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PIP: Studies conducted since the introduction of female condoms in the market in 1996 as a strong, soft, transparent polyurethane sheath to protect against HIV/AIDS infection was reported to gain a wide range of acceptability. Men favored its use compared to male condoms since it does not interrupt sexual activity and feels more similar to unprotected sex. Results from international studies on the efficacy of female condoms include: 1) ability to prevent unwanted pregnancies; 2) ability to prevent transmission of sexually transmitted diseases and HIV; 3) expansion of choice in increasing protection; 4) acceptability of the female condom to a wide range of men and women; 4) safety of the product; 5) easier use through constant practice; 6) provision of additional emotional comfort, sense of security and control; 7) cost-effectiveness as a prevention program; and 8) the need for a more strategic introduction in other countries. The establishment of the Female Condom Programming Guide assists with design and implementation of strategies, as well as catalyzing of new ideas and expanding of good practices in female condom programs. This article emphasizes the significance of female condom as an important technology that plays a vital role in the reproductive health programs and needs to be introduced strategically in order to provide the greatest and most cost-effective public health impact.^ieng

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PIP: Contraceptive experts advise the use of low-dose (20-35 mcg estrogen) oral contraceptives (OCs) for perimenopausal patients because of their numerous advantages over hormone replacement therapy. Benefits include effective contraception, regular menses, treatment of menorrhagia and dysmenorrhea, reduction of vasomotor symptoms, higher bone density and fewer fractures, and prevention of ovarian and endometrial cancers. Although age limits for OC use for healthy nonsmoking women have been lifted for some time, certain providers still hesitate to prescribe OCs. Moreover, epidemiological studies confirm that low-dose pills are safe for healthy, nonsmoking women with normal blood pressure. More definitive research also found that the increased risk was mainly related to smoking rather than age. Since smoking is an important risk factor in OC use, pill use by smokers over 35 years old is contraindicated. Instead, it is suggested that they use progestin-only pills, IUDs, or barrier contraceptives for birth control. Another research indicates that women who use the pill can decrease their risk of postmenopausal fractures.^ieng

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This study investigated the effects of a low dose oral contraceptive (OC) (Mercilon) on women's satisfaction and quality of life based on a detailed questionnaire. A total of 614 first-time users of oral contraceptives were enrolled by 102 gynecologists for a treatment period of > or = 4 months. The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) was filled in both before and during pill intake. The total quality of life score was significantly increased under OC intake. In contrast to older preparations, modern low dose OCs appear to act favorably on a number of psychological parameters, thus increasing satisfaction with various aspects of daily life and, consequently, improving quality of life.

PIP: A study was conducted to determine the tolerability of a low-dose oral contraceptive (OC) containing 20 mcg ethinyl estradiol and 150 mcg desogestrel (Mercilon) among first-time users and to evaluate its effects on women's satisfaction and quality of life. The study was conducted between January 1997 and May 1998 using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) submitted to 614 first-time users of OCs. Results showed that modern low-dose OCs act favorably on a number of psychological parameters by comparison with older preparations. The total quality of life rating increased significantly with use of OC. The improvement in patient satisfaction and quality of life observed in this study is a significant finding with respect to the matter of OC acceptability and patient compliance.

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The major benefits of modern low-dose oral contraceptives include relative safety and a high degree of efficacy, decreasing the need for abortion or surgical sterilization; reduced risks of bacterial (but not viral) pelvic inflammatory disease and of endometrial and ovarian cancer; improved menstrual regularity, with less dysmenorrhea and blood flow; and, when low-dose combination (not progestogen-only) oral contraceptives are used, reduced acne and hirsutism. Major risks are cardiovascular. Preliminary data from nonrandomized studies suggest that oral contraceptives containing third-generation progestogens are associated with increased risk of venous thromboembolism, particularly in carriers of the coagulation factor V Leiden mutation. The risk of arterial thrombosis, such as myocardial infarction or stroke, may be directly related to estrogen dose, particularly in women who have hypertension, smoke, or are >35 years old. Considering that only users aged >/=30 years who smoke >/=25 cigarettes/d have a higher estimated mortality rate than that of pregnant women, the benefits of oral contraceptives appear to outweigh their risks.

PIP: This article presents the benefits and risks of low-dose oral contraceptives (OCs). Most OCs contain a low-dose combination of ethinyl estradiol (or= 35 mcg) and a progestogen (0.1-1.5 mg, depending on the product type). OCs are relatively safe and effective when used for years; they control fertility in women and facilitate spontaneous sexual activity. Other benefits include: 1) improvement in the regularity of menses; 2) decrease in the incidence of dysmenorrhea; 3) circulation of blood flow; 4) reduction of the risks of ovarian and endometrial cancer; 5) inhibition of rheumatoid arthritis progression from mild to severe; and 6) when using low-dose combination (not progestogen-only) OCs, acne and hirsutism are reduced. However, there are also risks in using OCs. The risks associated with OC use are mostly cardiovascular. OCs containing third-generation progestogens are linked with an increased risk of venous thromboembolism. Moreover, acute myocardial infarction risk is great among smokers with hypertension, particularly among women older than 35 years; however, the risk decreases as the dosage of ethinyl estradiol decreases.

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Many women remain unaware of classic oral contraceptive (OC) noncontraceptive health benefits even as new health advantages emerge from experience and research. An extensive body of evidence has established that OC protect women against dysmenorrhea and menorrhagia, menstrual cycle irregularities, iron deficiency anemia, ectopic pregnancy, pelvic inflammatory disease, ovarian cysts, benign breast disease, endometrial cancer, and ovarian cancer. In addition, the FDA has stated for the first time that an OC-triphasic norgestimate/35 micrograms ethinyl estradiol--is an effective treatment for moderate acne vulgaris. OC use also appears to prevent osteopenia in hypoestrogenic women. In addition to these noncontraceptive health benefits, OC have proven valuable in the management of a variety of gynecologic disorders, including dysfunctional uterine bleeding, persistent anovulation, premature ovarian failure, functional ovarian cysts, pelvic pain (including secondary dysmenorrhea), mittelschmerz, endometriosis, and the control of bleeding in women with blood dyscrasias. Educating healthcare providers and women about these important noncontraceptive health benefits will result in increased compliance, greater continuation, and fewer unintended pregnancies.

PIP: Many US women remain unaware of the noncontraceptive health benefits associated with oral contraceptive (OC) use. An extensive body of research has established that OCs protect women against dysmenorrhea and menorrhagia, menstrual cycle irregularities, iron deficiency anemia, ectopic pregnancy, pelvic inflammatory disease, ovarian cysts, benign breast disease, and endometrial and ovarian cancer. More recent studies have suggested that OCs can be used for the treatment of acne vulgaris and the prevention of osteopenia in hypoestrogenic women. In addition to these classic and emerging noncontraceptive health benefits, many clinicians prescribe OCs for the treatment of common gynecologic conditions such as dysfunctional uterine bleeding, polycystic ovarian syndrome, premature ovarian failure, pelvic pain, mittelschmertz, endometriosis, and control of bleeding in women with blood dyscrasias. If OC acceptors are educated about these benefits, contraceptive compliance and continuation are likely to improve.

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PIP: This article reports on a new single-rod progestin contraceptive implant (Implanon) produced by Netherlands-based Organon NV for market introduction in the US. While Organon considers the timing of Implanon's entrance in the federal Food and Drug Administration (FDA) approval process, Wyeth Ayerst Laboratories of Philadelphia has already FDA clearance in hand to market its two-rod levonorgestrel implant system. However, Wyeth Ayerst continues to conduct additional research. The company's research includes an assessment of potential design, with changes in the trocar insertion device for the two-rod implant being under consideration. Insertion and removal of the single-rod implant system is easier and quicker than with the original six-implant Norplant system. US clinicians and their patients are looking forward to the availability of Implanon.^ieng

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PIP: An article focuses on the influence of social marketing, particularly of condoms and efforts to fight the HIV/AIDS epidemic. Condom sales have increased, especially in Africa. These sales are a good reflection of condoms purchased and used. Concerning the prevention of HIV/AIDS, availability of condoms is the most significant achievement of condom social marketing programs; however, HIV/AIDS prevalence has not declined. The marketing of condoms has been observed to be insufficient compared to the theoretical demand for condoms. All social marketing programs should be focused on marketing and communications, expressing messages that promote safer sexual behavior. Products and services aimed at safe sexual activity are being searched as tools in the fight against AIDS. In Uganda for instance, a kit called "Clear Seven" includes a large dose of pyprofloxin, a seven-day course of doxycycline, seven condoms and partner referral cards. The Population Services International is doing voluntary counseling and testing in Zimbabwe to prevent HIV transmission and contribute to destigmatizing people living with AIDS. It is too soon to assess the effectiveness of the program, yet many countries are already planning to duplicate it.^ieng

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PIP: A recent study suggests that the protective effect of oral contraceptive (OC) use against ovarian cancer extends to women who inherit a faulty gene that places them at risk for this cancer. An estimated 10% of ovarian cancers are attributed to a genetic mutation in the BRCA1 or BRCA2 genes. Researchers at centers in Canada, Sweden, Norway, Italy, England, and the US, compared OC use in 207 women with the inherited form of ovarian cancer and 161 of their sisters, some of whom also had the genetic mutation. Women who had used OCs at any time in the past had an overall 50% lower risk of ovarian cancer; this risk was reduced by 60% if OC use exceeded 6 years. A combined regimen of OC use and prophylactic oophorectomy may be indicated in women with a genetic predisposition to ovarian cancer. The effects of OC use by women with BRCA mutations on breast cancer risk are under investigation.^ieng

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PIP: Each year, about 25,000 new cases of ovarian cancer are diagnosed in the US. Because ovarian cancer has few symptoms in its early stages and there is no effective screening test, most patients have widespread metastases at diagnosis. Epidemiologic studies have demonstrated that OC use can protect against ovarian cancer for at least 15 years after pill use is discontinued. The most likely mechanism of this protective effect is inhibition of ovulation. A strong association between total number of lifetime ovulations and mutation of the p53 gene in ovarian cancers has been reported. Use of the pill for 5 years decreases the risk of ovarian cancer by 40% but decreases lifetime ovulations by only about 15%, suggesting that factors other than prevention of proliferation-associated mutations contribute to the protective effect of ovulation inhibition. The pill also decreases the incidence of endometrial cancer by about 50%. At present, OCs represent the best option for US women from both the contraceptive and cancer prevention perspectives.^ieng

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PIP: A review of the English-language literature related to the association between use of combined oral contraceptives (OCs) and endometrial cancer is used to illustrate the principles of meta-analysis. Guidelines are presented on defining the problem, finding the relevant studies, abstracting the pertinent information, imputing values to duration of use and recency, and analyzing and interpreting the resulting data. The meta-analysis of the epidemiologic literature indicates that combined OC use is associated with a reduced risk of endometrial cancer. There also appears to be a residual protective effect that persists long after discontinuation of OC use. The absolute reduction in risk is inconsequential at the individual level, however. A US woman's probability of remaining free of endometrial cancer through age 74 years increases from 97.6% in the absence of OC use to 98.6% after 12 years of OC use. Although meta-analyses can provide a quantitative perspective on findings in the literature, they cannot distinguish between correlation and causation.^ieng

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It was hypothesized that estrogen-induced cardioprotection is mediated by up-regulation and down-regulation of expression of nitric oxide (NO) and P-selectin, respectively. Published data on circulating levels of the vasodilator NO, atherogenic glycoprotein P-selectin, and lipoprotein-a [Lp(a)] in users of triphasic contraceptive steroids are lacking. A total of 30 healthy women (nonusers, controls) and 82 women using oral triphasic contraceptive steroids (ethinyl estradiol and levonorgestrel: Triovlar, Schering AG) for 18 to 24 cycles participated in this study. Fasting blood samples were obtained from users and nonusers for the determination of P-selectin and Lp(a) by enzyme immunoassay and NO by a colorimetric method. The serum Lp(a) levels in OC users were significantly higher than those of nonusers. On the other hand, the serum NO levels in OC users were significantly elevated when compared to nonusers. Plasma P-selectin was significantly lowered in OC users p < 0.005. These results demonstrate the beneficial effects of ethinyl estradiol in the triphasic contraceptive regimen. Ethinyl estradiol may afford a degree of anti-atherogenic-cardioprotective effect by up-regulation of the expression of the vasodilator NO and down-regulation of the expression of the atherogenic P-selectin. This may outweigh the cardiovascular risk of the increased atherogenic Lp(a). This study may explain the very low rate of mortality from venous thromboembolism in OC users, which compares favorably with the risks that many people accept in daily life.

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Several authors have suggested that estrogen may serve to protect skeletal muscle from exercise-induced damage. The present study examined the effects of regularly ingesting estrogen, in the form of oral contraceptives, on postexercise muscle damage following a bench-stepping regimen. Women currently ingesting oral contraceptives (OC) were compared with eumennorheic controls (CG). All subjects performed a 50-min stepping exercise during the midluteal phase of their menstrual cycle. Muscle damage was evaluated on 2, 3, and 5 days postexercise using several established indirect indicators: perceived soreness, strength and range of motion changes, girth measurements, and creatine kinase (CK) activity. Subjects on OC reported significantly lower quadriceps soreness (p < 0.05) relative to the CG (peak soreness = 4.0 and 7.8, respectively, on a scale of 1-10 where 1 is normal and 10 is very, very sore). These results indicate that oral contraceptive use attenuates soreness following an exhaustive stepping activity but cannot support a relationship between estrogen ingestion and other indices of exercise-induced muscle damage.

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OBJECTIVE: The possibility that oral contraceptives offer a protective effect against the development of rheumatoid arthritis is still contentious. Of the 17 studies investigating this association, 11 have found a protective effect, and 6 have not. These differences are probably attributable to either selection or information biases in a subset of studies, although the exact reason is unknown. To overcome the methodological problems inherent in the design of previous studies, we have conducted a population-based case-control study. METHODS: Women who were incident cases of inflammatory polyarthritis, defined as swelling of at least two joint areas lasting at least 4 weeks, were recruited directly from primary care and compared with age-matched women from the same population. RESULTS: Cases and controls reported a similar level of "ever use" of oral contraceptives, adjusted odds ratio = 0.88 (95% confidence interval, 0.47, 1.64). The cases were, however, less likely to report using oral contraceptives at the time of onset, adjusted odds ratio = 0.22 (95% confidence interval, 0.06, 0.85). Similar results were observed for cases who satisfied the criteria for rheumatoid arthritis and cases who did not. CONCLUSION: These results indicate that only current oral contraceptive use protects against the development of inflammatory polyarthritis.

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The aim of the study was to investigate if bacterial vaginosis (BV) is associated with use of specific contraceptives. Women at family planning and youth clinics (n = 956), among whom 131 had BV, were subjects for structured in-depth interviews including current and previous contraceptive use. Variables measuring sexual risk-taking were ascertained. Current users of contraceptives were compared with non-users. Both oral contraceptive (OC) and condom use showed a significant protective effect against BV, adjusted for possible confounders (odds ratios were 0.4 and 0.3, respectively). Intrauterine device use (IUD) showed no association with BV. Women with BV had less often used any contraceptives, including condom, at their sexual debut than the women in the comparison group. In this study, OC and condom use seemed to exert a protective effect against BV, whereas no effect for IUD use was found.

PIP: To determine whether bacterial vaginosis (BV) is associated with use of specific contraceptive methods, 956 women from family planning and youth clinics at 3 Swedish hospitals were enrolled in a cohort study. 131 women had at least 3 of the 4 clinical signs of BV: a homogenous gray vaginal discharge, a vaginal pH of 4.7, a positive amine test, and the presence of "clue" cells. Age at first intercourse was 16 years among those with and without BV; however, 8.4% of women with BV, compared with only 1.7% of controls, had had more than 1 sex partner in the last 6 months. Other factors associated with BV were more than 10 lifetime sex partners, non-use of contraception at first intercourse, a history of sexual abuse, an induced abortion, smoking, and alcohol consumption. After adjustment for sexual risk-taking, there was a significant negative association between BV and oral contraceptive (OC) use (odds ratio [OR], 0.4; 95% confidence interval [CI], 0.2-0.8). There was also a significant negative association with condom use (OR, 0.3; 95% CI, 0.1-0.9). There was no association between BV and IUD use, before or after adjustment for confounding factors. Insufficient numbers of diaphragm or spermicide users were available for analysis. The finding of an apparently protective effect against BV of OCs and condoms lacks a biological explanation at present, although it is speculated that OC use increases the glycogen content of vaginal epithelial cells, in turn inhibiting the in vitro growth of certain bacteria.

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Pregnancy rates among adolescents have not decreased over the last 10 years, despite numerous efforts. To solve this important health problem, the major strategy recommended is to encourage contraceptive use among sexually active teenagers. An important means of obtaining this is by promoting methods that are not dependent on daily administration in order to avoid noncompliance. One such method (Norplant) has already shown to be much more effective than the combination pill in preventing pregnancy in adolescent women. The frameless intrauterine implant system (fixed, frameless, and completely flexible) has been studied since 1985 in women between 14 and 50 years of age. The results in young nulligravid women confirm its very high effectiveness (cumulative pregnancy rate at 36 months: 1.4%), its low expulsion rate (cumulative rate at 36 months: 0.9%) and its optimal tolerance (cumulative removal rate for medical reasons at 36 months: 2.4%), resulting in a high acceptance of the implant and a high continued use. The system (GyneFix) offers long-term protection (5 years), and its insertion, with or without anesthetic, is easily accomplished in the office. The GyneFix should therefore be recommended as an excellent alternative for birth control pills for young women with low risk for STDs, especially when compliance is a problem, without an increased risk for complications and without systemic side effects. Removal of the device is accomplished by traction on the tail. It can also be used for emergency contraception and for insertion immediately after termination of pregnancy.

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PIP: Vaginal sponges offer women control over protection against both pregnancy and sexually transmitted diseases (STDs), including HIV. Spermicide-impregnated sponges combine the actions of a physical barrier that blocks the cervix with a material that absorbs the ejaculate and a spermicide. Commercially available spermicides contain 1-5% of nonoxynol-9, shown to inhibit organisms responsible for gonorrhea, chlamydia, candidiasis, genital herpes, syphilis, trichomoniasis, and HIV. On the other hand, nonoxynol-9 is associated with a significantly higher risk of vaginal colonization with bacterial agents, ulcerative genital diseases, and vulvitis. A lower dose of nonoxynol-9 appears to avert vaginal irritation without compromising contraceptive efficacy. Use of chlorhexidene, a spermicide less irritating to mucosal cells than nonoxynol-9 but active against HIV in vivo and in vitro, is under investigation. Also promising are initial findings regarding the Protectaid contraceptive sponge with F-5 gel. Epidemiologic studies and clinical trials should provide quantitative estimates of the level of protection offered by barrier methods and identify the method that combines the highest protection, ease of use, and user acceptability.^ieng

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The Levonorgestrel-releasing intrauterine device (LNG IUD) provides excellent contraception; it may reduce the rate of pelvic inflammatory disease (PID) and ectopic pregnancy compared to other 'modern' copper releasing IUDs; it can safely be used in the puerperium for breast-feeding mothers, and it significantly reduces menstrual blood loss and pain. While it was developed primarily as a contraceptive, its potential role in managing heavy and painful menstruation and the symptoms of the climacteric may eventually be just as important. Amongst developed countries New Zealand and Australia have some of the highest hysterectomy rates. By the age of 50 years 1 in 4 women in New Zealand and 1 in 5 women in Australia will have had a hysterectomy (A,B). In New Zealand 90% of these are performed for heavy menstrual bleeding and fibroids (A). The LNG IUD has been shown to be effective treatment for both these conditions and its introduction to New Zealand and Australia would offer women an additional choice beyond surgery.

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We aimed to measure the effectiveness of latex condoms and of nonoxynol-9 [N-9] spermicides, in preventing HIV transmission in heterosexual serodiscordant couples in Lusaka. Each couple was examined at clinic visits scheduled at 3-month intervals for one year or more per couple, or until seroconversion or discontinuation. Couples were given condoms and their choice of 3 N-9 products and advised to use both at every intercourse. Sexual exposure was ascertained from coital logs that recorded coitus and barrier method use. HIV serological testing was done at each clinic visit (ELISA and Western blot if positive). One hundred and ten discordant couples were followed for a mean of 17.6 months. Seventy-eight per cent of coital episodes were protected by condoms, 85% by spermicides and 6.4% were unprotected. Fourteen seroconversions occurred (8.7 infections per 100 couple-years [c-y]). The rate was higher among seronegative men than seronegative women. Among couples who reported using condoms at every intercourse the infection rate was 2.3/100 c-y, compared with 10.7/100 c-y among couples using condoms less consistently (rate ratio [RR] 0.2; 95% confidence interval [CI] 0-1.6). Among couples who reported using N-9 at every intercourse, the seroconversion rate was 6.9/100 c-y; among couples who reported less than full-time N-9 use, the rate was 8.9/100 c-y (RR 0.8; 95% CI 0.2-2.8). Among the subset of female seronegatives, the N-9 RR was 0.5 (95% CI 0.1-3.8). But when we calculated HIV rates according to N-9 consistency in coital acts when condoms were not used, there was no evidence of protection with higher N-9 use. Consistent use of latex condoms reduces the incidence of HIV infection, but the association between N-9 spermicides and HIV is less clear. The current study could not provide compelling data on the impact of N-9 spermicide use on risk of HIV infection. The study's small size, as well as the consistency of concurrent condom use, limited our inferences. Available spermicide products must be studied further.

PIP: The protective effect of consistent condom use against HIV transmission in HIV-serodiscordant couples has been documented. Unknown, however, is the anti-HIV effect of nonoxynol-9 use. This issue was addressed in a survey of 110 HIV-discordant couples from Lusaka, Zambia, who were willing to use condoms/spermicide, maintain a coital log, and return for follow-up visits every 3 months for at least 1 year. 80 of these couples (73%) had a seropositive man and 30 (27%) had a seropositive woman. The mean duration of follow-up was 17.6 months. Of the total of 15,148 recorded coital episodes, 10% were protected by condoms only, 17% by nonoxynol-9 only, 66% by both condoms and nonoxynol (according to the study protocol), and 6% were unprotected by any barrier method. Consistent barrier method use declined with duration of follow-up. There were 14 seroconversions (8.9 infections/100 couple-years), including 8 initially seronegative men and 6 initially seronegative women. Among couples who used condoms 0-50%, 51-75%, 76-99%, and 100% of the time, the seroconversion rates were 20.8, 10.1, 7.3, and 2.3/100 couple-years, respectively. Seroconversion rates were 6.9 and 8.9/100 couple-years among those reporting consistent and inconsistent use, respectively, of nonoxynol-9. Although this study failed to provide evidence that nonoxynol-9 use confers significant protection against HIV infection, its small size and the consistency of concurrent male condom use limited inferences.

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PIP: The Population Council is currently conducting 4 clinical trials of the vaginal contraceptive ring. This device remains in the vagina for weeks or months, releasing hormone formulations tailored for a variety of contraceptive needs. Rings that deliver both estrogen and progesterone can be kept in place for 3 weeks, then removed for the last week of the cycle. Since the steroids diffuse directly from vaginal tissues to the bloodstream, smaller steroid doses can be used than for oral contraceptives (OCs). In contrast to IUDs, which require insertion and removal by medical providers, women can be taught to insert and remove the flexible device themselves. One of the rings being evaluated by the Population Council is suitable for breast feeding women. It does not contain estrogen and appears to have no adverse effect on either lactation or infant growth. Preliminary findings have confirmed the effectiveness of a ring that remains in place 6-12 months. Advantageous for distribution in developing countries would be a contraceptive ring that lasts for 12 months and could be priced competitively with OCs. In addition to contraception, the ring can be used by postmenopausal women for hormone replacement treatment.^ieng

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Consistent reports from several recent studies suggest that users of third generation oral contraceptives (OCs) containing gestodene and desogestrel may be at increased risk of venous thromboembolic disease (VTE). Paradoxically, other reports indicate that these users may be at decreased risk of acute myocardial infarction (MI) compared with users of second generation OCs. To determine whether the potentially increased risk of VTE would outweigh the potentially reduced risk of MI in users of third generation OCs, we conducted an analysis to quantify the trade-offs providers and users may be faced to make between these formulations. The baseline rates of VTE and MI among non-users were calculated using US data on incidence and mortality of these conditions and estimates of the proportion of women exposed to these formulations in the US. These were multiplied by relative risks published in recent studies on third generation progestins to produce age- and formulation-specific risks. Results indicate that there would be small differences in disease burden between users of second and third generation OCs under the model assumptions at younger ages. However, among women 35-44 years of age, modeling results indicate that the potentially decreased incidence of MI among users of third generation OCs more than offsets the potentially increased risk of VTE at this age.

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