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Reviews In Obstetrics and Gynecology. 2010 Spring; 3(2):55-65.Migraine affects as many as 37% of reproductive-age women in the United States. Hormonal contraception is the most frequently used form of birth control during the reproductive years, and given the significant proportion of reproductive-age women affected by migraine, there are several clinical considerations that arise when considering hormonal contraceptives in this population. In this review, key differences among headache, migraine, and migraine with aura, as well as strict diagnostic criteria, are described. The recommendations of the World Health Organization and the American College of Obstetricians and Gynecologists regarding hormonal contraception initiation and continuation in women with these diagnoses are emphasized. Finally, information about the effect of hormonal fluctuations on headache is provided with recommendations regarding contraception counseling in patients who experience headache while taking hormonal contraception.
Human Reproduction Update. 2003 Jan-Feb; 9(1):49-59.Progestogen-only implantable contraceptives are used by increasing numbers of women worldwide. This review outlines the evidence accumulated on these methods to date. Reviews of toxicological evaluations, clinical trials, endocrinological, epidemiological and social science studies, as well as operations research and economic evaluation were undertaken in preparation for an Expert Consultation convened by the World Health Organization in 2001. At the meeting, these reviews were further evaluated and the research results summarized in this consensus paper. A large body of evidence demonstrates the high contraceptive effectiveness and safety of the 5-year levonorgestrel-releasing implants Norplant and Jadelle. Information on the 3-year etonogestrel-releasing implant Implanon is more limited, but suggests that this implant has a high contraceptive effectiveness and a satisfactory safety pro®le. Information available on levonorgestrel-releasing implants manufactured and approved in China suggests that their clinical performance is satisfactory, but was insufficient to allow their full safety assessment. For all implants, there is insufficient information on their use by women with medical conditions. Provision of contraceptive implants requires good quality family planning services and specific provider training.
Contraception. 2006 Feb; 73(2):195-204.The use of progestogen-only contraceptives among women with sickle cell anemia has generated concerns about possible hematological and other clinical complications. Based on the literature, we assessed whether use of progestogen-only contraceptives is associated with adverse health effects among women with sickle cell anemia. We searched the MEDLINE database for articles published in peer-reviewed journals between 1966 and September 2004 that were relevant to sickle cell anemia and use of progestogen-only contraceptives. Of the 70 articles identified through the search, 8 met the criteria for this review. These studies did not identify any adverse events or clinically or statistically significant adverse changes in hematological or biochemical parameters associated with the use of progestogen-only contraceptive methods. Six studies suggested that users experienced a decrease in clinical symptoms and less frequent and severe painful crises compared with nonusers. Although data are limited, these studies suggest that progestogen-only contraceptives are safe for women with sickle cell anemia. (author's)
Criteria reaffirmed for broad-spectrum antibiotics and hormonal methods, cervical neoplasia and COCs, breastfeeding and progestins.
In: WHO updates medical eligibility criteria for contraceptives, by Ward Rinehart. Baltimore, Maryland, Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, Information and Knowledge for Optimal Health Project [INFO], 2004 Aug. 6. (INFO Reports No. 1; USAID Grant No. GPH-A-00-02-00003-00)Case reports have raised suspicions that broad-spectrum antibiotics in general might lower the effectiveness of hormonal contraceptives. Still, studies find that various broad-spectrum antibiotics do not lower hormone levels and, with one early exception, they have found no evidence of ovulation. Pregnancy rates are similar among women taking COCs alone and women taking both COCs and antibiotics. The 2003 Expert Working Group left broadspectrum antibiotics in MEC category 1 (use in any circumstances). The MEC previously categorized use of the antibiotics rifampicin and griseofulvin both as category 3 (not usually recommended) for most hormonal contraceptives because these drugs were thought to reduce contraceptive effectiveness. There are reports of pregnancies in users of hormonal contraceptives taking griseofulvin, and griseofulvin affects liver enzymes in mice, suggesting a possible impact on hormone metabolism. There are no published clinical or pharmacokinetic studies on interaction between griseofulvin and contraceptive hormones, however. The Expert Working Group reclassified use of griseofulvin to category 1 for users of combined or progestin- only injectables and category 2 (generally use) for users of other hormonal methods. (excerpt)
Geneva, Switzerland, WHO, 1978. (World Health Organization Technical Report Series No. 619) 54 pStudies on steroid contraception (SC) and risk of neoplasia are reviewed. Methodological issues in neoplasia etiology studies include: 1) possibility of a latent period between exposure to cause and disease development; 2) cumulative effects of prolonged or repeated SC exposure; 3) discontinued drugs or dosage schedules; 4) time of exposure (adolescence or prenatal, e.g.); 5) isolation of specific causes among multiple risks; and 6) variations in neoplasma diagnoses. The 4 epidemiological approaches to SC-associated neoplasia studies have inherent shortcomings, but cohorts yield significant associations. Relative risk (ratio of disease incidence among exposed vs. nonexposed persons) is an index of association only, not evidence of cause and effect. Benign breast neoplasia risk was reduced by current SC use of >2 years, and weak evidence points to a residual protective effect, apparently associated with progestogen dose. Aggregated breast cancer data show no clear adverse or beneficial effect of SC use; however, evidence suggests SCs may increase breast cancer risk in population subgroups (e.g., young women). Only short-term evidence is available; hence, no inference of long-term SC breast cancer effects is possible. No beneficial effect of SCs on uterine fibroids is evident, but sequential SCs, no longer marketed, may have increased risk to endometrial carcinoma. Inconclusive data suggest SCs may decrease ovarian cancer risk. Increased risk of cervical dysplasia and carcinoma in situ is associated with SC use, especially long-term use by women with predisposing factors. Risk of hepatocellular adenoma of the liver increases with prolonged SC exposure, especially high dose. Relevance of existing data from more developed countries to disease risk in less developed ones is discussed, and recommendations made.
Family Planning Perspectives. 1999 Jan-Feb; 31(1):49-50.The World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormonal Contraception found no evidence of increased cardiovascular risk in women who used oral or injectable progestogen-only contraceptive methods. The analyses were based on 3697 women with cardiovascular disease from 21 centers in 17 countries in Africa, Asia, Europe, and Latin America. Women with a history of hypertension were at increased risk of stroke, regardless of their use of a hormonal contraceptive, but this pattern did not apply to venous thromboembolism or heart attack. Use of progestogen-only methods was associated with small but nonsignificant increases in cardiovascular risk among smokers. Many of the risk estimates in this study had wide confidence intervals because of the small numbers of users of progestogen-only methods enrolled at the various study centers. The interaction between progestogen-only contraceptives and hypertension merits further assessment, especially because women with a history of high blood pressure use progestogen-only pills more frequently than combined oral contraceptives.
ENTRE NOUS. 1991 Dec; (19):15.About 8 million women use the long acting injectable contraceptive depot-medroxy-progesterone acetate (DMPA) and norethisterone enanthate (NET-EN). These progesterone only injectables are not dependent on sexual activity and are easy to administer. Yet they are not always well accepted since they can interfere with menstrual bleeding and often induce amenorrhea. Researchers find that adding estrogen to DMPA and NET-EN treats these irregularities. They must use esters with limited action to protect the endometrium from constant estrogens, however, which requires monthly injections. Thus bleeding occurs once a month just like the normal menstrual cycle. Clinical trials in China of Injectable No. 1 (250 mg 17-alpha-hydroxyprogesterone caproate and 5 mg estradiol valerate) show that it has few side effects and is acceptable. Other trials in China are evaluating monthly injectables with NET-EN or megestrol acetate. Numerous developing countries often as WHO's Special Programme of Research in Human Reproduction for effective, safe, and fully studied monthly injectables. WHO operates under a 2 part strategy: optimum improvement of HPR 102 (50 m NET-EN and 5 mg estradiol valerate) and Cyclofem (25 mg DMPA and 5 mg estradiol cypionate) resulting in a reduction of the dose of at least 1 of the hormones and results of a study of the efficacy and side effects of these 2 injectables. It hopes the study provides the impetus to introduce them into national family planning programs. It demonstrates that they are indeed efficacious, effect fewer changes in the menstrual cycle than the progesterone only injectables, and are well accepted, even though women must go to a clinic every 27-33 days for an injection. Other studies are determining their effects on lipid and glucose metabolism, coagulation, and fibrinolysis. They are also looking at the time needed for ovulation to return. 1 study shows that menstruation returned in all women by the 3rd cycle.
IPPF MEDICAL BULLETIN. 1987 Apr; 21(2):1-2.Within the past 25 years, steroidal preparations have become available that allow the user contraceptive protection over extended periods of time. There are only 2 injectable preparations presently used at all widely within family planning programs throughout the world: 1) depot medroxyprogesterone acetate (DMPA), and 2) norethisterone enanthate (NET-EN). 1 of the major side effects of progestagen-only contraception has been disruption of normal menstrual bleeding, giving rise to both irregular bleeding and amenorrhea. Several extensive reports on the clinical use of monthly injectables appeared in 1970, but few studies have been reported subsequently. In response to the demand from certain populations to have safe, well-investigated, once-a-month injectable contraceptives with high efficacy and little menstrual bleeding disturbance, the World Health Organization's (WHO) Special Programme of Research in Human Reproduction developed a strategy for the development of a once-a-month contraceptive which involves: 1) the assessment of use-effectiveness and side-effects of HRP102 (NET-EN, 50 mg., plus oestradiol valerate, 5 mg) and Clyloprovera (DMPA, 25 mg., plus estradiol cypionate, 5 mg.); and 2) the optimum improvement of these 2 combined formulas by reduction of the progestagen content. Results from a pharmacokinetic/pharmacodynamic study show that many of the women receiving reduced progestagen dose preparations ovulated during the 3rd treatment month; thus the 2 original preparations, Cycloprovera and HRP102 appear to be the optimal formulations for these combinations of steroids. Plans are being developed to make 1 or both of these available for introduction into certain family planning programs in developing countries early in 1988.
In: Diczfalusy, E., ed. Regulation of human fertility. (Proceedings of the WHO Symposium on Advances in Fertility Regulation, Moscow, USSR, November 16-19, 1976) Copenhagan, Denmark, Scriptor, 1977. p. 323-360Long-acting systemic contraceptives inhibit fertility either at a central or peripheral level. In some instances, a mixed reaction is likely to be working: during the 1st portion of the drug's life-span the contraceptive effect is exerted at a hypothalamic central level, whereas later on--when ovulation is restored--the action is on the cervix or uterus. The most important factor holding back utilization of long-acting agents is serious interference with regularity of the menstrual cycle, and delivery systems must be devised with zero-order release rates to improve cycle control and acceptability. Monthly injectables consisting of synthetic progestins alone proved unsuitable for contraception because of frequent and prolonged amenorrhea. Addition of an estrogenic substance helped cycle control, and a dihydroxyprogesterone acetophenide plus estradiol enanthate combination seems most worthy of clinical investigation; so far, 15,000 woman-months of experience have yielded no unwanted pregnancies. Few bleeding pattern irregularities were reported, but premenstrual tension, dysmenorrhea, and libido changes occurred. Reversibility of drug-induced anovulation has been shown by spontaneous ovulation resumption 12-42 weeks after cessation. Tri-monthly injections of Depo Provera resulted in pregnancy rates averaging .5/100 woman-years of use. Biannual injectable and sustained release systems are discussed and data are presented.
In: Diczfalusy, E. and Borel, U., eds. Control of human fertility. Proceedings of the Fifteenth Nobel Symposium, Sodergarn, Lidingo, Sweden, May 27-29, 1970. New York, Wiley, 1971. 39-51.A drug delivery system providing for a controlled release of progestogen and affecting ovulation and steroidogenesis minimally would deal effectively with some of the problems associated with contraception. 2 systems being developed which fit these criteria are the primary topics of discourse in this article. In 1 system an implant consists of a polymer membrane of polydimethylsiloxane (PDS) and contains the progestogen in crystalline form. Major problems with the PDS implants include a lack of intraindividual constance of release and interindividual variation in the slope of the decay in release. In the second system the implant consists of a lipid-steroid membrane containing a steroid. In this implant the concentration of the steroid in the membrane and the nature of the lipid phase may be important in determining the pattern of release. In vivo metabolic studies with lipid-steroid pellets are limited, but the patterns of output may be similar to those seen with PDS implants. Because of rate problems, a shorter regime slow-release implant seems more feasible than a longer lasting system. Surgical difficulties associated with the implantation and removal of the PDS implant make the choice of a lipid-steroid micropellet preparation more feasible for a short-term regimen. The discussion, following the main body of the article, focuses primarily on problems associated with implants.
Contraception. 1970 Jun; 1(6):409-445.This article reviews the validity of previously published material linking oral contraceptive usage to health hazards. The statistical methods involved in such studies are thoroughly examined, particularly those studies relating oral contraceptive usage to thromboembolic disease incidence. Problems inherent to the basic designs of such studies are discussed. Some relationship between thromembolic disease and oral contraceptive usage has been established. Studies on animals relating oral contraceptive usage with carcinogenesis are inconclusive due to the different metabolic rates obtained for different animals and different strains and the high dosage used to produce tumors. Review of the data relating oral contraceptives with alterations in carbohydrate metabolism, serum lipids, etc., show pure speculation of conclusion. Endrocrine effects persisting after discontinuation of oral contraceptives were rare; apparently both types of steroids play some part. It was suggested that most data on this subject is faulty and filled with fixed opinions which should be avoided.
[Unpublished] . 9 p.Several questions raised by the US Food and Drug Administration (FDA) Public Board of Inquiry on injectable contraceptives are answered by Susan Holck, Ralph Heywood, and Ian Fraser of the World Health Organization (WHO). As to whether human data submitted by Upjohn can refute the risk of human cancer suggested by animal experimentation data the following findings are noted: 1) the preliminary findings of WHO studies do not appear to implicate Depo-Provera as a cause of either in situ or invasive cervical carcinoma but results of further analyses of the existing data will need to be considered before a final conclusion is reached; 2) data from 109 cases of breast cancer and 1812 controls in Thailand do not show that Depo-Provera may increase the risk of breast cancer in women who use this product as a contraceptive; and 3) the numbers of cases of cancer of the uterine corpus, ovary, and hepatobiliary organs are not substantial enough to suggest a public health problem. The 2nd question was whether in the event of contraceptive failure, use of Depo-Provera may increase the risk of teratogenic effects to a greater extent than would other systemic contraceptives. In a clinical trial of 1587 subjects using Depo-Provera the cumulative life table analysis pregnancy rate was 0.1/100 women at 12 months and 0.4/100 women at 24 months, comparing with rates 1.0-3.6/100 women observed with the most commonly used oral contraceptives in another WHO study undertaken in similar populations; contraceptive failures should be relatively uncommon with Depo-Provera use. A WHO scientific group in 1981 noted that there is no evidence that use of Depo-Provera will increase the risk of teratogenic effects to a greater extent than other hormonal contraceptives. 3 limitations which have been encountered in developing research strategies which would provide significant results are: 1) contraceptive failure with Depo-Provera use is rare, so that just a few pregnant women should be exposed to the drug; 2) Depo-Provera is widely used among only a few populations; and 3) the anomalies to be studied are rare.