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PubMed2004

Assessment of contraceptive vaccines based on recombinant mouse sperm protein PH20.

Mouse PH20 (mPH20), the mouse homologue to guinea pig hyaluronidase protein PH20 (gpPH20), was used to produce contraceptive vaccines that target both sexes of mice. Previously, immunization with a female gamete antigen (the zona pellucida subunit 3 protein) delivered in a recombinant murine cytomegalovirus (MCMV), or as a purified recombinant protein, has been shown to induce infertility in female mice. There is evidence, however, that sperm protein antigens could provide broader contraceptive coverage by affecting both males and females, and the most promising has been gpPH20 when tested in a guinea pig model. Mice were therefore either inoculated with a recombinant MCMV expressing mPH20 or immunized directly with purified recombinant mPH20 protein fused to maltose-binding protein. Mice treated with either vaccine formulation developed serum antibodies that cross-reacted to a protein band of 55 kDa corresponding to mPH20 in Western blots of mouse sperm. However, there was no significant reduction in the fertility of males or females compared with control animals with either formulation. We conclude from our data that recombinant mPH20 is not a useful antigen for inclusion in immunocontraceptive vaccines that target mice.

Animals↗
PubMedDate not supplied

Evaluation of the efficacy of a nonlatex condom: results from a randomized, controlled clinical trial.

CONTEXT: To reduce unintended pregnancy and HIV infection, it is critical to develop reliable male condoms that will attract consumers who reject conventional latex condoms. METHODS: In a prospective clinical trial conducted in 1998-2000, 830 monogamous couples were randomized in equal numbers to use either a nonlatex condom or a commercial natural latex condom for six months as their only method of birth control. Couples completed detailed reports for the first five condom uses and recorded intercourse and condom use in coital diaries. Pregnancy rates associated with typical and consistent condom use were calculated using life-table analysis. Rates of clinical failure (condom breakage or slippage) were determined for the first five condom uses. RESULTS: During the first five uses, the nonlatex condom had a higher frequency of breakage or slippage during intercourse or withdrawal (4.0%) than latex condoms (1.3%); the breakage rate for the nonlatex condom was about eight times that of latex condoms. The six-cycle typical-use pregnancy rate did not differ significantly between users of nonlatex (10.8%) and latex condoms (6.4%). The six-cycle consistent-use pregnancy rate was higher for nonlatex condom users than for latex condom users (4.9% vs. 1.0%). CONCLUSIONS: The data present strong indirect support for public health messages that promote the use of latex condoms and, for individuals who cannot or are unwilling to use latex condoms, the use of nonlatex condoms for prevention of pregnancy and disease.

Adult↗
PubMed1998

Contraceptive knowledge: development of a valid measure and survey of pill users and general practioners.

AIMS: To design, pilot, and validate a questionnaire to test contraceptive knowledge in combined oral contraceptive pill users. METHOD: To ensure face and content validity the questionnaire was developed using existing unvalidated instruments and in consultation with GPs, local and national family planning experts, and with pill users. The questionnaire was then piloted with 15 current oral contraceptive pill users and 10 local GPs, modified, and a contraceptive knowledge 'score' developed. Construct validity-that the degree of family planning training should predict contraceptive knowledge-was tested in four groups: family planning trainers (n=28), GPs (n=40), current pill users (n=53), and male medical students (n=59). Thirty current pill users were sent the questionnaire after two weeks to determine test-retest reliability. RESULTS: The questionnaire showed construct validity: there was a gradient of scores across the four knowledge groups. Family planning trainers had the highest scores, followed by GPs, and current pill users, with male medical students having the lowest scores (Kruskal-Wallis test p<0.001). Women had good knowledge of situations when pill efficacy is reduced but poorer knowledge of what action to take subsequently. Predictors of knowledge in pill users were educational level, age, and the importance attached to not falling pregnant-thus providing further evidence for the construct validity of the questionnaire. Test-retest reliability was good (rank correlation 0. 73). CONCLUSION: A contraceptive knowledge questionnaire suitable for use in audit or research has been developed which is reliable and has face, content and construct validity. Pill users have poor knowledge of what to do in situations of pill failure and about the details of emergency contraception. Trials are needed to assess the effectiveness of different strategies to improve contraceptive knowledge in women.

Adult↗
PubMed2002

Oral contraception: trends over time.

Since their introduction in 1960, oral contraceptives have undergone an evolution in content and dosage. The doses of the steroid components of combination oral contraceptives have been dramatically decreased since the first formulations. Ethinyl estradiol is now used as the estrogenic component of most combination oral contraceptives. The majority of progestins currently used in combination oral contraceptives are derivatives of 19-nortestosterone. However, drospirenone, which is combined with ethinyl estradiol in a new combination oral contraceptive, is a novel progestin that is derived from 17 alpha-spirolactone and is an analogue of spironolactone. The extremely low failure rate with ideal use of combination oral contraceptives is seldom duplicated in actual usage. Women often discontinue combination oral contraceptives within the first 2 months due to side effects that would likely have decreased over time. Although there are some areas of increased health risk with combination oral contraceptives, the benefits far outweigh the potential risks. In addition to providing effective contraception, combination oral contraceptives are sometimes used for their many noncontraceptive health benefits--e.g., treatment of menstrual irregularities and management of premenstrual symptoms. The most practical solution to the problem of poor compliance appears to lie in providing adequate education and counseling to women using combination oral contraceptives so that they know how to use them properly and what side effects they might expect. Patients also need to be given the facts about potential increases in the risk of certain conditions to help correct any misperceptions.

Adult↗
PubMed1998

Contraceptives: regional perspectives, issues, and unmet needs--the European perspective.

Existing methods of contraception clearly do not meet all the needs of European women. Studies have shown that women continue to want contraceptive methods with the lowest possible risks and highest possible health care benefits. In addition to offering health benefits, these methods must have extremely low failure rates and permit good compliance. Studies reflect high rates of non-compliance and discontinuation with the combined OC and the progestogen-only contraceptive pill. Methods, such as the IUDs, subdermal implants, and injectable contraceptives offer significant advances in continuation of contraception coupled with low failure rates. In the past, the use of injectable contraceptive methods in Europe was low because only the progestogen-alone methods were available - Depo-Provera and Noristerat. Both methods have been linked with extensive menstrual cycle disturbance, which has not been noted with the combined injectable methods, as reviewed by Newton et al.. The author believes that combined injectable methods should be added to the list of contraceptive methods freely available to women in Europe, not only because of their lack of disruption of the menstrual cycle, but also because of their high efficacy, good cycle control, and other health benefits. This method may prove extremely useful over the next 10-20 years. Market surveys will determine whether combined monthly injectables are perceived by potential contraceptive users as having health benefits, and focus group discussions will allow an appropriate range of contraceptive products to be available. These should increase patient choice and allow clinicians to make available a wider range of products for those seeking contraception.

Abortion, Legal↗
PubMed2003

Efficacy of the female condom as a barrier to semen during intercourse.

In 1996-1998, the authors measured prostate-specific antigen (PSA) in vaginal fluid to assess the frequency of female condom failure and to evaluate the association of self-reported failure with semen exposure. Women at low risk of sexually transmitted diseases (n = 210) were recruited in Birmingham, Alabama. They were trained to use the female condom, sample vaginal fluid before and after condom use, and complete forms to report problems during each use. Semen exposure was assessed by comparing pre- and postcoital PSA levels in vaginal fluid. A total of 175 women used 2,232 condoms. The rate of semen exposure ranged from 7% to 21% of condom uses, depending on the exposure criterion. Exposure was more likely (21-34%) and more intense (mean postcoital PSA, 24.7 ng/ml) if participants reported a mechanical problem versus other problems or no problems (exposure rate, 5-20% in both instances; mean postcoital PSA, 9.6 and 7.8 ng/ml, respectively). In logistic regression analyses for repeated measurements, user-reported problems accounted for less than 59% of the instances of semen exposure. The female condom prevented semen exposure in 79-93% of condom uses. Exposure was associated with user-reported problems but also occurred in their absence. Reported problems and semen exposure decreased with user experience.

Adult↗
PubMed2005

Barrier and spermicidal contraceptives in adolescence.

This article describes both barrier and spermicide methods of contraception including the male and female condom, diaphragm, contraceptive sponge, Lea Shield, cervical cap and multiple spermicide options. Their efficacy, differences and proper use are discussed with an emphasis on the adolescent user.

Adolescent↗
PubMed2002

Induction and immunohistology of autoimmune ovarian disease in cynomolgus macaques (Macaca fascicularis).

Autoimmune ovarian disease (AOD) is a probable cause of human premature ovarian failure, and a potential complication of contraceptive vaccines based on ovarian antigens. The diagnosis depends on detection of noninfectious ovarian inflammation (oophoritis) and serum antibody to ovarian and placental antigens. Mechanisms underlying AOD have been investigated in mice but not in primates. Herein, we report induction of AOD in primates, and compare the immunopathology between monkey and murine AOD. Four cynomolgus macaques immunized with monkey or human zona pellucida 3 peptide (pZP3) in adjuvant, developed T-cell responses to the immunizing peptide and produced antibody that bound to native zona pellucida in vivo. Immunostaining of ovaries from pZP3-immunized macaques showed numerous clusters of T cells co-localized with major histocompatibility complex II-positive macrophages in the ovarian interstitium. Such foci were not detected in untreated or adjuvant-treated control monkeys. This finding is comparable to murine pZP3-induced AOD. However, unlike murine AOD in which numerous granulomatous lesions are detected, severe granulomatous inflammation was detected in only one of three monkeys with abnormal immunohistology. Similar to mice with pZP3-induced AOD, the immunized monkeys retained normal ovarian function. The results are discussed in the context of complications of ZP-based human immunocontraceptive vaccines and case reports of human autoimmune oophoritis.

Animals↗
PubMed1995

Venous and pulmonary thromboembolism: an algorithmic approach to diagnosis and management.

The frequently encountered disorder of venous thromboembolism (VTE) can cause serious morbidity and even death. Nevertheless, in more than 70% of patients who die of pulmonary embolism (PE), the diagnosis is not considered before death. Thus, clinicians should have a high index of suspicion for VTE, especially in high-risk patients. Some risk factors for VTE are a recent surgical procedure and general anesthesia, immobilization, congestive heart failure, previous PE, pregnancy, and oral contraceptive use. Before therapy can be initiated, a definitive diagnosis of VTE must be established. An algorithm for assessing patients with possible VTE is presented; decisions about proceeding with various studies are based primarily on the clinician's degree of suspicion for the presence of PE and the findings on a ventilation-perfusion scan. Elevation of the patient's legs before, during, and after a surgical procedure is a simple measure that may substantially decrease the occurrence of PE.

Algorithms↗
PubMed2001

Expulsions following 1000 GyneFix insertions.

CONTEXT: The GyneFix intra-uterine device has been used in our family planning service since 1997. One of the perceived advantages is its low expulsion rate, as reported by clinical trials. OBJECTIVE: To calculate expulsion rates in routine clinical use and to look at possible reasons for expulsion. DESIGN: Retrospective casenote analysis and opportunistic client consultation. SETTING: A city centre family planning clinic. PARTICIPANTS: The first 1000 GyneFix insertions. MAIN OUTCOME MEASURES: Parity of client, experience of clinician carrying out insertion, time from device insertion to expulsion. RESULTS: Overall expulsion rate was 7.6%. There was no significant difference in parity of clients experiencing expulsion. Most (4.7%) expulsions were early, occurring within 3 months of insertion. There was considerable variation in early expulsion rate from one clinician to another. Later expulsions also occurred, up to 28 months after insertion. Increasing experience of the inserting clinician led to lower rates of late expulsion. Unnoticed expulsion led to four unplanned pregnancies. CONCLUSIONS: The GyneFix expulsion rate in our service is higher than quoted in clinical trials. Early expulsions may be related to insertion technique, representing insufficient implantation of the anchoring knot into the fundal myometrium. Late expulsions also occur, often many months after insertion; the reason for these is unclear. Users should be taught to check for the presence of the thread after each menstrual period and unnoticed expulsion should be confirmed by ultrasound and abdomino-pelvic plain X-ray.

Contraception↗
PubMed1998

[Thrombophilic states].

Thrombophilia is defined as an increased tendency to thrombosis and can be inherited or acquired. The thrombotic events in patients with inherited thrombophilia tend to occur at a young age, are often idiopathic, recurrent and may occur at unusual sites (e.g. mesenteric, portal and cerebral veins and in inferior vena cava). The most common of the hereditary defects appear to be antithrombin, protein C, protein S deficiency, which account for 10% of individuals presenting with venous thromboembolism, resistance to anticoagulant effect of activated protein C (APC-R), which is present in 17 to 64% of patients with thrombosis and prothrombin 20210 G-->A variant with 6% prevalence in patients with thrombosis. APC-R is due in 90% to the presence of factor V Leiden. Rarer defects include heparin cofactor II (HC II), plasminogen or tissue plasminogen activator deficiency (TPA), elevated plasminogen activator inhibitor-1 (PAI-1) and dysfibrinogenemia. The most common acquired defects are antiphospholipid antibodies (lupus anticoagulant and anticardiolipin antibodies). Hyperhemocystinemia is responsible as well for arterial as venous thrombosis. A substantial proportion of venous thrombotic events occurs spontaneously, i.e. without a precipitating event. Risk factors for thrombosis include surgery, trauma, immobility, congestive heart failure, pregnancy including puerperium and oral contraceptive usage. The thrombotic risk is increased in patients who are homozygous for factor V Leiden and markedly increased in patients with combined defects.

Female↗
PubMedDate not supplied

Birth-rate re-appraisal in southern Africa.

The birth rate may not be slowing as fast as originally thought in Botswana and Zimbabwe, the two Sub-Saharan countries believed to be making the best progress towards curtailing population growth. A new study from the World Bank has re-examined the evidence on which the claims of fertility decline were based, and concluded that the figures may have been misinterpreted. Two censuses, carried out in 1984 and 1988, revealed a steep drop in the birth-rate. But the bank study shows that the two surveys are no longer compatible, because the later one questioned better-educated women. Women who have more schooling are more likely to be using contraceptives, regardless of the success or failure of a country's family planning program. This means that projections for the size of the two countries' populations have certainly been underestimated. "Among women aged 25 to 34 years in Zimbabwe in 1984, between 20% - 50% of the observed fertility-decline can be attributed to differences in education across the surveys; between 20% - 30% of the decline among women aged 35 to 44 years in Botswana can similarly be explained," the report says.

Africa↗
PubMed2003

Biological safety testing of polymers.

The extent of testing polymer-containing medical devices is subject to a range of considerations and needs to be determined on a case-by-case basis. This article reports on recent areas of concern for device materials including biodegradation and immunogenicity potential.

Absorbable Implants↗
PubMed1987

[Fulminant liver failure in tuberculostatic therapy. A contribution to clinical aspects and pharmacokinetics].

A 23-year old female patient on a prolonged regimen of tuberculostatic chemotherapy finally developed fulminant hepatic failure shortly after addition of hormonal contraception. The pathophysiology of this almost fatal drug reaction is described as a pharmacokinetic interaction: the inherent hepatotoxicity of prothionamide-the drug finally prescribed during convalescence-was significantly potentiated by the Cyt-P-450-inducing effect of the progestagen component of the hormonal contraceptive. Potentiation of hepatotoxicity in connection with tuberculostatic regimes containing rifampicin is well known and this pharmacokinetic phenomenon also pertains to the combination with other Cyt-P-450-inducing drugs such as, for instance, anticonvulsants. However, since the maximum of rifampicin-related Cyt-P-450-inducing effect is limited to the initial 2-3 weeks of therapy, the hepatotoxic risk triggered by this rifampicin-related induction may decline during continuation of therapy. This, unfortunately, does not pertain to the other Cyt-P-450-inducers, whose inductive effect is not time-limited. Progressive severe hepatic damage may follow from such interaction as demonstrated in this case report.

Adult↗
PubMed2004

[Emergency contraception: user's profile in primary care emergency services].

OBJECTIVES: To establish the emergency contraception (EC) users profile and whether she perceives this type of contraception as an emergency. Design. Cross sectorial study (over one year period: March 2002-March 2003). SETTING: Emergency Services in Primary Care. Usera and Carabanchel; 11th Area; Madrid. PARTICIPANTS: Women requesting EC in these centres. MAIN OUTCOME MEASURES: A questionary was filled out for all participants with their age, how many hours had spent since sexual intercourse took place (within 24 h), usual method of contraception used, previous use of EC, level of education, and reason for this request. RESULTS: 89 women. Drops out: 0. Average age: 23.7+/-48 years (range: 16-40 years). 79.8% of them came to medical emergency services in less than 24 h after sexual intercourse. Usual anticonceptive method was the condom (88.8%), 2.2% used hormones, 9% no contraceptive method at all and none of them had used the intrauterine device. 34.8% were previous users of EC. Education levels: 2.2% of women only could read and write, elementary school (37.1%), secondary school (34.8%) and high school (25.8%). Reasons for requesting EC: 91% condom failure, 7.9% not to have used any contraceptive method, and 1.1% wrong use of natural birth control methods. Among the women who had went to the emergency services within the 24 h of the sexual intercourse the 77.4% of all of them had requested EC previously and the 93% of those had requested EC for the first time (P=.032). Likewise all of them with high school level and who could write and read, the 93.9% with elementary school level, and the 71% with secondary studies went to the emergency services within the 24 h of the non protected sexual intercourse (P=.05). CONCLUSIONS: Most of the women were young, they perceived the unprotected sexual intercourses as an emergency, the condom was the most frequently used anticonceptive method, they requested EC due to condom breakage. In 1/3 of the cases the EC had been requested previously and this group and the young women with secondary studies one were who requested it later.

Adolescent↗