive use was only reported once in the early 1980s. We report a case of spontaneous hepatic hemorrhage secondary to prolonged ingestion of combined OCPs followed by multiple pulmonary emboli without underlying thrombophilia.
Language: English
Keywords:
UNITED STATES OF AMERICA | SUMMARY REPORT | CASE HISTORIES | ORAL CONTRACEPTIVES, SIDE EFFECTS | ADMINISTRATION AND DOSAGE | HEPATIC EFFECTS | BLEEDING | HEMATOMA | PULMONARY EMBOLISM | SURGERY | Developed Countries | North America | Americas | Data Collection | Research Methodology | Contraceptive Safety | Safety | Public Health | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Physiology | Biology | Signs and Symptoms | Diseases | Embolism | Vascular Diseases
Document Number: 341974

14.

15.

Peer Reviewed

Title: Adding low-dose estrogen to the hormone-free interval: impact on bleeding patterns in users of a 91-day extended regimen oral contraceptive.
Author: Kaunitz AM; Portman DJ; Hait H; Reape KZ
Source: Contraception. 2009 May;79(5):350-5.
Abstract: BACKGROUND: A cross-study analysis of contraceptive clinical trials for two different 91-day oral contraceptive (OC) regimens was performed to examine the impact on bleeding patterns when supplementing the 7-day hormone-free interval with 10 mcg ethinyl estradiol (EE) daily. STUDY DESIGN: Two separate 1-year Phase 3 clinical programs were conducted using similar study designs. The percentages of subjects reporting bleeding and spotting using electronic diaries for each 91-day cycle were compared. RESULTS: Scheduled bleeding with the EE regimen was less than that reported with the regimen utilizing placebo during Days 85-91, with significant differences noted for all four 91-day cycles. Unscheduled bleeding decreased more quickly with the 91-day regimen containing low-dose EE in place of placebo, with significant differences noted during the third cycle. CONCLUSIONS: This cross-study comparison suggests that the administration of low-dose estrogen in place of placebo in a 91-day extended regimen OCimproves the bleeding profile.
Language: English
Keywords:
NORTH AMERICA, NORTHERN | LITERATURE REVIEW | CLINICAL TRIALS | WOMEN | BLEEDING | ORAL CONTRACEPTIVES, SIDE EFFECTS | ORAL CONTRACEPTIVES, LOW-DOSE | CONTRACEPTIVE AGENTS, ESTROGEN | TIME FACTORS | ADMINISTRATION AND DOSAGE | ETHINYL ESTRADIOL | Americas | Developed Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Signs and Symptoms | Diseases | Contraceptive Safety | Safety | Public Health | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Population Dynamics | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care
Document Number: 330939

16.

Peer Reviewed

Title: Adrenal glucocorticoid and androgen precursor dissociation in anorexia nervosa.
Author: Lawson EA; Misra M; Meenaghan E; Rosenblum L; Donoho DA; Herzog D; Klibanski A; Miller KK
Source: Journal of Clinical Endocrinology and Metabolism. 2009 Apr;94(4):1367-71.
Abstract: CONTEXT: Anorexia nervosa is characterized by hypogonadism and relative hypercortisolemia. We have demonstrated that free testosterone levels are low in women with anorexia nervosa, with the lowest levels in those receiving oral contraceptives (OCPs), and that dehydroepiandrosterone (DHEA) sulfate is reduced only in those receiving OCPs. OBJECTIVE: The aim of the study was to determine whether adrenal steroidogenesis dysregulation contributes to decreased androgen levels in anorexia nervosa. Design and Setting: We conducted a cross-sectional study in a General Clinical Research Center. STUDY PARTICIPANTS: We studied 20 women with anorexia nervosa [10 women with anorexia nervosa receiving OCPs (AN+E) and 10 not receiving OCPs (AN-E)] and 20 healthy controls [10 healthy controls receiving OCPs (HC+E) and 10 not receiving OCPs (HC-E)]. MAIN OUTCOME MEASURES: We measured DHEA and cortisol levels in response to 250-microg cosyntropin stimulation after 1-mg overnight dexamethasone suppression. RESULTS: Mean basal and stimulated, peak stimulated, and area under the curve (AUC) cortisol levels were higher in AN-E than HC-E, but mean basal and stimulated, peak and AUC DHEA were comparable. Mean AUC and peak cortisol were higher and DHEA AUC was lower in AN+E than AN-E. However, after controlling for cortisol binding globulin levels, peak and AUC cortisol were comparable between AN+E and AN-E. After controlling for albumin levels, AUC DHEA was comparable between AN+E and AN-E. CONCLUSIONS: Adrenal glucocorticoid and androgen precursor secretion are dissociated in anorexia nervosa, with relative hypercortisolemia and a preservation of DHEA secretion. Reduced DHEA response to cosyntropin in women receiving OCPs is attributable to decreased albumin levels. In the setting of relative hypercortisolemia, reduced adrenal androgen precursor secretion is not a mechanism underlying low testosterone levels in anorexia nervosa.
Language: English
Keywords:
MASSACHUSETTS | RESEARCH REPORT | CLINICAL RESEARCH | CROSS SECTIONAL ANALYSIS | CASE CONTROL STUDIES | WOMEN | DEFICIENCY DISEASES | BODY WEIGHT | TESTOSTERONE | ORAL CONTRACEPTIVES, SIDE EFFECTS | DEHYDROEPIANDROSTERONE | ANDROGENS | DEXAMETHASONE ACETATE | United States of America | North America | Americas | Developed Countries | Research Methodology | Studies | Demographic Factors | Population | Nutrition Disorders | Diseases | Physiology | Biology | Hormones | Endocrine System | Contraceptive Safety | Safety | Public Health | Health
Document Number: 341132

17.

Peer Reviewed

Title: Early weight gain predicting later weight gain among depot medroxyprogesterone acetate users.
Author: Le YC; Rahman M; Berenson AB
Source: Obstetrics and Gynecology. 2009 Aug;114(2 Pt 1):279-84.
Abstract: OBJECTIVE:: To examine if early weight gain in depot medroxyprogesterone acetate (DMPA) users predicts continued excessive weight gain and to identify risk factors of early weight gain in DMPA users. METHODS:: Depot medroxyprogesterone acetate users (N=240) were assessed before initiating contraception and every 3 months for 36 months. Early weight gain was defined as more than 5% baseline weight gain within 6 months of DMPA use. Mean weight gain at 6-month intervals was estimated based on early weight gain status (at or below 5% gain compared with above 5% gain). Multiple logistic and mixed-model regression analyses were used. RESULTS:: About one-fourth of DMPA users had early weight gain. The mean weight gain of the at or below 5% group and above 5% group was 0.63 kg and 8.04 kg, 1.48 kg and 10.86 kg, and 2.49 kg and 11.08 kg after 12, 24, and 36 months (P<.001 at all observations), respectively. Early weight gainers also had a much steeper slope of weight gain over time than the regular weight gainers (0.35 kg/month compared with 0.08 kg/month, P<.001). Risk factors for early weight gain were body mass index less than 30 (odds ratio [OR] 4.00, 95% confidence interval [CI] 1.513-10.455), parity (OR 2.23, 95% CI:1.040-4.761), and self-reported increased appetite after 6 months of DMPA use (OR 3.06, 95% CI 1.505-6.214). CONCLUSION:: Most DMPA users who gain excessive weight experience more than a 5% weight increase within 6 months. These data help physicians predict who is at risk of excessive gain and counsel them appropriately. LEVEL OF EVIDENCE:: II.
Language: English
Keywords:
UNITED STATES OF AMERICA | TEXAS | RESEARCH REPORT | WOMEN | MEDROXYPROGESTERONE ACETATE | ORAL CONTRACEPTIVES, SIDE EFFECTS | BODY WEIGHT | RISK FACTORS | Developed Countries | North America | Americas | Demographic Factors | Population | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Physiology | Biology
Document Number: 342271

18.
Title: Hormonal contraception and risk of venous thromboembolism: national follow-up study.
Author: Lidegaard O; Lokkegaard E; Svendsen AL; Agger C
Source: BMJ. 2009;339:b2890.
Abstract: OBJECTIVE: To assess the risk of venous thrombosis in current users of different types of hormonal contraception, focusing on regimen, oestrogen dose, type of progestogen, and route of administration. DESIGN: National cohort study. SETTING: Denmark, 1995-2005. PARTICIPANTS: Danish women aged 15-49 with no history of cardiovascular or malignant disease. MAIN OUTCOME MEASURES: Adjusted rate ratios for all first time deep venous thrombosis, portal thrombosis, thrombosis of caval vein, thrombosis of renal vein, unspecified deep vein thrombosis, and pulmonary embolism during the study period. RESULTS: 10.4 million woman years were recorded, 3.3 million woman years in receipt of oral contraceptives. In total, 4213 venous thrombotic events were observed, 2045 in current users of oral contraceptives. The overall absolute risk of venous thrombosis per 10 000 woman years in non-users of oral contraceptives was 3.01 and in current users was 6.29. Compared with non-users of combined oral contraceptives the rate ratio of venous thrombembolism in current users decreased with duration of use (<1 year 4.17, 95% confidence interval 3.73 to 4.66, 1-4 years 2.98, 2.73 to 3.26, and >4 years 2.76, 2.53 to 3.02; P<0.001) and with decreasing dose of oestrogen. Compared with oral contraceptives containing levonorgestrel and with the same dose of oestrogen and length of use, the rate ratio for oral contraceptives with norethisterone was 0.98 (0.71 to 1.37), with norgestimate 1.19 (0.96 to 1.47), with desogestrel 1.82 (1.49 to 2.22), with gestodene 1.86 (1.59 to 2.18), with drospirenone 1.64 (1.27 to 2.10), and with cyproterone 1.88 (1.47 to 2.42). Compared with non-users of oral contraceptives, the rate ratio for venous thromboembolism in users of progestogen only oral contraceptives with levonorgestrel or norethisterone was 0.59 (0.33 to 1.03) or with 75 mug desogestrel was 1.12 (0.36 to 3.49), and for hormone releasing intrauterine devices was 0.90 (0.64 to 1.26). CONCLUSION: The risk of venous thrombosis in current users of combined oral contraceptives decreases with duration of use and decreasing oestrogen dose. For the same dose of oestrogen and the same length of use, oral contraceptives with desogestrel, gestodene, or drospirenone were associated with a significantly higher risk of venous thrombosis than oral contraceptives with levonorgestrel. Progestogen only pills and hormone releasing intrauterine devices were not associated with any increased risk of venous thrombosis.
Language: English
Keywords:
DENMARK | RESEARCH REPORT | COHORT ANALYSIS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | ADMINISTRATION AND DOSAGE | THROMBOEMBOLISM | RISK FACTORS | THROMBOSIS | PULMONARY EMBOLISM | ESTROGENS | PROGESTATIONAL HORMONES | Developed Countries | Europe, Northern | Europe | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Embolism | Vascular Diseases | Diseases | Hormones | Endocrine System | Physiology | Biology
Document Number: 342468

19.

Title: Oral contraceptives containing drospirenone for premenstrual syndrome.
Author: Lopez LM; Kaptein AA; Helmerhorst FM
Source: Cochrane Database of Systematic Reviews. 2009;(2):CD006586.
Abstract: BACKGROUND: Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of PMS. Combined oral contraceptives (COCs), which have both progestin and estrogen, have been examined for their ability to relieve premenstrual symptoms. A COC containing drospirenone and low estrogen has been approved for treating PMDD in women who choose COCs for contraception. OBJECTIVES: To review all randomized controlled trials comparing combined oral contraceptives containing drospirenone versus a placebo or another COC for effect on premenstrual symptoms. SEARCH STRATEGY: We searched the computerized databases MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, PsycINFO, and CINAHL for studies of drospirenone and premenstrual syndrome. We also examined references lists of relevant articles, and wrote to known investigators to find other trials. SELECTION CRITERIA: We included randomized controlled trials in any language that compared a COC containing drospirenone versus a placebo or another COC for effect on premenstrual symptoms. Primary outcome was the prospective recording of premenstrual symptoms (affective and physical). Adverse events related to COC use were examined. DATA COLLECTION AND ANALYSIS: Two review authors independently abstracted data and assessed study quality. MAIN RESULTS: We included five trials with a total of 1600 women. Two placebo-controlled trials of women with PMDD showed less severe premenstrual symptoms after three months with drospirenone (plus ethinyl estradiol (EE) 20g) than with the placebo (WMD -7.83; 95% CI -10.91 to -4.75). The drospirenone group had greater decreases in impairment of productivity (WMD -0.42; 95% CI -0.64 to -0.20), social activities (WMD -0.39; 95% CI -0.62 to -0.15), and relationships (WMD -0.38; 95% CI -0.61 to -0.51). Side effects more common with COC use were nausea, intermenstrual bleeding, and breast pain. Little effect was found on less severe symptoms when comparing drospirenone plus more estrogen to another COC. A six-monthstudy showed fewer symptoms with drospirenone, while a two-year trial found the groups to be similar. AUTHORS' CONCLUSIONS: Drospirenone plus EE 20 mug may help treat premenstrual symptoms in women with PMDD. The placebo also had a large effect. We do not know whether the COC works after three cycles, for women with less severe symptoms, or better than other COCs. Larger and longer trials of higher quality are needed to address these issues. Trials should follow CONSORT reporting guidelines.
Language: English
Keywords:
LITERATURE REVIEW | CONTROL GROUPS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE AGENTS, ESTROGEN | PREMENSTRUAL TENSION | CONTRACEPTIVE AGENTS, PROGESTIN | ORAL CONTRACEPTIVES, SIDE EFFECTS | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Menstruation Disorders | Diseases | Contraceptive Safety | Safety | Public Health | Health
Document Number: 330971

20.

Title: Voice onset time in women as a function of oral contraceptive use.
Author: Morris RJ; Gorham-Rowan MM; Herring KD
Source: Journal of Voice. 2009 Jan;23(1):114-8.
Abstract: Previous studies of the effect of hormonal changes across phases of the menstrual cycle on voice onset time (VOT) have not considered the variable of oral contraceptive use. The purpose of this study was to examine both the effects of menstrual cycle phase and that of oral contraceptive use on VOT. It was hypothesized that women taking oral contraceptives would exhibit smaller VOT differences across the phases of their menstrual cycles. The study was a prospective matched-group experimental design. Participants were 10 women who were on oral contraceptives and 10 who were not. The participants were recorded over two menstrual cycles, on the 10th and 20th day to evaluate their speech during the preovulation and premenstrual phases of their menstrual cycle. Participants produced 10 repetitions of the phrase "Speak ___ to me" containing the target syllables /bae/ and /pae/. Repeated measure ANOVAs revealed no significant differences in VOT between the two groups. Statistical results showed significant interactions between the menstrual cycle phase and the 2 recording months. It is possible that month-to-month differences in hormonal levels and other factors that can affect speech may have a greater effect on VOT than either the taking of oral contraceptives or the phase differences within a menstrual cycle.
Language: English
Keywords:
FLORIDA | RESEARCH REPORT | CLINICAL RESEARCH | PROSPECTIVE STUDIES | CASE CONTROL STUDIES | MATCHED GROUPS | WOMEN | ORAL CONTRACEPTIVES, SIDE EFFECTS | MENSTRUAL CYCLE | Developed Countries | United States of America | North America | Americas | Research Methodology | Studies | Control Groups | Demographic Factors | Population | Contraceptive Safety | Safety | Public Health | Health | Menstruation | Reproduction
Document Number: 331291

21.

Title: Symptomatic ileofemoral DVT after onset of oral contraceptive use in women with previously undiagnosed May-Thurner Syndrome.
Author: Murphy EH; Davis CM; Journeycake JM; Demuth RP; Arko FR
Source: Journal of Vascular Surgery. 2009 Mar;49:697-703.
Abstract: OBJECTIVE: May-Thurner syndrome is characterized by left common iliac obstruction secondary to compression of the left iliac vein by the right common iliac artery against the fifth-lumbar vertebra. This anatomic variant results in an increased incidence of left-sided deep venous thrombosis (DVT). Furthermore, while a preponderance of left-sided DVT has been demonstrated in women during pregnancy and oral contraceptive use, patients are not typically screened for this condition after developing a left-sided DVT. As anticoagulation alone is ineffective for DVT treatment in the setting of May-Thurner anatomy, more aggressive treatment is warranted. Failure to diagnosis this condition predisposes these women to the unnecessary risks of recurrent DVT and post-thrombotic syndrome. METHODS: We present the occurrence of 7 adolescent patients with previously undiagnosed May-Thurner syndrome who presented with DVT after the initiation of oral contraceptive steroids (OCP) use. All 7 patients elected to proceed with mechanical thrombolysis/catheter based thrombolysis followed by endovascular stenting and were postoperatively treated with 6 months of warfarin. RESULTS: Mean patient age was 18.3 +/- 3.3 years (range, 16-24 years). Mean time to presentation after initiation of OCP was 5 weeks (range, 2-10 weeks). Mean time to intervention was 16.8 days (range, 10-24 days). All patients were treated with mechanical thrombectomy. Our rate of intraoperative clot resolution was 100%. All 7 patients were treated with self expanding nitinol stents after angioplasty of the iliac vein stenosis with resolution of the stenotic segment. Primary stent patency is 100% (7/7). Mean follow-up time is 13 +/- 13.84 months (range, 6-42 months). There have been no long-term complications related to surgical treatment or anticoagulation. All 7 patients have experienced resolution of left leg swelling and pain and have no evidence of post-thrombotic syndrome or DVT recurrence to date. CONCLUSIONS: Women on OCPs presenting with left-sidediliofemoral DVT should be screened for hypercoagulable disorders and underlying May-Thurner anatomy. Treatment of May-Thurner syndrome should include thrombolysis/thrombectomy and anticoagulation for current DVT in addition to angioplasty and stenting of the underlying obstruction.
Language: English
Keywords:
TEXAS | RESEARCH REPORT | CLINICAL RESEARCH | ADOLESCENTS, FEMALE | VASCULAR DISEASES | ORAL CONTRACEPTIVES, SIDE EFFECTS | THROMBOSIS | TIME FACTORS | TREATMENT | SURGERY | BLOOD COAGULATION EFFECTS | EDEMA | PAIN | United States of America | North America | Americas | Developed Countries | Research Methodology | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Diseases | Contraceptive Safety | Safety | Public Health | Health | Thromboembolism | Embolism | Population Dynamics | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Hematological Effects | Hemic System | Physiology | Biology | Signs and Symptoms
Document Number: 329670

22.

Title: Maternal Use of Oral Contraceptives During Early Pregnancy and Risk of Hypospadias in Male Offspring.
Author: Norgaard M; Wogelius P; Pedersen L; Rothman KJ; Sorensen HT
Source: Urology. 2009 Jul 8;
Abstract: OBJECTIVES: To examine the association between maternal use of oral contraceptives in early pregnancy and increased prevalence of hypospadias in male offspring. METHODS: We conducted a nationwide population-based case-control study using data from nationwide medical databases. Among live male births between January 1, 1996, and December 31, 2005, we identified all cases of hypospadias recorded anytime postpartum (n = 1683) and randomly selected 10 controls per case without such a diagnosis (n = 15 650), matched by year and hospital of birth. We used conditional logistic regression to estimate prevalence ratios stratified according to time of diagnosis (within 6 months postpartum, >6 months postpartum), controlling for potential confounding factors including maternal age, birth order, maternal smoking, prescriptions for ovulation-inducing drugs, antiepileptics, and antidiabetics, and a maternal diagnosis of pre-eclampsia. RESULTS: We included 1683 cases of hypospadias and 15 650 population controlsduring 1996-2005. Among the 1186 boys who had their hypospadias diagnosis recorded within 6 months postpartum, 28 (2.4%) had been exposed to oral contraceptives between 30 days before conception until the end of the first trimester. Among the controls, 307 (2.8%) were similarly exposed, corresponding to a prevalence ratio of 0.85 (95% CI: 0.57-1.27) after adjusting for possible confounders. For a diagnosis registered >6 months postpartum, the adjusted prevalence ratio was 1.12 (95% CI: 0.61-2.06). CONCLUSIONS: Our data do not support the hypothesis that maternal use of oral contraceptives around conception is associated with an increased prevalence of hypospadias in the offspring.
Language: English
Keywords:
DENMARK | RESEARCH REPORT | CONTROL GROUPS | STATISTICAL REGRESSION | INFANT | BIRTH DEFECTS | GENITAL EFFECTS, MALE | UROGENITAL EFFECTS | PREVALENCE | RISK FACTORS | ORAL CONTRACEPTIVES, SIDE EFFECTS | PREGNANCY, FIRST TRIMESTER | Developed Countries | Europe, Northern | Europe | Research Methodology | Data Analysis | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Neonatal Diseases and Abnormalities | Diseases | Genitalia, Male | Genitalia | Urogenital System | Physiology | Biology | Measurement | Health | Contraceptive Safety | Safety | Public Health | Pregnancy | Reproduction
Document Number: 342127

23.

24.

Title: Putting a finger on potential predictors of oral contraceptive side effects: 2D:4D and middle-phalangeal hair.
Author: Oinonen KA
Source: Psychoneuroendocrinology. 2009;34:713-726.
Abstract: Many women experience emotional or physical side effects when taking oral contraceptives (OCs). Despite the potential impact on women's health and well-being, there are no valid methods to screen women for their risk of OC side effects. The present paper presents the results of two studies where anthropometric indicators of androgen exposure, 2D:4D and middle-phalangeal hair, were examined for their potential as predictors of OC side effects. In study 1, 2D:4D was associated with women's reports of a history of: (a) negative mood side effects; (b) discontinuation due to negative mood side effects; (c) specific mood side effects (i.e., crying, sadness, and altered trust in one's partners) and (d) specific physical side effects (i.e., headaches, fatigue, and decreased sex drive). In study 2, 2D:4D and/or middle-phalangeal hair was/were associated with a reported history of: (a) discontinuation due to negative mood side effects; (b) specific mood-related side effects (i.e., negative mood, disrupted sleep, increased aggression, and altered trust in one's partner) and (c) specific physical side effects (i.e., headaches, decreased menstrual cramps, and increased sex drive/arousal). The general pattern was that adverse OC side effects were experienced by women with lower 2D:4D and fewer middle-phalangeal hairs. Almost all relationships remained significant when response bias was controlled. These results suggest a possible role for prenatal testosterone exposure and both androgen action and sensitivity in women's experience of OC side effects. Furthermore, these two digit measures may be useful predictors of hormonal contraceptive side effects in women.
Language: English
Keywords:
CANADA | RESEARCH REPORT | WOMEN | SEXUAL PARTNERS | ORAL CONTRACEPTIVES, SIDE EFFECTS | ANTHROPOMETRY | ANDROGENS | SCREENING | EMOTIONS | HEADACHE | FATIGUE | CONTRACEPTION TERMINATION | SLEEPING | TESTOSTERONE | North America, Northern | Americas | Developed Countries | Demographic Factors | Population | Sex Behavior | Behavior | Contraceptive Safety | Safety | Public Health | Health | Measurement | Research Methodology | Hormones | Endocrine System | Physiology | Biology | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Psychological Factors | Signs and Symptoms | Diseases | Contraception | Family Planning
Document Number: 329672

25.

26.

Title: Antiepileptic drugs: are women aware of interactions with oral contraceptives and potential teratogenicity?
Author: Pack AM; Davis AR; Kritzer J; Yoon A; Camus A
Source: Epilepsy and Behavior. 2009 Apr;14(4):640-4.
Abstract: Women with epilepsy (WWE)'s knowledge of the interaction between antiepileptic drugs (AEDs) and oral contraceptives (OCs) and the potential teratogenicity of AEDs has received limited study. We conducted a cross-sectional questionnaire study (English or Spanish) among young WWE (18-44 years) to assess demographic characteristics, current AED use, and knowledge of AED interactions with OCs and teratogenicity. We used the Food and Drug Administration's classification system to categorize each AED's teratogenic potential. Participants (n=148) had a mean age of 32 years (SD 8); 32% spoke Spanish and described themselves as Hispanic. Among women prescribed a cytochrome p450-inducing AED, 65% were unaware of decreased OC efficacy. Forty percent of those prescribed Category D AEDs were unaware of potential teratogenic effects. WWE have limited knowledge of the potential interaction between AEDs and OCs and the teratogenic effects of AEDs. Educational efforts should highlight the reproductive health effects of AEDs in WWE.
Language: English
Keywords:
NEW YORK | RESEARCH REPORT | KAP SURVEYS | CROSS SECTIONAL ANALYSIS | WOMEN | HISPANICS | ORAL CONTRACEPTIVES, SIDE EFFECTS | DRUG INTERACTIONS | CENTRAL NERVOUS SYSTEM EFFECTS | KNOWLEDGE | Developed Countries | United States of America | North America | Americas | Surveys | Sampling Studies | Studies | Research Methodology | Demographic Factors | Population | Ethnic Groups | Cultural Background | Population Characteristics | Contraceptive Safety | Safety | Public Health | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Central Nervous System | Physiology | Biology | Sociocultural Factors
Document Number: 341110

27.

Title: Side effects of oral misoprostol for the prevention of postpartum hemorrhage: results of a community-based randomised controlled trial in rural India.
Author: Patted SS; Goudar SS; Naik VA; Bellad MB; Edlavitch SA; Kodkany BS; Patel A; Chakraborty H; Derman RJ; Geller SE
Source: Journal of Maternal-Fetal and Neonatal Medicine. 2009 Jan;22(1):24-8.
Abstract: OBJECTIVE: To investigate the side effects of 600 microg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH). METHODS: One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe. RESULTS: Women who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns. CONCLUSIONS: Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.
Language: English
Keywords:
INDIA | RESEARCH REPORT | CLINICAL RESEARCH | CASE CONTROL STUDIES | POSTPARTUM WOMEN | WOMEN IN DEVELOPMENT | RURAL POPULATION | COMMUNITY HEALTH SERVICES | SIDE EFFECTS | MISOPROSTOL | BLEEDING | PREVENTION AND CONTROL | PREGNANCY COMPLICATIONS | ORAL CONTRACEPTIVES, SIDE EFFECTS | SIGNS AND SYMPTOMS | Asia, Southern | Asia | Developing Countries | Research Methodology | Studies | Puerperium | Reproduction | Economic Development | Economic Factors | Population Characteristics | Demographic Factors | Population | Primary Health Care | Health Services | Delivery of Health Care | Health | Treatment | Medical Procedures | Medicine | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Diseases | Contraceptive Safety | Safety | Public Health
Document Number: 330717

28.

Title: Are oral contraceptive use and menstrual cycle phase related to anterior cruciate ligament injury risk in female recreational skiers?
Author: Ruedl G; Ploner P; Linortner I; Schranz A; Fink C; Sommersacher R; Pocecco E; Nachbauer W; Burtscher M
Source: Knee Surgery, Sports Traumatology, Arthroscopy. 2009 Mar 31;
Abstract: Oral contraceptive use and menstrual cycle phase are suggested to influence the risk of anterior cruciate ligament (ACL) injuries in female athletes. However, only few data are available for recreational sports. Therefore, female recreational skiers with a non-contact ACL injury and age-matched controls completed a self-reported questionnaire relating to menstrual history, oral contraceptive use and previous knee injuries. Menstrual history data were used to group subjects into either preovulatory or postovulatory phases of menstrual cycle. Our findings suggest that oral contraceptive use did not show any protective effect against ACL injuries nor did self-reported previous knee injuries show any association with ACL injury rate in recreational alpine skiing. Analysis of menstrual history data revealed that recreational skiers in the preovulatory phase were significantly more likely to sustain an ACL injury than were skiers in the postovulatory phase.
Language: English
Keywords:
AUSTRIA | RESEARCH REPORT | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | WOMEN | ATHLETES | SPORTS | LEISURE | ORAL CONTRACEPTIVES | MENSTRUAL CYCLE | ACCIDENTS AND INJURIES | RISK FACTORS | ORAL CONTRACEPTIVES, SIDE EFFECTS | PREVALENCE | Developed Countries | Europe, Central | Europe | Research Methodology | Demographic Factors | Population | Population Characteristics | Social Behavior | Behavior | Contraceptive Methods | Contraception | Family Planning | Menstruation | Reproduction | Health | Contraceptive Safety | Safety | Public Health | Measurement
Document Number: 330925

29.

30.

Title: The Effect of Etoricoxib on the Pharmacokinetics of Oral Contraceptives in Healthy Participants.
Author: Schwartz J; Hunt T; Smith WB; Wong P; Larson P; Crumley T; Mehta A; Gottesdiener K; Agrawal N
Source: Journal of Clinical Pharmacology. 2009 May 14;
Abstract: The pharmacokinetics of oral contraceptive (OC) components, ethinyl estradiol (EE) and norethindrone (NET), were evaluated after coadministration with etoricoxib in 3 double-blind, randomized, 2-period crossover studies of healthy women. There were 16, 39, and 24 participants enrolled in studies 1 (part I, part II), and 2, respectively. Each participant received triphasic OC (EE 35 microg/NET 0.5 mg x 7 days, 0.75 mg x 7 days, 1.0 mg x 7 days) throughout each 28-day period. OC was coadministered with 21 days of etoricoxib daily followed by placebo for 7 days; the alternate period followed the reverse regimen (placebo to etoricoxib). Study 1 (part I) examined concurrent (morning) administration of OC/etoricoxib 120 mg, study 1 (part II) examined staggered (morning/night) administration of OC/etoricoxib 120 mg, and study 2 examined concurrent (morning) administration of OC/etoricoxib 60 mg. Coadministration of OC and etoricoxib 120 mg once daily was associated with a ~50% to 60% increase in EE concentrations, whereas etoricoxib 60 mg once daily was associated with a ~37% increase in EE concentrations. Coadministration of OC and etoricoxib was generally well tolerated. A clinically important change in NET AUC0-24 h was not observed. Adverse events included dyspepsia, diarrhea, headache, nausea, fatigue, loss of appetite, and taste disturbance.
Language: English
Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | DOUBLE-BLIND STUDIES | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS |