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PubMed1975

Oral conception and uterine size-ultrasonic study.

The effect of oral contraceptives on uterine size has been examined by B-mode ultrasonography. The subjects were 39 women (mean age 21) with regular menstrual cycles. None of them had taken the pill previously. The combined pill (E-con or Neo-Primovlar) was prescribed for 21 and the progestogen-only pill (Exluton) for 18 of the participants. The uterine size was measured with the help of B-scanning prior to the pill and after it was taken for three and six months. All three ultrasound examinations were carried out on the same day of the cycle plus or minus one day). No difference can be observed between the three measurements of uterine size either in the women on the combined pills or those on th progestogen-only pill (p greater than 0.05). The study will be continued. So far six women have been examined by ultrasound after having taken oral contraceptives for 12 months. Uterine size has remained unchanged in each case.

Adolescent↗
PubMed1998

Levonorgestrel capsule implants in the United States: a 5-year study.

OBJECTIVE: To measure effectiveness, adverse event experience, and acceptability of the Food and Drug Administration-approved variant of levonorgestrel capsule implants in the United States through 5 years and to examine determinants of these outcomes. METHODS: In a prospective, multicenter study, 511 sexually active women selecting contraceptive implants were monitored four times in the 1st year, then semiannually through 5 years. Adverse events were elicited by query and physical examination, and their incidence was measured. Lifetable analyses computed pregnancy and other discontinuation rates. Cox regression models examined effects of age, parity, and preadmission desire for more children on continuation. Removal times were analyzed by analysis of variance. RESULTS: Three pregnancies occurred, yielding a 5-year cumulative rate of 1.3+/-0.8 per 100 users, an average annual rate of three per 1000 women, and an ectopic pregnancy rate of 0.6 per 1000 woman years. No pregnancies occurred to women weighing less than 79 kg. Prolonged or irregular menstrual bleeding, followed distantly by headache, weight gain, and mood changes, was the most frequent medical conditions leading to removal. Weight gain averaged 1 kg per year. Each annual continuation rate was above 80 per 100, for a cumulative 5-year rate of 39 per 100. Continuation was age-dependent, with younger women (younger than 25 years at entry) having lower 5-year continuation rates than older subjects (P < .01). Tissue trauma from deeply placed or poorly aligned implants or severe reactions to local anesthetic affected subjects in 3.1% of removals (nine cases). CONCLUSION: As measured by annual continuation rates of 80 per 100 or higher and annual pregnancy rates below one per 100, implant contraception in the United States was found to be highly acceptable and effective, year after year, regardless of the woman's age or family formation status. The cumulative 5-year pregnancy rate, 1.3 per 100, is comparable to that of tubal ligation.

Adult↗
PubMed1983

Plasma lipids in women using progestogen-only oral contraceptives.

Using a strict protocol, in an attempt to avoid confounding factors, healthy women were assigned at random to a continuous daily dose of either 30 micrograms levonorgestrel or 350 micrograms norethisterone. Volunteers were either aged 40-45 years, or were less than 30 years and 8-12 weeks post partum. Blood plasma lipids and lipoproteins were measured on specimens collected in the fasting state before treatment, then every month during progestogen treatment. After 6 months there was a small increase in plasma triglycerides, especially in older women, and also in a non-lactating younger group. Changes in lipoprotein-cholesterol fractions were insignificant, though there were significant pretreatment differences between the various groups.

Adult↗
PubMed1998

A chronic, low-dose regimen of the antiprogestin ZK 137 316 prevents pregnancy in rhesus monkeys.

Continual administration of low doses of the antiprogestin ZK 137 316 was previously reported to permit ovarian/menstrual cyclicity, but disrupt endometrial growth in macaques. The contraceptive efficacy of this regimen was tested in female rhesus monkeys (10 per group) treated daily with vehicle (controls), 0.01 or 0.03 mg ZK 137 316 per kg body weight for 30 days before and during continual co-habitation with males of proven fertility. Treatment continued until confirmation of pregnancy or for 5 months after pair-housing with males. Mating and vaginal sperm were evident in all females. A cumulative pregnancy rate of 90% (9/10) was observed in the controls. Of the 10 animals receiving 0.01 mg/kg, four conceived during the first 2 months of pairing (P = 0.06) with no further conceptions. No pregnancies were observed in the 0.03 mg/kg group (P < 0.01). Timely, overt menses occurred at a higher frequency in the 0.01 mg/kg group than the 0.03 mg/kg group. However, corpora lutea were present in ovaries from both groups during the last treatment cycle, indicating that ovarian cycles occurred. Thus, chronic administration of low-dose ZK 137 316 that permits continued ovarian cyclicity and a high incidence of timely menses, prevents pregnancy in non-human primates. This regimen may provide a novel method of contraception for women.

Animals↗
PubMed1995

Oral contraceptive side effects: where's the beef?

The initial report is reviewed, as well as the results of subsequent investigations, and the current status of the following side effects attributed to the use of oral contraceptives: subjective symptoms such as mood and libido changes, also headache; melanoma; gallbladder disease; liver tumors, sickle cell disease exacerbation; teratogenesis; "post-Pill" amenorrhea; atherogenesis; and diminished carbohydrate tolerance. In many instances a cause-and-effect relationship appears to be incorrect or highly improbable. In other instances the side effects are clinically insignificant or so rare as to be of minimal importance. Yet they continue to be listed by various authorities as validated side effects or relative contraindications to oral contraceptive use. This, in turn, limits the access of many women to a highly effective form of contraception. This re-examination of past history is intended to modernize our concepts of the safety of this modality.

Contraceptives, Oral↗
PubMed2003

Factors associated with oral contraceptive discontinuation in rural Bangladesh.

Oral contraceptives (OCs) account for half of all modern contraceptive methods used in Bangladesh, however, discontinuation remains fairly high in OC use. This paper identifies factors associated with discontinuation of OC use, where discontinuation refers to cessation of OC use in the 6 months prior to the survey. The data for this study were drawn from a survey on OC compliance in rural Bangladesh. A total of 1600 OC users, current or past, aged 15 to 49 years were interviewed; of these, 36% discontinued OC use. Of the women who discontinued, 47% reported the experience of side-effects as the main reason for OC discontinuation. Multivariate analysis identified lack of fieldworker's visit as the strongest predictor of OC discontinuation; women who were not visited by fieldworkers had a four-fold risk of discontinuing OC use. Discontinuation of OC use decreased with increased duration of use and number of living children. OC discontinuation was associated with side-effect experiences, lack of husband's support in OC use and failure to purchase OCs. Of great concern is that about 70% of the women who were at risk of unintended pregnancy were not using any method of contraception following OC discontinuation. Husband's education was positively associated with the substitution of OCs with another contraceptive method. Effective OC use should be advocated through adequate counselling about how to take it correctly, the possibility of side-effects and their proper management and, more importantly, the possible alternative contraceptive method should OCs prove unsatisfactory or unsuitable. Better provider-client interactions along with improved access to the newly established community clinics could be instrumental in the continued and effective use of OCs.

Adolescent↗
PubMed1997

Oral contraception and venous thromboembolism. A New Zealand perspective.

Several recent case control studies have shown an excess rate of venous thromboembolism in women using third generation progestogen-containing combined contraceptive pills compared to second generation combined contraceptive pills. This excess is about 1 in 10,000 women per year of use. It is likely that second and third generation pills have been preferentially prescribed to users who have varying susceptibility to venous thromboembolism and that this may account for at least part of the observed differences. In practice, it is essential that all women using combined oral contraceptive pills have a thorough history taken to exclude any contraindications or risk factors. Each client should be counselled about the risks and benefits of oral contraception. In New Zealand, the Ministry of Health has recommended that prescribers for women starting a contraceptive pill for the first time should consider a pill that does not contain a third generation progestogen. Women already receiving a third generation pill may elect to continue that pill after the differential rates of venous thromboembolism have been discussed.

Bias↗
PubMed2002

Male contraception.

The provision of safe, effective contraception has been revolutionized in the past 40 yr following the development of synthetic steroids and the demonstration that administration of combinations of sex steroids can be used to suppress ovulation and, subsequently, other reproductive functions. This review addresses the current standing of male contraception, long the poor relation in family planning but currently enjoying a resurgence in both scientific and political interest as it is recognized that men have a larger role to play in the regulation of fertility, whether seen in geopolitical or individual terms. Condoms and vasectomy continue to be popular at particular phases of the reproductive lifespan and in certain cultures. Although not perfect contraceptives, condoms have the additional advantage of offering protection from sexually transmitted infection. The hormonal approach may have acquired the critical mass needed to make the transition from academic research to pharmaceutical development. Greatly increased understanding of male reproductive function, partly stimulated by interest in ageing and the potential benefits of androgen replacement, is opening up other avenues for investigation taking advantage of nonhormonal regulatory pathways specific to spermatogenesis and the reproductive tract.

Condoms↗
PubMed1996

Provision of emergency contraception by nurses: a way forward to increased access.

OBJECTIVES: The objectives of the study were to assess the suitability of a service for provision of emergency hormonal contraception by nurses. METHODS: Retrospective analysis was carried out of data obtained from the case records of 500 consecutive women who attended ABACUS (a city center-based family planning clinic in Liverpool, UK) for emergency contraception during the 7th and 9th months of the first year (1994) of the service. Similar data were collected for 100 consecutive women during 1 month of the third year (June 1996). The number of women who received emergency hormonal contraception was noted. In particular, details pertaining to the reasons for referral to the doctor and the trend of referrals were noted. RESULTS: The results indicate that during the first year the nurses independently issued emergency hormonal contraception to 37% of the women. They referred the remaining 63% to the medical staff. One-third of referrals were for ongoing contraception, especially oral contraception. Another third of referrals appeared to be due to 'nurse anxiety', as no medical or other cause was found for these referrals. During the third year, nurses dispensed emergency hormonal contraception to 64% of women. Among the remaining 36% of women who were referred to the doctor, 19% needed hormonal contraception. Referral reflecting 'nurse anxiety' significantly declined (1%) compared to the first year of service. CONCLUSIONS: Ongoing contraception, particularly initiation of oral contraception, was one of the main reasons for referral during the first year. Referral due to 'nurse anxiety' significantly declined with continued experience and may have reflected initial anxiety and the learning curve. With increased experience over the first 2 years, the outcome of this service showed encouraging improvement. The nurses now dispense emergency hormonal contraception to a majority of women.

Adolescent↗
PubMed2002

Continuity of women's work, breastfeeding, and fertility in Ghana in the 1980s.

Much of the inconsistency that has appeared in studies of the effect of women's work on fertility in less developed countries has been attributed to the varying accessibility of employment in the modern sector. The analysis presented in this paper shows that continuity of work matters more than sector of work. It also confirms that, even in a setting of low contraceptive prevalence, increased fecundity associated with the less intense breastfeeding practices of working women do not result in shorter birth intervals. The influence of women's work on fertility control is likely to be underestimated if the effects of sporadic versus continuous work are conflated, or if fecundity differentials by work status are unmeasured.

Breast Feeding↗
PubMed1996

New hormonal methods of contraception.

Three types of new contraceptive delivery system have been discussed in this chapter. Each have novel methods of delivery and may be acceptable to certain groups of women. It is clear that subdermal contraceptive implants are extremely useful as a long-term method of contraception, and provided insertion occurs correctly, removal will then be easy. The second-generation implants using a single rod, compared with the first-generation ones using six capsules, would appear to offer advantages both to the patient and in relation to the training of medical and paramedical personnel who have to fit the subdermal implant. The main disadvantage is the incidence of irregular bleeding, which, by and large, can be overcome by pre-insertion counselling and by time. The second method of delivery, vaginal rings, offers high patient acceptability, but a usable ring for contraception has as yet to be developed. Two approaches appear to be the use of a continuous progestogen-only ring, or a combined ring releasing oestrogen and progestogen with a 21-day-in, 7-day-out cycle of use. Ongoing studies will indicate whether vaginal lesions are significant or related to the flexibility of the ring. If these studies prove satisfactory, further development of the vaginal rings, both as an alternative method for interval use or as a specific postpartum form of contraception using progesterone-releasing rings, will be developed. Significant developments in the use of a combined monthly injectable have led to the release of two preparations, Cyclofem and Mesigyna, which are now available in many countries. This combined approach offers a significant reduction in amenorrhoea rates and unacceptable bleeding, the majority of women having acceptable menstrual patterns even during the first 3 months of use. All three methods have low and acceptable rates of pregnancy, the lowest being seen with the subdermal implants and with combined monthly injectables. Due to the length of action of subdermal implants, these may find a niche for women wishing to use a long-acting method and not wishing to be sterilized. They also provide a useful method where medical intervention is not available on a regular basis. Monthly injectable preparations can be given by paramedical personnel, and introductory studies have indicated that in developing and developed countries, they are highly acceptable. All three methods offer an increased choice for women and safe and effective methods of contraception.

Administration, Intravaginal↗
PubMed2001

Assessing the acceptability, service delivery requirements, and use-effectiveness of the diaphragm in Colombia, Philippines, and Turkey.

The diaphragm is not available in many countries, despite the recommendations of numerous authors that it has important advantages as a woman-controlled method that offers some protection against sexually transmitted diseases, and one that is safe and free of side effects. An interagency team collaborated to introduce the diaphragm in Colombia, the Philippines, and Turkey, using the same protocol to assess the acceptability, service delivery requirements and use-effectiveness of the method. Eighteen public and private sector service delivery sites were involved and a total of 550 women were enrolled in the study. Provider training aimed to improve the quality of care with which all methods were delivered and included counseling about sexuality and reproductive health risks. The cumulative 12-month pregnancy rate of 10.1 (SE 1.7) per 100 woman-years is on the low end of previous studies of the diaphragm, and the 12-month continuation rate (57.2 [SE 2.4] per 100) compares favorably with that for oral contraceptives and the intrauterine device. Focus group discussions conducted with clients and providers indicated that the method was an important alternative for some women, particularly those who had experienced health problems with other methods or were unable to negotiate condom use with their partners. Provider biases diminished as they observed the strategic niche that the diaphragm filled for their clients. While providing the diaphragm requires training and good client-provider interaction, the requirements are consistent with those called for in the Programme of Action of the International Conference on Population and Development (ICPD, 1994). With proper attention to quality of care, the diaphragm can be successfully offered in resource-poor settings.

Adolescent↗
PubMed2000

Safety and effectiveness of vasectomy.

OBJECTIVE: To recommend further research on vasectomy based on a systematic review of the effectiveness and safety of vasectomy. DESIGN: A systematic MEDLINE review of the literature on the safety and effectiveness of vasectomy between 1964 and 1998. MAIN OUTCOME MEASURE(S): Early failure rates are <1%; however, effectiveness and complications vary with experience of surgeons and surgical technique. Early complications, including hematoma, infection, sperm granulomas, epididymitis-orchitis, and congestive epididymitis, occur in 1%-6% of men undergoing vasectomy. Incidence of epididymal pain is poorly documented. Animal and human data indicate that vasectomy does not increase atherosclerosis and that increases in circulating immune complexes after vasectomy are transient in men with vasectomies. The weight of the evidence regarding prostate and testicular cancer suggests that men with vasectomy are not at increased risk of these cancers. CONCLUSION(S): Publications to date continue to support the conclusion that vasectomy is a highly effective form of contraception. Future studies should include evaluations of the long-term effectiveness of vasectomy, evaluating criteria for postvasectomy discontinuation of alternative contraception for use in settings where semen analysis is not practical, and characterizing complications including chronic epididymal pain syndrome.

Adolescent↗
PubMedDate not supplied

New OTC drugs and devices 2003: a selective review.

OBJECTIVES: To present current information about trends development and marketing of over-the-counter (OTC) medications and dietary supplement products and describe new products, delivery systems, home monitoring devices, and home accessories in these markets that are likely generating questions from or posing potential problems for patients. DATA SOURCES: Recently published clinical and pharmaceutical industry literature. STUDY SELECTION: By the authors. DATA EXTRACTION: By the authors. DATA SYNTHESIS: Last year witnessed the first effort of the Food and Drug Administration (FDA) to remove a dietary supplement from the U.S. market. Ephedra, because of its imminent danger when used for weight reduction and athletic enhancement, was the target of FDA action. FDA has issued a final rule implementing this ban, which prohibits the sale of dietary supplements containing ephedrine alkaloids (e.g., ephedra). Two newer diet-aid products are being actively promoted with little or no safety and effectiveness data. Thus, pharmacist's vigilance is important along with sensible advice on how to lose weight safely and effectively. Further, two independent organizations have created certification programs for dietary supplements that ensure product purity, active ingredient strength, and compliance with good manufacturing practices. In addition, through recent changes in federal legislation, consumers are now able to obtain reimbursement for their nonprescription purchases through flexible spending accounts. Information is presented in this article about selected products in these OTC, home care, and dietary supplement categories: heartburn (proton pump inhibitors), allergy (second-generation antihistamines), constipation (laxatives), diabetes mellitus (blood glucose monitoring systems), home testing (fertility monitoring), nicotine addiction (smoking cessation products), otic disorders (ear syringes), contraceptives and sexual aids (condoms and lubricants), and dermatology (wart removal). CONCLUSION: Patients continue to increase their reliance on self-care. To assist them, pharmacists must remain up-to-date on trends and have an understanding of the nuances of consumers' behavior and thinking in relation to OTC products and their use.

Drug Labeling↗
PubMed2005

Motion sickness susceptibility fluctuates through the menstrual cycle.

INTRODUCTION: Surveys of transportation by sea, land, and air indicate that women are more susceptible to motion sickness than men, showing higher incidences of vomiting and reporting more symptoms such as nausea. The cause of this greater motion sickness susceptibility in women is unknown. One suggestion is that it is due to the functioning of the female endocrine system, but there are contradictions between existing studies. HYPOTHESIS: Motion sickness in women varies across the menstrual cycle. METHODS: There were 12 healthy women, age 24.4 +/- 6.6 yr (mean +/- SD), not using contraceptive medication, who were exposed to a provocative cross-coupled (Coriolis) motion continued to the point of moderate nausea. The motion stimulus was whole body rotation on a turntable, during which subjects executed head tilts of approximately 45 degrees in batches of eight spaced at 30-s intervals during a staircase profile of rotational velocity which commenced from stationary and incremented in steps of 3 degrees x s(-1) every 30 s. Subjects were tested on: A.) day 5 'menstruation'; B.) day 12 'ovulatory'; C.) day 19 'mid-luteal'; and D.) day 26 'pre-menstrual,' according to a design counter-balanced for order. RESULTS: Mean +/- SD sequences of head movements required to achieve moderate nausea were: A.) 13.7 +/- 2.8; B.) 14.3 +/- 4.5; C.) 15.4 +/- 6.6; and D.) 16.9 +/- 6.1. The difference between A and D was significant (p < 0.05, 2-tailed). CONCLUSIONS: There was a trend indicating that motion sickness susceptibility was maximal at day 5 'menstruation', decreasing through days 12 and 19 to a minimum at day 26 'pre-menstrual', to a small but significant extent. However, it is unlikely that this can fully account for the greater susceptibility in women since the magnitude of fluctuation in susceptibility across the cycle is only around one-third of the overall difference between male and female susceptibility.

Adolescent↗
PubMed1983

Free thyroxin by radioimmunoassay: evaluation of a new direct method involving a radiolabeled thyroxin analog.

We present here the first performance evaluation of a new direct method for free thyroxin (T4) in serum by radioimmunoassay, with use of coated tubes and a radiolabeled T4 analog (Diagnostic Products Corp.). The assay is precise and robust: within-run imprecision (CV), 3.1-6.6%; between-run imprecision, 4.0-7.9%; no demonstrable variation between technologists irrespective of experience with the method. No outliers were observed when we compared the free T4 results with serum total T4. Reference values are reported for a total of 1243 euthyroid subjects; there was no significant age effect on serum free T4 in women 26 to 72 years old. The biological variation was about +/- 35% of the mean (2 SD). Free T4 results are the same for serum and plasma. The assay performs well in hypothyroidism and hyperthyroidism, and distinguishes individuals with thyroid disease from normal individuals. Free T4 values in women taking oral contraceptives are normal. Depressed results were often observed in acute nonthyroidal illness and continuing pregnancy. These results were directly comparable with those of another commercial direct radiolabeled-T4 analog kit for free T4.

Adult↗
PubMed1998

Depot medroxyprogesterone acetate (Depo-Provera) and levonorgestrel (Norplant) use in adolescents among clinicians in Northern Europe and the United States.

PURPOSE: To compare attitudes and practices related to clinicians' use of depot medroxyprogesterone acetate [Depo-Provera (DMPA)] and levonorgestrel implants in adolescents in three northern European countries and the United States. METHODS: Between the fall of 1993 and the winter of 1995, surveys eliciting clinician attitudes and practices with the two contraceptive methods were collected from practitioners who provide contraceptive care to teens in Sweden (n = 282), The Netherlands (n = 197), Great Britain (n = 108), and the United States (n = 548). RESULTS: Clinicians in Great Britain and the United States reported prescribing of DMPA, selected DMPA in their top three choices for contraception in teens, and had patients ask about DMPA more frequently than clinicians in Sweden or The Netherlands (p < 0.0001). U.S. clinicians were more likely to report prescribing of the implants, list them as a top choice, and have patients ask for it more frequently than were providers in the other three countries (p < 0.0001). Noncompliance with previous contraceptives was the most common indication for use of either method in this age group. "Worst fears" with DMPA use included infertility, particularly among Swedish clinicians (p < 0.0001), as was pregnancy and loss to follow-up, particularly among British clinicians (p < 0.0001). Condom nonuse was a concern associated with both methods. Breakthrough uterine bleeding was a concern related to implant use, particularly among Swedish practitioners (p < 0.0001). CONCLUSION: Clinicians in the United States and Great Britain display more enthusiasm toward the use of the long-term progestins in adolescents than do clinicians in Sweden or The Netherlands. Continuing education programs could be designed to educate clinicians to allay their concerns about these contraceptives in countries where teen pregnancy is considered a problem.

Adolescent↗
PubMed2000

Length of use and symptoms associated with premature removal of the levonorgestrel intrauterine system: a nation-wide study of 17,360 users.

OBJECTIVE: To establish the continuation rates of the levonorgestrel intrauterine system (LNG IUS) and symptoms associated with its premature removal. SAMPLE AND SETTING: All women in Finland who had a LNG IUS inserted between April 1990 and December 1993 and whose doctor had filled in and returned a form at the insertion visit. This study population consists of 46% of all the LNG IUSs sold in Finland between 1990 and 1993. DESIGN: A questionnaire on reproductive and contraceptive history, gynaecological problems and symptoms experienced during the use of the LNG IUS was sent to 23,885 LNG IUS users. A total of 17,914 questionnaires were returned (response rate 75%). The results cover experience from 58,600 woman years. A log-rank-test was used to test differences in continuation rates. Multivariate analyse were performed using Cox's proportional hazard model. RESULTS: The LNG IUS was prematurely removed from 5175 women. The one, two, three, four and five year continuation rates were 93%, 87%, 81%, 75% and 65%, respectively. The symptoms during the use of the LNG IUS most strongly associated with its premature removal were excessive bleeding and spotting, and infections and pain. The risk of premature removal was markedly lower among women who had occasional or total absence of menstruation. Premature removal was less likely in the oldest age group. CONCLUSIONS: The continuation rate of the LNG IUS compares favourably with other long-acting contraceptive systems. Totally or occasionally absent menstruation was strongly associated with prolonged continuation.

Adult↗