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PubMed1995

The frameless GyneFix intrauterine implant: a major improvement in efficacy, expulsion and tolerance.

The CuFix (GyneFix), conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 woman years of experience and up to 8 years of follow-up in international multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. Based on new clinical information about the GyneFix from a long-term multicenter clinical trial, conducted in young nulligravid/nulliparous and parous women, the importance of this new contraceptive is discussed. The following conclusions were reached: The unique design characteristics of the GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. The GyneFix reduces the IUD failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. Framelessness and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. The GyneFix is a promising new, highly effective and safe, contraceptive option for parous women and an equally effective and well-accepted method for nulliparous women.

Adolescent↗
PubMed2001

Optimization of contraceptive dosage regimen of Centchroman.

Centchroman (Ormeloxifene), a non-steroidal oral contraceptive, is used at a dose of 30 mg once a week. To prevent failures in the beginning of the therapy, it is recommended that a dose of 30 mg twice a week for 12 weeks be administered to build up adequate blood levels. The present study was undertaken to simplify the dosing schedule without sacrificing the purpose of twice a week dosing regimen, using modeling and measurement approaches. The drug was given to 60 female volunteers who were divided into seven groups: group I, 30 mg weekly; group II, 30 mg twice a week; group III, 30 mg twice a week for 12 weeks followed by 30 mg weekly; group IV, 30 mg twice a week for 6 weeks followed by 30 mg weekly; group V, 60 mg weekly; and groups VI and VII, single 60 mg loading dose followed by 30 mg weekly doses. The blood samples were collected and analyzed by HPLC. In group I, mean trough concentrations of centchroman and its active metabolite, 7-desmethyl centchroman, were comparable to the steady-state trough concentrations in groups III, IV, VI, and VII. The metabolite to parent drug ratio remained constant in all the groups. The pharmacokinetic parameters in group VII were comparable to those reported after a single 30 mg dose. Dosage regimen VI was more convenient and provided better pregnancy protection (Pearl index 1.18; unpublished report) than regimen III, which is currently on the market and, thus, could be effectively used for contraception.

Centchroman↗
PubMed1994

Contraception for patients with psychiatric or medical disorders.

The increased risk that pregnancy carries for women with medical disorders must be weighed against the risks of reversible contraception. In the absence of prospective randomized trials of various contraceptive methods and their effect on a given disease process, the clinician must use information regarding the risk of pregnancy in a woman with medical problems, the well-documented failure rates of various methods, and the probability that the patient will use the method (or any other method) effectively. The possible effects of contraceptive methods on cardiovascular, endocrinologic, neurologic, and other medical disorders are discussed as are appropriate contraceptive options and considerations for these women.

Cardiovascular Diseases↗
PubMed1980

[Is today's condom better than its reputation?].

In a statistical sample of 500 unwanted pregnancies surprisingly the share of women whose partners used a condom was not higher than the share of IUP-users (considering the relative frequency of use of both methods). This result was the motivation to investigate once more the use of the condom. After a short description of the history, the production, and the testing methods a discussion follows of the frequency of its use. In many countries the frequency of using the condom lies between that of hormonal oral contraceptives and the IUP. Today the reliability of the condom is higher than described in medical textbooks. In statistics of the seventies the failure rate is no more than 3 unwanted pregnancies in 100 years of usage. Harmful side effects or contraindications are not known. Therefore in cases of incompatibility or refusion of hormonal oral contraceptives reflections of the doctor on useful alternative methods of contraception should include the recommendation of the condom.

Contraceptive Devices, Male↗
PubMed1995

The economic value of contraception: a comparison of 15 methods.

OBJECTIVES: The purpose of the study was to determine the clinical and economic impact of alternative contraceptive methods. METHODS: Direct medical costs (method use, side effects, and unintended pregnancies) associated with 15 contraceptive methods were modeled from the perspectives of a private payer and a publicly funded program. Cost data were drawn from a national claims database and MediCal. The main outcome measures included 1-year and 5-year costs and number of pregnancies avoided compared with use of no contraceptive method. RESULTS: All 15 contraceptives were more effective and less costly than no method. Over 5 years, the copper-T IUD, vasectomy, the contraceptive implant, and the injectable contraceptive were the most cost-effective, saving $14,122, $13,899, $13,813, and $13,373, respectively, and preventing approximately the same number of pregnancies (4.2) per person. Because of their high failure rates, barrier methods, spermicides, withdrawal, and periodic abstinence were costly but still saved from $8933 to $12,239 over 5 years. Oral contraceptives fell between these groups, costing $1784 over 5 years, saving $12,879, and preventing 4.1 pregnancies. CONCLUSIONS: Contraceptives save health care resources by preventing unintended pregnancies. Up-front acquisition costs are inaccurate predictors of the total economic costs of competing contraceptive methods.

Contraception↗
PubMed1996

[Intrauterine copper contraceptive implants].

GyneFix, conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 women years of experience and up to 8 years of follow-up in international, multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. The following conclusions were reached: 1. The unique design characteristics of GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. GyneFix reduces the IUD-failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. 2. Frameless and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. 3. Insertion of GyneFix, with or without local anaesthesia, is easily accomplished in the office of a few minutes. Removal is easy, quick and painless. 4. GyneFix is an equally effective and well accepted method fro nulliparous women.

Equipment Design↗
PubMed2006

Emergency contraception: knowledge and perceptions in a university population.

PURPOSE: The purpose of this study was to examine knowledge, attitudes, and behaviors regarding emergency contraception (EC) in university men and women aged 18-21. DATA SOURCES: Data sources included responses to a 25-item questionnaire and an 8-item demographic survey completed anonymously at a public site on campus. Ninety-seven university students participated in the study. Participants were asked to respond to questions relating to knowledge, attitudes, and behaviors regarding EC, perceived worthiness, objections, sources of information about EC, preferred birth-control method and usage, and perceptions of their personal risk of unintended pregnancy. CONCLUSIONS: Many respondents considered unintended pregnancy to be a major problem and considered EC a worthy option in the event of method failure or unprotected intercourse. While most participants were aware that there was a postcoital method of contraception, confusion existed between EC and RU-486 (the abortion pill). Almost half (49.5%) believed that EC was the same as RU-486. There was an association between advanced prescription for EC and its likelihood of use. Most women would be significantly more likely to use EC if they had a prescription on hand. Of the women who were less likely to choose EC, 100% indicated they would feel embarrassed or judged when asking for it. Only 34% of those women who have had a gynecological exam in the past 12 months had discussed EC with their provider. IMPLICATIONS FOR PRACTICE: Advanced practice nurses need to incorporate EC into preventive health counseling for both men and women. Providing women with an advanced prescription increases the likelihood that women will use EC.

Adolescent↗
PubMed1985

Systemic lupus erythematosus, renal disease, hemodialysis and vitamin A.

Recent studies indicate that clinically-active systemic lupus erythematosus (SLE) is uncommon in patients with end-stage renal disease undergoing long-term hemodialysis. Several lines of indirect evidence suggest that the dialysis procedure itself may be responsible for inducing remission; that SLE could reflect a toxicity reaction to excessive tissue levels of vitamin A; and that remission associated with dialysis may be due to a gradual reduction in vitamin A levels at the sites of SLE activity.

Contraceptives, Oral↗
PubMed1997

Characterization of corrosion products on a copper-containing intrauterine device during storage at room temperature.

This paper studies the characterization of corrosion products formed on corroded and uncorroded copper-containing intrauterine devices stored at room temperature for a period of 30 months. The experimental techniques used were X-ray photo-electron spectroscopy and Auger electron spectroscopy. The compounds found were cuprite (Cu2O) and tenorite (CuO). The latter was the main compound formed on corroded samples, forming thin tarnish films.

Copper↗
PubMed2004

Contraceptive risk and compensatory behaviour in young people in education post-16 years: a cross-sectional study.

OBJECTIVES: To describe contraceptive risk and compensatory behaviour, using condoms or emergency contraception (EC), in young people in education aged 16-24 years. DESIGN: Cross-sectional study. SUBJECTS: A total of 1135 students aged 16-24 years. SETTING: Educational establishments in and around London, UK. RESULTS: Seventy-six percent of women and 55% of men reported having experienced sex either without contraception or when a condom split or came off. Most participants (or their sexual partners) who reported such risks had compensated by using EC at least once (72% women, 55% men) but only a minority had compensated on each occasion of risk (37% women and 22% men). Of the oral contraceptives users the majority (83%) had experienced a pill 'problem' and the majority of these participants had compensated for such problems by using condoms (79%). Fewer than half of the women who experienced pill problems (45%) compensated by using condoms on each occasion. Less than a quarter (23%) of those who experienced pill problems but did not compensate by using condoms ever compensated by using EC. CONCLUSIONS: This study demonstrates high levels of primary contraceptive risk and low levels of consistent compensatory condom or EC use. The findings suggest that there would be large increases in EC use and repeated use if all primary contraceptive risks were followed by compensatory action. Interventions to increase contraceptive use should focus not only on initiation of contraception use but acknowledge that risks do happen and promote both continuing use and compensatory behaviour.

Adolescent↗
PubMed2002

Pilot study of short-term acceptability and breakage and slippage rates for the loose-fitting polyurethane male condom eZ.on bi-directional: a randomized cross-over trial.

OBJECTIVE: To assess the short-term acceptability and functionality of the eZ.on condom compared with currently marketed latex (Gossamer) and polyurethane (Avanti) condoms. Method Healthy, sexually active volunteers aged 18-50 years, self-selected from among the UK population, were enrolled in a randomized cross-over trial. Participants were required to test six of each of three condom variants. Data were collected on structured questionnaires by means of postal and telephone contacts. Main outcome measures were breakage and slippage rates, and short-term user acceptability based on participants' ratings documented in end-of-study questionnaires. RESULTS: Forty-three couples entered the study, of whom 37 tested the condoms on 512 occasions. There was no statistically significant difference in the clinical breakage rate between eZ.on (3.7%) and the comparator condoms (3.5% for Gossamer and 2.9% for Avanti). Complete slippage rates were similar for eZ.on (2.4%) and Avanti (2.9%). Gossamer had the lowest slippage rate (1.2%), but this difference was not statistically significant. User acceptability was similar for the three condom types; however, there was a trend for more participants to express dissatisfaction with eZ.on, including difficulties with putting on the condom. CONCLUSIONS: No firm conclusions can be drawn from this pilot study, but our observations suggest that eZ.on may be an acceptable option for some couples unwilling or unable to use a latex condom.

Adult↗
PubMed1973

Low dosage progestagen as an oral contraceptive: a clinical study.

A low dose of an oral progestagen (norethindrone 0.35 mg. daily) was used as a contraceptive agent in a group of 70 women. The average period of use was 16.7 months; it was over two years in 21 subjects. Eight patients withdrew from the trial because of excessive or irregular bleeding. The incidence of side effects was lower than with the combined type of contraceptive preparations. Of the six pregnancies that occurred, only two could be attributed to failure of the method.

Adult↗
PubMedDate not supplied

[Classification of oral contraceptives and its practical application to choice of prescriptions].

The authors have tried to classify the oral contraceptives at present in use throughout the world by their respective levels of oestrogenic and progestogenic components, taking into consideration also the relative strength of each product in use. They have based this classification on their personal experience of the several oral contraceptive products and on a profound study of the international literature. In this way it is possible to define a place for each oral contraceptive so that it can be chosen for the best possible use of a particular product for the hormonal background of the person using the contraceptive. It is true that changes have to be made to work out the oral contraceptives used for masses of people, but on the other hand in countries where there is sufficient medical personnel and education so that it is possible to think out and to prescribe for an individual, it seems to us useful that the doctor who is prescribing should try to adjust the oral contraceptive to the hormonal climate of the woman seeking it. This is true not only for the first time a prescription is made but in cases where by the accident of failure to tolerate the product something must be done to correct the troubles that are so often found in the first months after starting to use contraceptive products. This study includes a general picture of all oral contraceptives in which the products have been classified according to the total dose of oestrogens administered and according to the proportions of progesterone to oestrogens which make up the hormonal climate of the product. On the other hand this study also includes a list of the observations to make in order to adapt the oral contraceptive to the side-effects shown after the first prescription. The authors have come to the conclusion that by adapting the choice of a particular oral contraceptive to the woman who is to receive it interruptions in taking the contraceptive because of side-effects should be avoided. So unwanted pregnancies will be avoided and also the termination of these unwanted pregnancies.

Contraceptives, Oral↗
PubMed1986

[Modern aspects of contraception].

As the ideal contraceptive has not been found after a quarter century of global contraception research, this is an attempt to assess the advantages and drawbacks of the so-called "safe" methods of contraception currently in use. The most persuasive arguments in favour of oral contraceptives which other reversible methods cannot claim are their unsurpassed safety as well as the simplicity of their application. The disadvantage of potential damages through the perennial intake of hormones can be minimized with the low dosages of modern compounds. Recommendations are made concerning the controlled use of the various kinds of ovulation-inhibitors. Likewise, the use of ovulation-inhibitors with adolescents, at the end of reproductive age, and with women afflicted with diabetes mellitus are discussed. Advantages and drawbacks of contraception through the exclusive use of progestagen are briefly stated. Despite good applicability in single cases, intrauterine contraception should rather be viewed as a second choice only. Yet the standard problems, such as menstrual disturbances, increased tendency toward inflammations and individual incompatibility remain unsolved. Moreover, the rate of failure of 3% is ten times as high as with the ovulation-inhibitors. In their instructions some producers recommend too short a period of placement of the device in the uterus. Most IUD's can stay in place for a longer period of time. Repeated references to the possible complications of the use of IUD's with nulliparous women are made. As an emergency method to prevent a pregnancy after intercourse without contraceptives a hormonal method as well as the post-coital insertion of an IUD are discussed. After completed family planning the definitive sterilization presents itself as the ideal method of contraception, either through tubal sterilization in case of the woman, or vasectomy in case of the man. Rates of complications, failure rates, and chances of reversibility of both methods are specified.

Austria↗
PubMed2006

Mutagenesis as an unbiased approach to identify novel contraceptive targets.

To accommodate diverse personal needs in family planning, diverse contraceptive approaches are desirable. This goal requires identification of new contraceptive targets. Phenotype-driven mutagenesis is an unbiased approach to identify novel genes and functions in reproductive processes. The ReproGenomics Program at The Jackson Laboratory is a United States National Institutes of Health resource for production, identification and distribution of mutant mouse models of infertility that can be used for identification of potential targets for contraception. The strategy of this program is whole genome, random ENU mutagenesis, coupled with a phenotype screen for breeding failure as the only phenotype. A three-generation breeding scheme selects recessive mutations affecting reproductive functions. G3 males and females that fail to reproduce by natural mating to wild-type animals undergo secondary phenotype screens to assess gonad and accessory organ histology, hormone production, gamete production and gamete function in fertilization. The genetic transmission of the infertility trait in each family is confirmed and each mutation is genetically mapped to a defined chromosome region, facilitating identification of candidate genes from sequence and expression databases. Genes essential for fertility in both males and females and acting both meiotically and post-meiotically have been identified by this strategy. Phenotypes include male infertility with normal sperm count, but failure in fertilization of oocytes. Phenotype descriptions of each mutation are posted on the program website, . These unique reproductive mutant mouse resources will lead to new discoveries in andrology (and gynecology) research, as well as reproductive medicine. Dissection of gene function in known and newly discovered reproductive pathways will expand our focus to reveal novel targets for contraception.

Alkylating Agents↗
PubMed1988

Breast cancer in relation to early use of oral contraceptives. No evidence of a latent effect.

A long-term effect of oral contraceptives (OCs) on breast cancer risk has been suggested as an explanation for some studies' failure to detect an association between OCs and breast cancer. To address this latency hypothesis, we analyzed data on 4714 case subjects and 4540 control subjects from the population-based Cancer and Steroid Hormone Study. No support was evident for a latent effect of OCs on breast cancer risk through age 54 years: among parous women who had cumulated more than six years of OC use before their first term pregnancy, the risk of breast cancer, relative to nonusers before first term pregnancy, was 0.6 at zero to four years after first term pregnancy (95% confidence interval [Cl], 0.2 to 1.8), 0.7 at five to nine years (95% Cl, 0.3 to 1.7), and 1.1 at ten to 14 years (95% Cl, 0.3 to 3.9). Among nulliparous women with more than six years of OC use in total, the relative risk of breast cancer, by interval from last use of OCs, was 1.3 at zero to four years (95% Cl, 0.8 to 2.0), 1.1 at five to nine years (95% Cl, 0.5 to 2.0), and 0.6 at ten to 14 years (95% Cl, 0.1 to 3.7).

Adult↗
PubMed1993

Safety and efficacy of a triphasic oral contraceptive containing desogestrel: results of three multicenter trials.

This report combines the data obtained in three multicenter efficacy studies with a new triphasic oral contraceptive combination containing desogestrel (DSG) and ethinyl estradiol (EE). The studies were conducted at 40 investigational sites in the United States (38 centers) and Canada (2 centers) in support of the FDA approval of the product. In total, 1,095 subjects were exposed to the study medication for 11,231 cycles, corresponding to approximately 864 woman-years of use. Of these subjects, 414 completed at least 13 cycles of treatment. Contraceptive efficacy was high; six pregnancies occurred during the in-treatment period (two due to method failure and four due to user failure), corresponding to Pearl Indices of 0.23 and 0.46, respectively. The incidence of irregular bleeding was low, and the acceptability was excellent as evidenced by the low incidence of drug-related drop-outs. No drug-related serious adverse experiences were reported, and the incidence of other drug-related adverse experiences was generally low and decreased with continued use. No effects were seen on blood pressure, body mass index, laboratory parameters, cervical cytology and breast nodularity. These studies demonstrate that triphasic DSG/EE is an effective and acceptable triphasic oral contraceptive preparation with excellent cycle control and no significant physiologic effects.

Adolescent↗