| 1. Title: Intrauterine devices: an effective alternative to oral hormonal contraception. Source: Prescrire International. 2009 Jun;18(101):125-30. Abstract: (1) Intrauterine devices (IUDs) are placed in the uterine cavity with the objective of providing long-term contraception, mainly by preventing fertilisation. The best-known IUDs contain copper, but there is also an IUD delivering levonorgestrel, a progestin; (2) How effective are these devices, and what are their adverse effects? To answer these questions, we analysed the literature using the standard Prescrire methodology; (3) T-shaped copper IUDs, with a copper surface area of 380 mm2 on 3 arms, and the levonorgestrel-releasing device, have similar contraceptive efficacy as combined oral contraceptives that are used correctly. In contrast, IUDs are more effective than oral contraception used incorrectly; (4) Among IUD users, there are on average about 6 pregnancies per 1000 woman-years. There is less experience with the levonorgestrel IUD which seems to be at least as effective as copper IUDs; (5) The rare intrauterine pregnancies that occur in women using an IUD generally end in miscarriage. About 25% of these pregnancies end in a live birth if the device is left in place, compared to about 90% if the device is removed; (6) Ectopic pregnancies are rarer in IUD users than in women who do not use contraception. However, about one in 20 pregnancies that occur in women using an IUD is ectopic; (7) The IUD is expelled in about 5% to 10% of cases within 5 years, and expulsion recurs in about 30% of these women; (8) Problems such as difficult insertion, pain, bleeding and syncope are reported in less than 1.5% of cases overall; (9) Uterine perforation during insertion is rare, occurring in 0.6 to 16 cases per 1000 insertions, regardless of the type of IUD. The risk of perforation is higher when the IUD is inserted less than 4 to 6 weeks after delivery or elective abortion; (10) During the first 3 months after insertion, the risk of pelvic infection is slightly higher than in the general population, especially in women with pre-existing asymptomatic Chlamydia trachomatis infection. There are about 6 pelvic infections per 1000 woman-years of IUD use. Routine antibiotic prophylaxis is unnecessary. The interview and physical examination may lead to diagnosis of C. trachomatis infection or other sexually transmitted infections. In these cases, treatment may be needed before IUD insertion. Women must be warned that IUDs do not protect them from sexually transmitted diseases; (11) Menstrual bleeding is often heavier in women with cooper IUDs than in women who do not use IUDs, and may be associated with menstrual pain; (12) The levonorgestrel IUD is associated with a marked reduction in menstrual blood loss and irregular bleeding; amenorrhoea occurs in 35% of women after 2 years of use. The levonorgestrel IUD also has hormonal adverse effects such as headache, acne, breast tension and functional ovarian cysts; (13) IUDs can safely be used in breastfeeding women, immediately after a pregnancy, in cases of diabetes or HIV infection, during nonsteroidal antiinflammatory drug therapy, and after an ectopic pregnancy. The only problems occurring in women who have never had children are pain during insertion and more frequent expulsions; (14) A copper IUD is a first-line contraceptive method for women with a history of deep venous thrombosis, pulmonary embolism, or coronary events; (15) It is better to postpone IUD insertion when the woman has a genital tract infection or unexplained vaginal bleeding; (16) IUD insertion is an effective alternative to "morning-after" hormonal contraception. Language: English Keywords: GLOBAL | LITERATURE REVIEW | IUD | CONTRACEPTIVE MODE OF ACTION | IUD COMPLICATIONS | IUD EXPULSION | INSERTION | IUD SIDE EFFECTS | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | PREGNANCY, ECTOPIC | UTERINE PERFORATION | Contraceptive Methods | Contraception | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Safety | Public Health | Pregnancy Complications | Diseases | Perforations Document Number: 342301 |
| 2. Title: Contraceptive use among postpartum women - 12 states and New York City, 2004-2006. Author: Centers for Disease Control and Prevention (CDC) Source: MMWR. Morbidity and Mortality Weekly Report. 2009 Aug 7;58(30):821-6. Abstract: Postpartum use of highly effective contraceptive methods can prevent unintended pregnancies and ensure adequate birth spacing. Unintended pregnancies and short interpregnancy intervals are associated with adverse maternal and infant outcomes. In 2001, the year for which the most recent data are available, 49% of all pregnancies were unintended, and 21% of women gave birth within 24 months of a previous birth. Two Healthy People 2010 goals are to increase the percentage of intended pregnancies to 70% (objective 9-1) and to reduce the percentage of births occurring within 24 months of a previous birth to 6% (objective 9-2). To estimate the prevalence and types of contraception being used by women 2-9 months postpartum, CDC analyzed data from the 2004-2006 Pregnancy Risk Assessment Monitoring System (PRAMS) from 12 states and New York City. This report summarizes those results, which indicated that 88.0% of postpartum women reported current use of at least one contraceptive method; 61.7% reported using a method defined as highly effective, 20.0% used a method defined as moderately effective, and 6.4% used less effective methods. Rates of using highly effective contraceptive methods postpartum were lowest among Asian/Pacific Islanders (35.3%), women who had wanted to get pregnant sooner (49.9%), women aged >or=35 years (53.0%), and women who had no prenatal care (54.5%). State policy makers and health-care providers can use these results to promote use of highly effective contraception among postpartum women and target interventions for those with particularly low rates of usage, including women with no prenatal care. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | DATA ANALYSIS | POSTPARTUM WOMEN | ETHNIC GROUPS | CDC | CONTRACEPTIVE USAGE | CONTRACEPTIVE METHODS CHOSEN | CONTRACEPTIVE EFFECTIVENESS | PREGNANCY, UNPLANNED | AGE FACTORS | TITLE 19 MEDICAL ASSISTANCE | Developed Countries | North America | Americas | Research Methodology | Puerperium | Reproduction | Cultural Background | Population Characteristics | Demographic Factors | Population | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Contraception | Family Planning | Reproductive Behavior | Fertility | Population Dynamics | Public Assistance | Grants | Financial Activities | Economic Factors Document Number: 342395 |
3.  Title: Expanding access to injectable contraception. Author: Family Health International [FHI] Source: [Unpublished] [2009]. 12 p. Abstract: A number of technological developments can make injections safer for administration, whether by health personnel, trained community workers or the women themselves: sub-cutaneous injections, which have less complications than intra-muscular injections; non-reusable disposable syringes Distribution by community health workers needs special attention to: the possibility that a woman is already pregnant (or seeking an abortion by using an injectable); the screening of women with pre-existing conditions or on medications; the need for counselling for side-effects (in particular: vaginal bleeding irregularities, amenorrhea, weight gain, delay in return to fertility); the safety of injections to the woman and to the health worker; the possible confusion between different injectables --provided by public and private sectors. To complement pre-service and in-service training, a number of job aids are available to support community workers providing injectables: medical eligibility criteria wheel to screen for eligibility; pregnancy checklist; simplified material for the management of side-effects (bleeding, amenorrhea, weight changes, etc). (Excerpt) Language: English Keywords: GLOBAL | TABLES AND CHARTS | INJECTABLES | DEPO-PROVERA | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE PREVALENCE | CONTRACEPTIVE AVAILABILITY | PROGRAM ACCESSIBILITY | COMMUNITY-BASED DISTRIBUTION | CONTRACEPTIVE SAFETY | MATERNAL MORTALITY | CAUSES OF DEATH | Contraceptive Methods | Contraception | Family Planning | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Usage | Program Evaluation | Programs | Organization and Administration | Nonclinical Distribution | Distributional Activities | Program Activities | Safety | Public Health | Health | Mortality | Population Dynamics | Demographic Factors | Population Document Number: 331838 |
| 4. Title: Scientists recommend new design for female condom research. Author: Family Health International [FHI] Source: [Research Triangle Park, North Carolina], FHI, [2009]. [2] p. (Research Briefs on the Female Condom) Abstract: As the result of a USAID-supported workshop organized by the nonprofit organization CONRAD, scientists have proposed a new design for studies testing the effectiveness of innovations in the female condom. For a female condom to gain regulatory approval in the United States, the U.S. Food and Drug Administration (FDA) currently requires that the product be tested in a large -- and often expensive -- phase III contraceptive-effectiveness trial. CONRAD held the workshop specifically so that experts on female condoms and semen biomarkers could explore acceptable alternatives to this type of trial. The experts identified the well-studied biomarker prostate-specific antigen (PSA) as the most promising marker to pursue for this application. The new study design uses PSA to show the presence of semen in the vagina, which should be a more reliable indicator of clinical condom failure than is the incidence of pregnancy or a sexually transmitted infection. A report of the workshop and the details of the study design are published in the journal Contraception. (Excerpt) Language: English Keywords: UNITED STATES OF AMERICA | SUMMARY REPORT | STUDY DESIGN | WORKSHOPS | FEMALE CONDOMS | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTION RESEARCH | CONDOM FAILURE | SEMEN | ANTIGENS | VAGINA | Developed Countries | North America | Americas | Research Methodology | Education | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | Condoms | Seminal Vesicles | Genitalia, Male | Genitalia | Urogenital System | Physiology | Biology | Immunologic Factors | Immunity | Immune System | Genitalia, Female Document Number: 331704 |
5.  Title: Implanon: a review of the literature with recommendations for clinical management. Author: Adams K; Beal MW Source: Journal of Midwifery and Women's Health. 2009 Mar-Apr;54(2):142-9. Abstract: Implanon is a new implantable, progestin-only contraceptive which was approved in the United States in July 2006. Implanon is comprised of a single ethylene vinylacetate copolymer rod that is 4 cm long and 2 mm in diameter. It is inserted subdermally in the groove between the biceps and triceps of the nondominant arm. A literature review was conducted and side effects are discussed. Implanon offers promise as a high-efficacy, long-term contraceptive and can enhance the contraceptive options offered by the women's health care providers. Clinical trial data indicate that the device is both safe and effective. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | LITERATURE REVIEW | CONTRACEPTIVE AGENTS, PROGESTIN | CONTRACEPTION | CONTRACEPTIVE EFFECTIVENESS | MANAGEMENT | Developed Countries | North America | Americas | Contraceptive Agents, Female | Contraceptive Agents | Family Planning | Organization and Administration Document Number: 341634 |
| 6. Peer Reviewed Title: Menstrual blood loss in women using the frameless FibroPlant LNG-IUS. Author: Andrade A; Wildemeersch D Source: Contraception. 2009 Feb;79(2):134-8. Abstract: BACKGROUND: This study was conducted to report on a menstrual blood loss (MBL) study and iron stores in women with and without heavy menstrual bleeding using the frameless FibroPlant levonorgestrel-releasing intrauterine system (LNG-IUS) for contraception. STUDY DESIGN: An open, prospective, noncomparative MBL study, using FibroPlant releasing 14 mcg of LNG/day for contraception. MBL was assessed by the quantitative alkaline hematin (QAH) technique. RESULTS: The MBL study was conducted in 40 heavy and normally menstruating Brazilian women seeking contraception. MBL was reduced from a mean baseline menstrual volume of 29.7 mL to a mean volume of 1.5 mL after 24 months, while ferritin values increased from a mean value of 31.1 ng/mL (at baseline) to a mean level of 72.5 ng/mL (after 24 months of use). Differences were highly significant (p<.0005). There were no significant differences between those who had normal menstrual bleeding and the heavy bleeders. The heavy bleeders had comparable MBL to thenormal bleeders 3 months after insertion, and by 24 months post-insertion, their ferritin levels were comparable to those of the normal bleeders. Amenorrhea occurred in 80% of women out of 40 after 24 months of use. No pregnancies were recorded. CONCLUSION: The LNG-IUS is effective in reducing MBL in normally menstruating women as well as in women with heavy menstrual bleeding. The authors agree with the recommendations by the UK National Institute for Clinical Effectiveness and the new Finnish guidelines for heavy menstrual bleeding that the LNG-IUS should be positioned as first-line treatment prior to endometrial ablation or hysterectomy. Language: English Keywords: BRAZIL | RESEARCH REPORT | CLINICAL RESEARCH | PROSPECTIVE STUDIES | EPIDEMIOLOGIC METHODS | WOMEN IN DEVELOPMENT | MENSTRUATION | SERUM IRON LEVEL | IUD, HORMONE RELEASING | LEVONORGESTREL | MENORRHAGIA | TIME FACTORS | AMENORRHEA | PREVALENCE | CONTRACEPTIVE EFFECTIVENESS | South America, Eastern | South America | Latin America | Americas | Developing Countries | Research Methodology | Studies | Economic Development | Economic Factors | Reproduction | Hemic System | Physiology | Biology | IUD | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Menstruation Disorders | Diseases | Population Dynamics | Demographic Factors | Population | Measurement Document Number: 331016 |
| 7. Title: Emergency contraception: how does it work? Author: Baird DT Source: Reproductive Biomedicine Online. 2009;18 Suppl 1:32-6. Abstract: Emergency (or post-coital) contraception is any substance or device that is used to prevent pregnancy after unprotected intercourse. Currently used hormonal methods of emergency contraception (high-dose combined oral contraceptive pill or levonorgestrel) prevent about 50-80% of pregnancies. Research has demonstrated that these methods inhibit the midcycle surge of LH from the pituitary and, if given at least 2 days before ovulation, ovulation is delayed or prevented. Ovulation still occurs if administration is delayed until ovulation is imminent. Biological data that suggest that the most likely mode of action is by preventing fertilization are supported by the clinical observation that the greater the interval between coitus and administration the greater the chance of pregnancy. There are no data supporting the view that levonorgestrel can impair the development of the embryo or prevent implantation. In contrast, other very effective methods of emergency contraception, such as mifepristone and intrauterine devices, can also inhibit implantation. Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | EMERGENCY CONTRACEPTION | IUD | RU-486 | LEVONORGESTREL | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | Europe, Western | Europe | Contraception | Family Planning | Contraceptive Methods | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents Document Number: 330739 |
| 8. Title: Added benefits and user satisfaction with a low-dose oral contraceptive containing drospirenone : results of three multicentre trials. Author: Bitzer J; Paoletti AM Source: Clinical Drug Investigation. 2009;29(2):73-8. Abstract: The ethinylestradiol 20 mug/drospirenone 3 mg combined oral contraceptive (COC), administered in cycles of 21 days continuous use followed by a 7-day hormone-free interval (21/7) [Yasminelle((R))], has been proven to be an effective and well tolerated contraceptive with an acceptable bleeding pattern and good safety profile. In addition, the ethinylestradiol 20 mug/drospirenone 3 mg 21/7 COC prevents water-retention-related weight gain, and improves physical and emotional well-being, consistent with other drospirenone-containing COCs. In clinical studies, >85% of those who received the ethinylestradiol 20 mug/drospirenone 3 mg 21/7 COC were satisfied or very satisfied with this contraceptive. The positive attributes of the ethinylestradiol 20 mug/drospirenone 3 mg 21/7 COC beyond contraceptive protection may have important implications for improving treatment compliance and reducing treatment discontinuation. Physical well-being stayed the same or improved during use of this COC in 56% and 34% of women, respectively. Emotional well-being stayed the same or improved in 71% and 20% of women, respectively. Language: English Keywords: ITALY | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE EFFECTIVENESS | SATISFACTION | Developed Countries | Europe, Southern | Europe | Studies | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Psychological Factors | Behavior Document Number: 329809 |
| 9. Title: [Contraceptive compliance - why is contraceptive failure still so frequent?] Kontrazeptive Compliance - warum kommt es immer wieder zum Versagen der Author: Bitzer J Source: therapeutische Umschau. Revue therapeutique. 2009 Feb;66(2):137-43. Abstract: Contraceptive compliance is defined as the correct use (according to the method specific prescriptions given by a medical professional and/or in written form as patient information leaflet) of a contraceptive method. Non-compliance describes a mismatch between the real behaviour of a user and the correct or ideal behaviour. There are various indicators that in general contraceptive compliance is far from ideal. Many studies report a rate of unintended pregnancies of 50%, half of them terminating in abortion. The abortion rate remains high even in countries with availability of advanced contraceptive technology. Especially with hormonal contraception and barrier methods the gap between correct and real use is large. Discontinuation rates per year reach up to 50%. Reasons for Non Compliance are (a) Lack of motivation to prevent a pregnancy due to ambivalence regarding the wish for a child as well as sexual and relationship issues (b) Cognitive factors (False information, misconceptions, irrational fears) (c) Difficult or lacking access to contraceptive methods (d) Behavioral errors and mistakes (Forgetting, loosing etc.) and (e) Side effects of the methods used. Three strategies to improve compliance can be distinguished: (a) Improving counselling; (b) Developing contraceptive methods which demand a low level of compliant behaviour by the user; (c) Improving quality of life of users by minimizing the negative side effects and maximizing the non contraceptive health benefits. Language: German Keywords: BRAZIL | RESEARCH REPORT | CONTRACEPTION FAILURE | USER COMPLIANCE | PRESCRIPTIONS | CONTRACEPTIVE METHODS | QUALITY OF LIFE | PREGNANCY, UNPLANNED | CONTRACEPTIVE EFFECTIVENESS | Developing Countries | South America, Eastern | South America | Latin America | Americas | Contraceptive Usage | Contraception | Family Planning | Behavior | Distributional Activities | Program Activities | Programs | Organization and Administration | Social Welfare | Economic Factors | Reproductive Behavior | Fertility | Population Dynamics | Demographic Factors | Population Document Number: 329568 |
| 10. Title: Patterns and trends in adolescents' contraceptive use and discontinuation in developing countries and comparisons with adult women. Author: Blanc AK; Tsui AO; Croft TN; Trevitt JL Source: International Perspectives On Sexual and Reproductive Health. 2009 Jun;35(2):63-71. Abstract: Demographic and Health Survey data from more than 40 countries were used to examine the proportions of 15- to 19-year-old women who are currently married or are unmarried but sexually active; their rates of contraceptive adoption, current use, discontinuation, method switching and contraceptive failure; trends in these indicators; and comparisons with older women. In many countries, the proportion of adolescent women using contraceptives increased substantially over the last two decades. Prevalence among adolescents increased faster than among older women. Greater proportions of adolescents than of older women discontinued using a contraceptive method within a year or experienced contraceptive failure. The authors conclude that expanded demand for contraceptive supplies, services, and information can be expected to challenge the preparedness, capacity, and resources of existing family planning programs and providers. Language: English Keywords: DEVELOPING COUNTRIES | RESEARCH REPORT | DEMOGRAPHIC AND HEALTH SURVEYS | COMPARATIVE STUDIES | ADOLESCENTS, FEMALE | WOMEN | OLDER ADULTS | AGE FACTORS | CONTRACEPTIVE METHOD SWITCHING | CONTRACEPTIVE USAGE | CONTRACEPTIVE EFFECTIVENESS | FAMILY PLANNING PROGRAM EVALUATION | Demographic Surveys | Population Dynamics | Demographic Factors | Population | Studies | Research Methodology | Adolescents | Youth | Population Characteristics | Adults | Contraception | Family Planning | Family Planning Programs Document Number: 342143 |
| 11. Peer Reviewed Title: Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard gel: a randomized, cross-over, pharmacokinetic study. Author: Brache V; Croxatto H; Kumar N; Sitruk-Ware R; Cochon L; Schiappacasse V; Sivin I; Munoz C; Maguire R; Faundes A Source: Contraception. 2009 Feb;79(2):150-4. Abstract: BACKGROUND: The Population Council studied a pre-coital contraceptive microbicide vaginal product containing levonorgestrel (LNG) as active component and Carraguard gel as a vehicle (Carra/LNG gel) for couples who engage in occasional unplanned intercourse. The objective of this study was to evaluate the effect of sexual intercourse after vaginal application of Carra/LNG gel on serum levels of LNG in women and to assess LNG absorption by the male partner. STUDY DESIGN: This was a randomized, cross-over, pharmacokinetic study including an abstinence arm and an arm in which couples engaged in sexual intercourse between 2 and 4 h after gel application. In each study arm, each woman received a single application of Carra/LNG gel (0.75 mg in 4 mL gel) followed by serial blood samples taken at 0, 1, 2, 4, 8, 24 and 48 h after gel application for LNG measurements. In the intercourse arm, LNG was measured in blood samples taken from the male partner before intercourse and at 4, 8 and 24 h after gel application in the female partner. RESULTS: Time concentration curves for serum LNG levels showed a mean C(max) of 7.8+/-5.5 and 8.3+/-5.7 nmol/L, a mean T(max) of 6.2+/-5.9 and 7.5+/-5.7, and comparable area under the curve for the intercourse and abstinence arm, respectively. Pharmacokinetic parameters presented large variability between subjects, but excellent reproducibility within each subject. LNG was undetectable in 10 out of 12 male partners. CONCLUSION: Sexual intercourse does not appear to interfere with vaginal absorption of LNG after application of a Carra/LNG gel. A vaginal pre-coital contraceptive gel is feasible. Language: English Keywords: DOMINICAN REPUBLIC | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN IN DEVELOPMENT | SEXUAL PARTNERS | SEXUAL INTERCOURSE | PHYSIOLOGY | LEVONORGESTREL | VAGINAL GEL | MICROBICIDES | TIME FACTORS | CONTRACEPTIVE EFFECTIVENESS | EMERGENCY CONTRACEPTION | Developing Countries | Caribbean | Americas | Research Methodology | Economic Development | Economic Factors | Sex Behavior | Behavior | Reproduction | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Vaginal Spermicides | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Dynamics | Demographic Factors | Population Document Number: 331015 |
| 12. Peer Reviewed Title: Association between efficacy and body weight or body mass index for two low-dose oral contraceptives. Author: Burkman RT; Fisher AC; Wan GJ; Barnowski CE; LaGuardia KD Source: Contraception. 2009 Jun;79(6):424-7. Abstract: BACKGROUND: This analysis investigated the association of oral contraceptive efficacy with body weight and body mass index (BMI) for hypothesis-generating purposes. STUDY DESIGN: Data were from a randomized, parallel-group trial of 180/215/250 mcg of norgestimate (NGM)/25 mcg of ethinyl estradiol (EE) (given to 1671 women) and 1 mg of norethindrone acetate (NETA)/20 mcg of EE (given to 1139 women). Pregnancies were evaluated across BMI deciles and by BMI and body weight dichotomies. A Pearl index was calculated for each treatment group. The relative risk (RR) of pregnancy was calculated with a Cox proportional hazards model. RESULTS: The Pearl index for women who received NGM/EE was 2.36 [95% confidence interval (CI)=1.33-3.40]; for those who received NETA/EE, the Pearl index was 3.29 (95% CI=1.81-4.77). Consistent, weak positive associations between weight and pregnancy risk were found. Overall, for women with a BMI >or=25 kg/m(2) (compared with women with a BMI <25 kg/m(2)), the RR of pregnancy was 1.84 (95% CI=0.98-3.45); that for women who received NGM/EE was 1.39 (95% CI=0.57-3.40), whereas that for women who received NETA/EE was 2.49 (95% CI=1.01-6.13). For women with a body weight >or=70 kg (compared with women with a body weight <70 kg), the RR was 1.25 (95% CI=0.63-2.46); that for women who received NGM/EE was 1.41 (95% CI=0.56-3.54), whereas that for women who received NETA/EE was 1.12 (95% CI=0.40-3.12). CONCLUSION: Women in the higher body weight or BMI category showed a small increase in the risk of pregnancy with these oral contraceptives, but this increase was not statistically significant overall or for either formulation studied. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | COMPARATIVE STUDIES | WOMEN | CONTRACEPTIVE EFFECTIVENESS | BODY WEIGHT | NORGESTIMATE | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | NORETHINDRONE ACETATE | ADMINISTRATION AND DOSAGE | Developed Countries | North America | Americas | Research Methodology | Studies | Demographic Factors | Population | Contraception | Family Planning | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Oral Contraceptives | Contraceptive Methods | Norethindrone | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341104 |
| 13. Peer Reviewed Title: Route of administration of contraceptives containing desogestrel/etonorgestrel and insulin sensitivity: a prospective randomized study. Author: Cagnacci A; Ferrari S; Tirelli A; Zanin R; Volpe A Source: Contraception. 2009 Jul;80(1):34-9. Abstract: BACKGROUND: The study was conducted to investigate whether hormonal contraceptives administered via the oral and vaginal route exert a similar effect on insulin sensitivity (SI). STUDY DESIGN: This is a prospective, randomized study performed in the University Hospital. Subjects were healthy lean young women, needing a hormonal contraceptive, randomly allocated to receive for 6 months (a) an oral contraceptive (OC) containing 30 mcg ethinylestradiol (EE)/150 mcg desogestrel (DSG) (high-estrogen group; n=12), (b) an OC containing 20 mcg EE/150 mcg DSG (low-estrogen group; n=12) and (c) a vaginal ring contraceptive releasing, per day, 15 mcg EE/120 mcg etonorgestrel, the active DSG metabolite (n=12). SI and glucose utilization independent of insulin (Sg) were evaluated by the minimal model method. Modifications of total, high-density lipoprotein (HDL) and low-density lipoprotein cholesterol and triglycerides were also evaluated. RESULTS: Sg did not vary with any treatment. SI decreased during OCs (5.74+/-0.49 vs. 3.86+/-0.44; p=.0005), independently of the high/low-estrogen dose. SI did not decrease during vaginal ring use (4.64+/-1.03 vs. 5.25+/-1.36; p=.57; p=.019 vs. oral). Total cholesterol and HDL cholesterol increased (p=.02) during OCs, independently of the dose. Triglycerides increased during both oral (p=.01) and vaginal (p=.032) contraceptive use. CONCLUSIONS: The present data indicate that in contrast to OC use, vaginal contraception with the ring does not deteriorate SI. The vaginal ring may represent an appropriate choice for long-term contraception in women at risk for developing diabetes mellitus or metabolic syndrome. Language: English Keywords: ITALY | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | VAGINAL RING | CONTRACEPTION | ADMINISTRATION AND DOSAGE | DESOGESTREL | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | Europe, Southern | Europe | Studies | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents Document Number: 341584 |
| 14. Title: Emergency contraception: have we come full circle? [editorial] Author: Coeytaux F; Wells ES; Westley E Source: Contraception. 2009 Jul;80(1):1-3. Abstract: Two decades ago, Dr. Felicia Stewart, then serving as Medical Director of the Planned Parenthood affiliate in Sacramento, CA, began her campaign to let out of the closet "America's best-kept secret" - emergency contraception (EC). The method had been suppressed because many providers thought the method was "not effective enough" or would lead women to use it "too much" (in place of using other more effective methods). Advocates disagreed, believing that EC could help some women prevent pregnancy, that women could learn to use the method appropriately, and that women had the right to this important option. When Dr. Stewart and other women's health advocates pushed to move EC "from secret to shelf," they had women's needs in mind - in particular the need for a method that, unlike others, could be used after sex and one that was safe enough to provide without the barrier of a medical interface. The success of this 20-year effort is evident in the many dedicated EC products now available worldwide, the increase in women's awareness and use of EC, and, in the United States, the full-on direct to consumer marketing of EC by a pharmaceutical company, not to mention the popularity of the method among women. Today, in the midst of this forward trajectory of increased access and awareness, we have encountered a curve ball that has us circling back to where we started. Recent analyses suggesting that EC is not as effective in reducing unwanted pregnancy rates at a population level as we once hoped seem to have put the brakes on funding and have revived the original arguments that EC is "not effective enough" to be promoted as an option and that women are "abusing" it, using it repeatedly instead of using other more effective methods. Some in the field have also again voiced concerns that by providing it directly to women we are missing opportunities to provide women with a full range of reproductive health services. Our response to this recent round of questioning is that EC still fills a unique and important role in the mix of available contraceptive methods, that it is effective enough to be promoted as a contraceptive option and that women's use of the method does not constitute a problem (in terms of lower effectiveness) but rather contributes in a positive way to every woman's significant challenge of how to avoid unplanned pregnancies over her lengthy fertile years. (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | CRITIQUE | WOMEN | EMERGENCY CONTRACEPTION | AWARENESS | FERTILITY CONTROL, POSTCOITAL | CONTRACEPTIVE EFFECTIVENESS | INFORMED CHOICE | PROGRAM ACCESSIBILITY | Developed Countries | North America | Americas | Demographic Factors | Population | Contraception | Family Planning | Knowledge | Sociocultural Factors | Contraceptive Usage | Program Evaluation | Programs | Organization and Administration Document Number: 341588 |
| 15. Peer Reviewed Title: Satisfaction and compliance in hormonal contraception: the result of a multicentre clinical study on women's experience with the ethinylestradiol/norelgestromin contraceptive patch in Italy. Author: Crosignani PG; Nappi C; Ronsini S; Bruni V; Marelli S; Sonnino D; Study Group IE Source: BMC Women's Health. 2009 Jun 30;9(1):18. Abstract: ABSTRACT: BACKGROUND: For many women finding the right contraceptive method can be challenging and consistent and correct use over a lifetime is difficult. Even remembering to take a birth control pill every day can be a challenge. The primary objective of this study was to evaluate women's experience with a weekly ethinylestradiol/norelgestromin contraceptive patch (EE/NGMN patch), given new technologies recently developed in hormonal contraception to increase women's options in avoiding daily dosing. METHODS: In 24 Italian sites, 207 women received the EE/NGMN patch for up to 6 cycles. At study end, overall satisfaction and preference, as well as compliance, efficacy and safety, were evaluated. RESULTS: 175 women (84.5%) completed the study. The overall satisfaction rate was 88%; convenience and once-a-week frequency of the patch were especially appreciated. At baseline, 82 women (39.4%) were using a contraceptive method, mainly oral contraceptives and barrier methods, but only 45.1% were very satisfied/satisfied; after 6 months with the patch, 86.3% of this subset was very satisfied/satisfied. Considering the method used in the 3 months before the study entry, 78.1% strongly preferred/preferred the patch, for convenience (53.9%), ease of use/simplicity (28.9%), fewer (9.2%) and less severe (2.6%) side effects. Compliance was very high: 1034/1110 cycles (93.2%) were completed with perfect compliance and the mean subject's compliance score was 90%. One on-therapy pregnancy occurred. The patch was safe and well tolerated: adverse events frequency was low, with predominantly single reports of each event. Most of them started and subsided during cycle 1. CONCLUSIONS: This study demonstrated that the EE/NGMN patch is associated with high satisfaction levels and excellent compliance. At study end, the majority of women indicated that they would continue using the patch. Language: English Keywords: ITALY | RESEARCH REPORT | FAMILY PLANNING ACCEPTORS | CONTRACEPTION RESEARCH | CONTRACEPTIVE METHODS | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, PROGESTIN | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | SATISFACTION | USER COMPLIANCE | Developed Countries | Europe, Southern | Europe | Family Planning Programs | Family Planning | Contraception | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Safety | Public Health | Health | Psychological Factors | Behavior Document Number: 341863 |
| 16. Peer Reviewed Title: Oral contraceptive effectiveness according to body mass index, weight, age, and other factors. Author: Dinger JC; Cronin M; Mohner S; Schellschmidt I; Minh TD; Westhoff C Source: American Journal of Obstetrics and Gynecology. 2009 May 28; Abstract: OBJECTIVE: The purpose of this study was to assess the use-effectiveness of oral contraceptives (OCs) in Europe according to body mass index (BMI), weight, age, and other factors. STUDY DESIGN: In a planned secondary analysis, we used data from the European Active Surveillance Study on Oral Contraceptives, which was a prospective active cohort surveillance study of 59,510 OC users, to assess the effectiveness of OCs overall and by BMI, weight, age, duration of use, ethinylestradiol dose, regimen type, starting/switching status, and parity. Self-reported unplanned pregnancies during OC use were confirmed by interview. RESULTS: An analysis of OC effectiveness (112,659 women-years of exposure and 545 unplanned pregnancies) found little variation in effectiveness by BMI/weight. Failure rates decreased after 30 years of age and with an increasing duration of use. CONCLUSION: OC users in Europe reported high contraceptive effectiveness with "typical use." Failure rates decreased with age and duration ofuse. BMI and weight had little, if any, influence on effectiveness. Language: English Keywords: EUROPE | RESEARCH REPORT | COHORT ANALYSIS | WOMEN | CONTRACEPTIVE USAGE | CONTRACEPTIVE EFFECTIVENESS | BODY WEIGHT | AGE FACTORS | Developed Countries | Research Methodology | Demographic Factors | Population | Contraception | Family Planning | Physiology | Biology | Population Characteristics Document Number: 341572 |
| 17. Peer Reviewed Title: Profile of the progesterone derivative chlormadinone acetate - pharmocodynamic properties and therapeutic applications. Author: Druckmann R Source: Contraception. 2009 Apr;79(4):272-81. Abstract: Chlormadinone acetate (CMA) is a derivative of progesterone (17alpha-acetoxy-6-chloro-4,6-pregnadiene-3,20-dione), first synthesized in 1961 and is used as an orally effective progestogen in hormone replacement therapy (HRT), and in combination with ethinyl estradiol (EE) in contraception since 1999. Chlormadinone acetate has a strong progestogenic effect - about one-third higher than that of progesterone - and may vary depending on the previous effect of an estrogen, i.e., estrogens may promote the formation of progesterone receptors and proliferation of the endometrium. Like progesterone, it is anti-estrogenic and has no partial androgenic effect (at the doses used for contraception and HRT). In contrast to progesterone, it has a slight glucocorticoid effect, a pronounced anti-androgenic effect and no anti-mineralocorticoid effect. No pregnancy-maintaining effect of CMA has been demonstrated in humans. The anti-androgenic effect of CMA is presumed to be the result of both its binding to androgen receptors - competitively inhibiting the effect of endogenous testosterone and dihydrotestosterone - and the competitive inhibition of 5alpha-reductase. In this respect, dosing of CMA is crucial; agonistic effects are observed when doses are increased from those optimal for an antagonistic effect. Chlormadinone acetate has a strong anti-gonadotropic effect, through negative feedback on gonadotropin secretion, and has been used for more than 20 years alone for contraception in arterial risk patients. The clinical and metabolic tolerability of CMA has been demonstrated in numerous clinical studies with duration of treatment of up to 2.5 years. The more recent application of CMA as an oral contraceptive in combination with EE (Neo Eunomin, Belara) has proven highly successful, with studies reporting excellent contraceptive efficacy, high tolerability and adherence due to a good side effect profile and positive effects on preexisting dysmenorrhea, skin and hair conditions. Language: English Keywords: FRANCE | RESEARCH REPORT | ORAL CONTRACEPTIVES | CONTRACEPTIVE AGENTS, PROGESTIN | PROGESTERONE | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | Europe, Western | Europe | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology Document Number: 341633 |
| 18. Peer Reviewed Title: Multicenter Contraceptive Efficacy Trial of Injectable Testosterone Undecanoate in Chinese Men. Author: Gu Y; Liang X; Wu W; Liu M; Song S; Cheng L; Bo L; Xiong C; Wang X; Liu X; Peng L; Yao K Source: Journal of Clinical Endocrinology and Metabolism. 2009 Jun;94(6):1910-1915. Abstract: Context: Hormonal male contraceptive regimens effectively and reversibly suppress sperm production but there are few large-scale efficacy studies. Objective: The safety, contraceptive efficacy, reversibility and feasibility of injectable testosterone undecanoate (TU) in tea seed oil as a hormonal male contraceptive was assessed. Design: This was a mutilcenter, phase III, contraceptive efficacy clinical trial. Participants: 1045 healthy fertile Chinese men were recruited throughout China into the study. Intervention(s): Monthly injections of 500 mg TU, administered for 30 months. A definition of severe oligozoospermia (Language: English Keywords: CHINA | RESEARCH REPORT | CLINICAL TRIALS | MEN | INJECTABLES | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE AGENTS, MALE | CONTRACEPTIVE SAFETY | REVERSIBLE STERILIZATION | ADMINISTRATION AND DOSAGE | SPERMATOGENESIS BLOCKING AGENTS | TESTIS | SEMEN | HORMONES | TIME FACTORS | Asia, Eastern | Asia | Developing Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents | Safety | Public Health | Health | Sterilization, Sexual | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Genitalia, Male | Genitalia | Urogenital System | Physiology | Biology | Seminal Vesicles | Endocrine System | Population Dynamics Document Number: 330735 |
| 19. Peer Reviewed Title: Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen. Author: Hernadi L; Marr J; Trummer D; De Leo V; Petraglia F Source: Contraception. 2009 Jul;80(1):18-24. Abstract: OBJECTIVE: The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen). STUDY DESIGN: In this open-label uncontrolled study conducted in 50 European centers, healthy females aged 18-35 years with a body mass index of less than 30 kg/m(2) received drsp 3 mg/EE 20 mcg 24/4 over 13 cycles. The primary efficacy variable was the number of unintended pregnancies. RESULTS: Five pregnancies occurred among 1101 women over 13,248 treatment cycles, resulting in a Pearl Index (PI) of 0.49 with an upper two-sided 95% CI limit of 1.14. Of these pregnancies, three were attributed to noncompliance with tablet use resulting in an adjusted PI for 'perfect use' of 0.22 (upper limit of two-sided 95% CI: 0.80) based on 11,755 cycles. CONCLUSION: Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women. Language: English Keywords: EUROPE | RESEARCH REPORT | CLINICAL TRIALS | PEARL'S FORMULA | WOMEN | CONTRACEPTIVE EFFECTIVENESS | ORAL CONTRACEPTIVES, LOW-DOSE | ORAL CONTRACEPTIVES, COMBINED | ETHINYL ESTRADIOL | CONTRACEPTIVE SAFETY | Developed Countries | Clinical Research | Research Methodology | Contraceptive Use-Effectiveness | Contraception | Family Planning | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Safety | Public Health | Health Document Number: 341586 |
| 20. 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 |
| 21. Peer Reviewed Title: The risk of unintended pregnancies in users of the contraceptive patch compared to users of oral contraceptives in the UK General Practice Research Database. Author: Jick SS; Hagberg KW; Kaye JA; Jick H Source: Contraception. 2009 Aug;80(2):142-51. Abstract: BACKGROUND: The transdermal contraceptive patch EVRA has been marketed since 2002 as an alternative to oral contraceptives (OCs), but large follow-up studies of effectiveness are lacking. STUDY DESIGN: We used a cohort plus a nested case-control study to estimate rates and hazard ratios of unintended pregnancy among users of different hormonal contraceptives (HC) and to evaluate the effects of various potential predictors on unintended pregnancy. RESULTS: Rates of unintended pregnancy were all low (overall rate 0.17 per 100 women-years), though they were slightly higher in users of progestogen-only OCs and EVRA compared to users of second-generation OCs. The hazard ratios for unintended pregnancy were also higher for users of progestogen-only OCs and the patch compared to users of second-generation OCs, although these estimates may be confounded by compliance. Rates of unintended pregnancy were inversely associated with age and duration of HC use as well as with other predictors of pregnancy but not body mass index or use of antibiotics. CONCLUSION: The rates of unintended pregnancy were low for all study HCs, and while the data on unintended pregnancy in EVRA users compared to OC users are sufficient to rule out major differences in the rate of unintended pregnancy, they are not sufficient to rule out modest ones. Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | COHORT ANALYSIS | CONTROL GROUPS | WOMEN | ORAL CONTRACEPTIVES | CONTRACEPTIVE METHODS | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTION FAILURE | PREGNANCY, UNPLANNED | INFORMATION RETRIEVAL SYSTEMS | QUESTIONNAIRES | Developed Countries | Europe, Western | Europe | Research Methodology | Demographic Factors | Population | Contraception | Family Planning | Contraceptive Usage | Reproductive Behavior | Fertility | Population Dynamics | Data Storage and Retrieval | Information Processing | Information Document Number: 342306 |
| 22. Peer Reviewed Title: Subcutaneous DMPA vs. intramuscular DMPA: a 2-year randomized study of contraceptive efficacy and bone mineral density. Author: Kaunitz AM; Darney PD; Ross D; Wolter KD; Speroff L Source: Contraception. 2009 Jul;80(1):7-17. Abstract: BACKGROUND: A formulation of depot medroxyprogesterone acetate (DMPA) has been developed that allows subcutaneous injection (104 mg/0.65 mL; DMPA-SC) and achieves highly effective contraception with a similar tolerability profile to intramuscular DMPA (150 mg/mL; DMPA-IM). STUDY DESIGN: This randomized, evaluator-blinded study was designed to compare efficacy, safety, and user satisfaction in women receiving DMPA-SC (n=266) or DMPA-IM (n=268) for 2 years with an option to continue for a third year. The primary objectives were to evaluate bone mineral density (BMD) changes and contraceptive efficacy after 2 years. RESULTS: A total of 225 women completed the first 2 years of this study (DMPA-SC, n=116; DMPA-IM, n=109). After 2 years of DMPA use, BMD loss was marginally smaller in the DMPA-SC group than in the DMPA-IM group at both the total hip (-3.3% and -3.6%, respectively) and lumbar spine (-4.3% and -5.0%, respectively). In those women who received DMPA during the third year, there were no statistically significant differences in BMD loss between DMPA-SC and DMPA-IM groups at the end of Year 3. Recovery of BMD was observed in the small subpopulation of women who had discontinued DMPA-SC or DMPA-IM after the second year. The 2-year treatment-failure cumulative pregnancy rate was 0% in the DMPA-SC group and 0.8% (95% confidence interval, 0.00-2.37%) in the DMPA-IM group (life-table method). Adverse events were similar in the two groups except that injection site reactions were more common in the DMPA-SC group. CONCLUSION: DMPA-SC is an effective and well-tolerated contraceptive option, providing comparable efficacy and BMD safety to DMPA-IM. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | SKELETAL EFFECTS | MEDROXYPROGESTERONE ACETATE | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | SATISFACTION | Developed Countries | North America | Americas | Demographic Factors | Population | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Safety | Public Health | Psychological Factors | Behavior Document Number: 341587 |
| 23. Peer Reviewed Title: The cost-effectiveness of a long-acting reversible contraceptive (Implanon) relative to oral contraception in a community setting. Author: Lipetz C; Phillips CJ; Fleming CF Source: Contraception. 2009 Apr;79(4):304-9. Abstract: BACKGROUND: Within the setting of a UK community sexual health service, the cost-effectiveness of Implanon and oral contraception provision over a 36-month period was compared. STUDY DESIGN: A case-controlled retrospective cost-effectiveness study was done on a cohort of 493 Implanon users and 493 oral contraceptive users. The actual cost of provision of both methods was calculated. Cost-effectiveness was calculated based on provision of method and pregnancy costs of each cohort. RESULTS: Implanon provision is more cost-effective than oral contraception at all time points. After 12 months of use, Implanon is half the cost of oral contraception. Oral contraception reached similar annual cost to Implanon at 36 months of use. CONCLUSIONS: Long-acting reversible contraception is perceived to be expensive. It is reassuring to contraception providers that Implanon is, in fact, highly cost-effective when compared to oral contraception with typical use. Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | COST EFFECTIVENESS | ORAL CONTRACEPTIVES | CONTRACEPTIVE IMPLANTS | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | Europe, Western | Europe | Evaluation Indexes | Quantitative Evaluation | Evaluation | Contraceptive Methods | Contraception | Family Planning Document Number: 330557 |
| 24. Peer Reviewed Title: Theory-based strategies for improving contraceptive use: a systematic review. Author: Lopez LM; Tolley EE; Grimes DA; Chen-Mok M Source: Contraception. 2009 Jun;79(6):411-7. Abstract: BACKGROUND: Theories and models help explain how behavior change occurs. We systematically reviewed randomized controlled trials that examined theory-based interventions for improving contraceptive use. STUDY DESIGN: We searched electronic databases for eligible trials. Primary outcomes included pregnancy and contraceptive use. We calculated the odds ratio for dichotomous outcomes and the mean difference for continuous data. RESULTS: Of 14 included trials, 10 showed positive results for a theory-based group: 2 of 10 studies with pregnancy or birth data, 4 of 9 addressing contraceptive use (for contraception) and 5 of 9 with condom use (to prevent HIV/sexually transmitted infections). An experimental group had favorable results for six of seven trials based on Social Cognitive Theory, two based on other social cognition models and two using motivational interviewing. Most interventions focused on adolescents and involved multiple sessions. CONCLUSIONS: Effects were not consistent across outcomes and comparisons. The field could benefit from thorough use of single theories and better reporting on intervention implementation. Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | THEORETICAL STUDIES | CASE CONTROL STUDIES | KAP SURVEYS | THEORETICAL MODELS | WOMEN | ADOLESCENTS | CONTRACEPTIVE USAGE | CONDOM USE | CONTRACEPTIVE EFFECTIVENESS | SEXUALLY TRANSMITTED DISEASE PREVENTION | MOTIVATION | TIME FACTORS | PROGRAM DESIGN | Developed Countries | North America | Americas | Studies | Research Methodology | Surveys | Sampling Studies | Demographic Factors | Population | Youth | Age Factors | Population Characteristics | Contraception | Family Planning | Risk Reduction Behavior | Behavior | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Diseases | Psychological Factors | Population Dynamics | Programs | Organization and Administration Document Number: 341105 |
| 25. Peer Reviewed Title: Critical next steps for female condom research - report from a workshop. Author: Mauck CK; Weaver MA; Schwartz JL; Walsh T; Joanis C Source: Contraception. 2009 May;79(5):339-44. Abstract: In addition to a standard slippage and breakage study, the United States Food and Drug Administration (USFDA) currently requires a contraceptive effectiveness trial to be carried out as part of the pathway to regulatory approval for new female condoms. In an attempt to explore acceptable alternatives to expensive and resource-consuming Phase 3 contraceptive effectiveness trials, the United States Agency for International Development (USAID) recently requested that CONRAD organize a 1-day meeting of investigators in the female condom and semen biomarker fields. The charge to the group was to devise a study design that would validate a biomarker against a biological end point, such as pregnancy or a sexually transmitted infection (STI), so that the validated marker could be used to augment a slippage and breakage study for approval of new female condoms, eliminating the need for the currently required contraceptive effectiveness trial. The meeting was entitled "Critical Next Steps for Female Condom Research - A Meeting/Workshop" and was convened by CONRAD in Arlington, VA, on July 8, 2008, with USAID support. Afterward, a working group of clinical researchers continued deliberations via teleconference and wrote the following report. After exploring the pros and cons of several biological markers, prostate-specific antigen (PSA) was identified as the most promising one to pursue for this application because of the extensive, previous work involving that marker. (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | DEVELOPING COUNTRIES | RESEARCH PROPOSAL | METHODOLOGICAL STUDIES | CLINICAL RESEARCH | EVALUATION RESEARCH | CLINICAL TRIALS | WOMEN | WOMEN IN DEVELOPMENT | FEMALE CONDOMS | WORKSHOPS | CONTRACEPTIVE EFFECTIVENESS | CANCER | ANTIGENS | CONTRACEPTIVE SAFETY | Developed Countries | North America | Americas | Studies | Research Methodology | Evaluation Methodology | Evaluation | Demographic Factors | Population | Economic Development | Economic Factors | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | Education | Neoplasms | Diseases | Immunologic Factors | Immunity | Immune System | Physiology | Biology | Safety | Public Health | Health Document Number: 330937 |
| 26. Title: Knowledge of emergency contraception amongst tertiary students in far North Queensland. Author: Mohoric-Stare D; DE Costa C Source: Australian and New Zealand Journal of Obstetrics and Gynaecology. 2009 Jun;49(3):307-11. Abstract: BACKGROUND: Emergency contraception (EC) has been available in Australia without prescription since 2003. However, there has been little research into the extent of knowledge of the actions, effectiveness and availability of EC among the general population. AIMS: To determine the extent of knowledge of EC among tertiary students in Far North Queensland, and their ability to access EC in the region. METHODS: A questionnaire was distributed to tertiary students in Cairns asking about their knowledge of EC, its effectiveness and its availability over-the-counter in pharmacies, as well as their willingness to access EC themselves if indicated, in settings in which they may be known, and in those where they would be unknown. RESULTS: Of 500 questionnaires 460 were returned; 29% of participants had used EC in the past. Only 20% understood the correct timeframe in which EC can be used; 40% were not aware of its availability over-the-counter in pharmacies, and more than 20% felt unable to purchase EC in a pharmacy where they could be recognised. Only 44% of participants were aware of the cost of EC. CONCLUSION: A significant lack of information regarding the availability, methods of action and limitations of EC was noted in this well-educated population. There was also a high proportion of participants who felt unable to access EC in a pharmacy where they might be known, a factor limiting accessibility of the method in small town and community settings. Language: English Keywords: AUSTRALIA | RESEARCH REPORT | STUDENTS | EMERGENCY CONTRACEPTION | KNOWLEDGE | QUESTIONNAIRES | CONTRACEPTIVE AVAILABILITY | CONTRACEPTIVE EFFECTIVENESS | AWARENESS | Oceania | Developed Countries | Education | Contraception | Family Planning | Sociocultural Factors Document Number: 341798 |
| 27. Title: Comparative performance of a combined injectable contraceptive (50 mg norethisterone enanthate plus 5mg estradiol valerate) and a combined oral contraceptive (0.15 mg levonorgestrel plus 0.03 mg ethinyl estradiol) in adolescents. Author: Molina RC; Sandoval JZ; Montero AV; Oyarzun PG; Molina TG; Gonzalez EA Source: Journal of Pediatric and Adolescent Gynecology. 2009 Feb;22(1):25-31. Abstract: STUDY OBJECTIVE: To compare in a regular non-clinical trial experience the efficacy, acceptability, and continuation rates of an injectable contraceptive containing 50 mg norethisterone enanthate plus 5mg estradiol valerate (IC) and an oral contraceptive containing 0.15 mg levonorgestrel plus 0.03 mg ethinyl estradiol (OC), among adolescent users. DESIGN: A total of 251 adolescents ages 14-19 were followed during 12 months. The IC group (124 subjects) was studied for 1044 cycles and the OC group (127 subjects) was studied for 1368 cycles. The users were not assigned in a random selection. Information was collected from clinical records. Groups were compared using Pearson chi-square, odds ratio (95% confidence interval), t-test, and proportion difference test. RESULTS: The IC group had significant differences in baseline social risk, confidence, psychiatric problems, consumption of alcohol, and number of sexual partners. At 12 months, the IC group showed significant decrease in weight and increase in hypermenorrhea. In the OC group, dysmenorrhea decreased, and hypomenorrhea and regular cycles were significantly more frequent. One pregnancy occurred in the OC group (Pearl Index: 0.88). Final continuation rates at 12 months were 41.9% and 37.8% for IC and OC, respectively. CONCLUSIONS: The monthly injectable is a recommended contraceptive option for adolescents, especially for those facing psychosocial risk factors. Language: English Keywords: CHILE | RESEARCH REPORT | CLINICAL RESEARCH | COMPARATIVE STUDIES | ADOLESCENTS, FEMALE | INJECTABLES | NORETHINDRONE ENANTHATE | ORAL CONTRACEPTIVES, COMBINED | LEVONORGESTREL | ETHINYL ESTRADIOL | ADMINISTRATION AND DOSAGE | TIME FACTORS | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | Developing Countries | South America, Southern | South America | Latin America | Americas | Research Methodology | Studies | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Norethindrone | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Oral Contraceptives | Contraceptive Agents, Estrogen | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Dynamics | Safety | Public Health Document Number: 330349 |
| 28. Peer Reviewed Title: The effect of access to emergency contraceptive pills on women's use of highly effective contraceptives: results from a French national cohort study. Author: Moreau C; Trussell J; Michelot F; Bajos N Source: American Journal of Public Health. 2009 Mar;99(3):441-2. Abstract: We examined changes in contraceptive behaviors after emergency contraception (EC) pill use. A nationally representative cohort of 2863 French women was studied to identify 272 instances of EC pill use. In 71% of the cases, we found no changes in contraceptive practices from the time of EC pill use to 6 months later: 41% of women continued use of highly effective methods and 30% continued less effective methods. Only 8.4% switched from highly effective to less effective methods. Language: English Keywords: FRANCE | RESEARCH REPORT | CROSS SECTIONAL ANALYSIS | WOMEN | EMERGENCY CONTRACEPTION | CONTRACEPTIVE EFFECTIVENESS | PROGRAM ACCESSIBILITY | Europe, Western | Europe | Developed Countries | Research Methodology | Demographic Factors | Population | Contraception | Family Planning | Program Evaluation | Programs | Organization and Administration Document Number: 330487 |
| 29. Peer Reviewed Title: Highly effective contraception and acquisition of HIV and other sexually transmitted infections. Author: Morrison CS; Turner AN; Jones LB Source: Best Practice and Research: Clinical Obstetrics and Gynaecology. 2009 Apr;23(2):263-284. Abstract: A key question for clinicians is whether an aetiological association exists between highly effective contraceptive methods and women's risk of acquiring sexually transmitted infections (STIs), including human immunodeficiency virus (HIV). The authors searched the peer-reviewed literature for prospective studies published from January 1966 to August 2008 that assessed contraception and STI/HIV risk. The focus was on combined oral contraceptives (OCs), depot-medroxyprogesterone acetate (DMPA), the T380a copper intra-uterine device (IUD) and the risk of infection with HIV, Chlamydia trachomatis and Neisseria gonorrhoeae. Current data suggest that neither OCs nor DMPA increase HIV risk among women in the general population. Data are equivocal for women in high-risk groups (e.g. sex workers). Current data suggest an increased risk of chlamydial infection associated with OC use, with weaker evidence supporting a harmful effect of DMPA. Reports of OCs and gonococcal infection are inconsistent, and DMPA does not appear to be associated with gonorrhoea acquisition. Data suggest no increased STI/HIV risk among copper IUD users. Prospective data on highly effective contraceptive methods and women's STI/HIV risk are limited, and many studies have important methodological weaknesses. Additional information about the STI/HIV risks associated with these highly effective contraceptive methods is needed. Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | WOMEN | CONTRACEPTIVE EFFECTIVENESS | HIV TRANSMISSION | SEXUALLY TRANSMITTED DISEASES | DEPO-PROVERA | IUD | CHLAMYDIA | GONORRHEA | ORAL CONTRACEPTIVES | CONTRACEPTIVE SAFETY | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Contraception | Family Planning | HIV Infections | Viral Diseases | Diseases | Reproductive Tract Infections | Infections | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Methods | Safety | Public Health | Health Document Number: 341508 |
| 30. Peer Reviewed Title: Status of contraceptive vaccines. Author: Naz RK Source: American Journal of Reproductive Immunology. 2009 Jan;61(1):11-8. Abstract: PROBLEM: This is a review of anti-sperm contraceptive vaccines (CV), and synthesis of human scFv antibodies that can be used as immunocontraceptives. METHOD OF STUDY: Various methods of proteomics and genomics, peptide synthesis, phage display technology, and antibody engineering were used to obtain multi-epitope vaccines and human scFv antibodies from immunoinfertile and vasectomized men. The present review primarily focuses on the effect of multi-epitope vaccines and Izumo on fertility, and synthesis and characterization of sperm specific human scFv antibodies. RESULTS: The immunization with Izumo peptides causes a contraceptive effect in female mice. The efficacy is enhanced by combination vaccination, including peptides based on other sperm antigens. Using phage display technology, we were able to synthesize at least four novel scFv antibodies with unique complementarity determining regions (CDRs) that reacted with specific fertility-related sperm antigens. These antibodies inhibited human sperm function in vitro, and their immunocontraceptive effect in vivo by these antibodies is currently being investigated. CONCLUSION: The multi-epitope vaccines may provide an efficacious and viable approach to contraception. The human scFv antibodies, if they block fertility in vivo, may provide unique and novel immunocontraceptives, the first of its kind for human use. The multi-epitope CV and preformed engineered antibodies of defined specificity may obliterate the concern related to inter-individual variability of the immune response. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | GENETIC TECHNIQUES | WOMEN | LABORATORY ANIMALS | CONTRACEPTIVE VACCINES | ANTIGENS | SPERMICIDAL CONTRACEPTIVE AGENTS | ANTIBODIES | GENETICS | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | North America | Americas | Research Methodology | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Demographic Factors | Population | Contraception, Immunological | Contraception | Family Planning | Immunologic Factors | Immunity | Immune System | Physiology | Biology | Contraceptive Agents Document Number: 330063 |
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