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PubMed1991

Oral contraceptives and antithrombin III: variations by dosage and ABO blood group.

A randomized clinical trial of oral contraceptives evaluated 67 women on a regimen of 50 micrograms ethinyl estradiol and 1.0 mg norethindrone, 61 women on a regimen of 35 micrograms ethinyl estradiol and 1.0 mg norethindrone, and 64 women on a regimen of 35 micrograms ethinyl estradiol and 0.5 mg norethindrone. ABO blood group type was determined in all women. At baseline and at 3, 6, and 9 months, plasma antithrombin III levels, by both an immunologic and an activity method, and selected plasma levels of the contraceptive steroids were measured. Antithrombin III levels for all oral contraceptive groups combined decreased from baseline by 19.7% and 28.8% for the immunologic and activity methods, respectively. Analysis of interrelationships among antithrombin III by activity method, oral contraceptive type, and ABO blood group showed larger declines in antithrombin III for type O women using the highest estrogen dose preparation (31.6%) and for non-type O women using the lowest progestin dose preparation (38.9%). Plasma levels of contraceptive steroids also were related to changes in the most extreme levels of antithrombin III.

ABO Blood-Group System↗
PubMed1987

Norplant contraceptive implants: rods versus capsules.

Norplant contraceptive implants are silastic implants containing levonorgestrel. When placed subcutaneously in the medial aspect of the upper arm, they release low levels of levonorgestrel in a constant manner over an extended period of time. Comparative studies of two silastic rods versus six capsules containing levonorgestrel were studied in 250 subjects for 4,464 months of use. Only one pregnancy occurred during the study. Side effect patterns were similar in both groups; the major side effect being irregular uterine bleeding. The bleeding, however, was well tolerated by subjects in both groups and discontinuation rate was very low. The two-rod system offers the advantages of easier insertion technique and shorter insertion time as well as ease of removal as compared to the six-capsule system. Norplant contraceptive implants offer a highly effective means of contraception which is particularly suited for women who are concerned about failure and compliance with oral contraceptives. This type of contraception should become well accepted, not only in underdeveloped countries, but in developed countries as well.

Adolescent↗
PubMed1994

Coagulation and anticoagulation effects of contraceptive steroids.

Epidemiologic data support the notion that first-generation high-dose oral contraceptives (containing > 80 micrograms of estrogen) increased the incidence of thromboembolic events. The quantitative interpretation of these data is difficult because results were often confounded by life-style factors and inadequate diagnostic procedures. With the introduction of modern low-dose combination oral contraceptives, the incidence of thromboembolic events decreased markedly. Although all combined oral contraceptives induce statistically significant changes in hemostatic factors, these changes are generally within normal ranges, and their clinical significance is questionable. Overall, increased activity in hemostatic mechanisms appears to remain in balance. Progestin-only formulations seem to affect hemostatic parameters to a much lesser degree, and their use has not led to an increased risk of thrombosis. Interindividual variations in pharmacokinetics and pharmacodynamics of contraceptive steroids are great and could tentatively explain why certain persons may be at an increased risk of thrombosis. Although most studies have looked at steady-state conditions during contraceptive steroid intake, it would seem prudent to investigate further the hemostatic system during a non-steady-state condition, such as that occurring during the first few days of the pill-free interval.

Blood Coagulation↗
PubMed1990

The effects of different formulations of oral contraceptive agents on lipid and carbohydrate metabolism.

BACKGROUND: Oral contraceptives can induce changes in lipid and carbohydrate metabolism similar to those associated with an increased risk of coronary heart disease, including increased serum triglyceride, low-density lipoprotein (LDL) cholesterol, and insulin levels and decreased high-density lipoprotein (HDL) cholesterol levels. In this study, we examined whether modification of the type or dose of progestin in oral-contraceptive preparations diminishes these changes. METHODS: We measured plasma lipoprotein levels and performed oral glucose-tolerance tests in a cross section of 1060 women who took one of nine types of oral contraceptives for at least three months and 418 women who took none. Seven of the contraceptive formulations contained various doses and types of progestin: levonorgestrel in low (150 micrograms), high (250 micrograms), and triphasic (50 to 125 micrograms) doses; norethindrone in low (500 micrograms), high (1000 micrograms), and triphasic (500 to 1000 micrograms) doses; and a new progestin, desogestrel, in one dose (150 micrograms). All seven contained 30 to 40 micrograms of ethinyl estradiol. Two additional formulations contained progestin alone. RESULTS: As compared with controls, women taking combination drugs did not have increased serum total cholesterol levels but did have increases of 13 to 75 percent in fasting triglyceride levels. Levels of LDL cholesterol were reduced by 14 percent in women taking the combination containing desogestrel and by 12 percent in those taking low-dose norethindrone. Levels of HDL cholesterol were lowered by 5 percent and 16 percent by the combinations containing low-dose and high-dose levonorgestrel, respectively; these decreases were due to reductions of 29 percent and 43 percent, respectively, in the levels of HDL subclass 2. The combination pill containing high-dose norethindrone did not affect HDL cholesterol levels, whereas that containing low-dose norethindrone increased HDL cholesterol levels by 10 percent. The desogestrel combination increased HDL cholesterol levels by 12 percent. Levels of apolipoproteins A-I, A-II, and B were generally increased by combination drugs. Depending on the dose and type of progestin, combination drugs were associated with plasma glucose levels on the glucose-tolerance test that were 43 to 61 percent higher than in controls, insulin responses 12 to 40 percent higher, and C-peptide responses 18 to 45 percent higher. Progestin-only formulations had only minor metabolic effects. CONCLUSIONS: The appropriate dose and type of progestin may reduce the adverse effects of oral contraceptives on many metabolic markers of risk for coronary heart disease. Progestin-only formulations or combinations containing desogestrel or low-dose norethindrone were associated wtih the most favorable profiles.

Adolescent↗
PubMed1992

Contraception after thirty-five.

Our knowledge about the safety, the incidence of side effects, and the effectiveness of contraceptive methods for women in premenopause, or during the last decade of their reproductive life, has not been a primary interest for research and development in fertility control. The main purpose of trials for the evaluation of new contraceptive methods is to test their effectiveness, and therefore only women below 38 years of age are accepted. Furthermore, when new methods are being tested, only healthy women are accepted, and those having health problems of almost any kind are excluded. Therefore our knowledge about the contraceptive methods in women over 40 years of age is scanty and comes from trials with a long-lasting follow-up on healthy women who can use the method without problems until they are 45 or reach menopause. We have very limited reported information on the use of contraceptives by women who have cardiovascular disease, diabetes, liver problems, etc. Therefore the main body of experience in this review comes from healthy women between 35 and 44. On the other hand, one should remember that these women have a high motivation to use contraceptive methods and therefore the continuation rate in the trials is high. This compensates for the relatively small number of acceptors by giving more women-years in follow-up. Continuation rate and the proper use of methods are directly correlated to increase in age, socioeconomical status, and to education of users. Highly educated women in this age group have very low failure rate with almost any method.

Adult↗
PubMed1982

Long acting injectable hormonal contraceptives.

Injectable hormonal preparations can be highly effective and satisfactory contraceptives. The two main preparations available today are depot medroxy progesterone acetate (DMPA) and norethisterone oenanthate (NET-OEN), but several other approaches are currently under clinical trial. Injectable contraceptives have some unique advantages which give them justifiably wide appeal amongst many groups of women. However, they do have a number of disadvantages including invariable menstrual disturbance and a delay in the return of fertility. One formulation of DMPA, Depo-Provera, is probably the most extensively investigated single hormonal contraceptive ever made. These studies indicate that it is remarkably safe and does not face any more unresolved issues than the combined pill, intrauterine device or tubal sterilization. However, for a number of disparate emotional and political reasons it has attracted the attention of several consumer and feminist groups, who have waged a prolonged and quite unjustified campaign against it. It is to be hoped that future debate will be conducted on a more informed, rational and less emotional basis. Injectable contraceptives should have an important place in the family planning armamentarium of all countries, and current developments should lead to a decrease in concerns about presently available agents. This should further increase the widespread acceptability of this approach to contraception.

Animals↗
PubMed2004

Steroid hormones for contraception in men.

BACKGROUND: Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so "add-back" therapy is needed. OBJECTIVES: To summarize all randomized controlled trials of male hormonal contraception. SEARCH STRATEGY: We searched the computerized databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Popline, and LILACS (each from inception to February, 2003) for randomized controlled trials of hormonal contraception in men. We wrote to authors of identified trials to seek unpublished or published trials that we might have missed. SELECTION CRITERIA: We included all randomized controlled trials in any language that compared a steroid hormone with another contraceptive. We excluded non-steroidal male contraceptives, such as gossypol. We included both placebo and active-regimen control groups. All trials identified included only healthy men with normal semen analyses. DATA COLLECTION AND ANALYSIS: Azoospermia (absence of spermatozoa on semen examination) was the primary outcome measure. Data were insufficient to examine pregnancy rates and side effects. MAIN RESULTS: The proportion of men who achieved azoospermia varied widely in reports to date. Few significant differences emerged from these trials. Levonorgestrel implants combined with injectable testosterone enanthate (100 mg IM) was significantly more effective than was levonorgestrel 125 mcg by mouth daily combined with testosterone patches (10 mg/d) (OR for azoospermia with the oral levonorgestrel regimen 0.03; 95%CI 0.00-0.29). The addition of levonorgestrel 500 mcg by mouth daily improved the effectiveness of testosterone enanthate 100 mg IM weekly by itself (OR for azoospermia with the combined regimen 4.0; 95%CI 1.00-15.99). Several regimens, including testosterone alone and GnRH agonists and antagonists, had disappointing results. REVIEWERS' CONCLUSIONS: No male hormonal contraceptive is ready for clinical use. All trials published to date have been small exploratory studies. As a result, their power to detect important differences has been limited and their results imprecise. In addition, the definition of oligospermia has been imprecise or inconsistent in many reports. To avoid bias, future trials need more attention to the methodological requirements for randomized controlled trials. Trials with adequate power would also be helpful.

Contraception↗
PubMed1990

Reduction of the risk of rheumatoid arthritis among women who take oral contraceptives.

Discrepant results among investigations of the association between oral contraceptive use and rheumatoid arthritis (RA) have been ascribed to shortcomings in the study methods. In the present study, we obtained detailed information on oral contraceptive use in 135 young women with confirmed definite or classic RA of recent onset and in 378 controls with soft tissue rheumatism or osteoarthritis. All patients had at least 2 years of followup to confirm the consistency of the diagnosis. Oral contraceptive use at any time before disease onset was reported by 70% of the RA patients and 85% of the controls; the latter figure corresponded to general population data for The Netherlands. This yielded a relative risk for RA of 0.39 among those who had ever used oral contraceptives and 0.58 for those using oral contraceptives at the time of symptom onset. The preventive effect of oral contraceptive use on the risk of RA was found to be independent of the dose, duration of use, or presence of HLA-DR4. The strongest protection was seen in women with a family history of RA and in women ages 31-40 at symptom onset. The conflicting results in the literature are discussed, and a possible biologic mechanism for this phenomenon is suggested.

Adult↗
PubMed1990

Contraceptive steroids as a risk factor for hepatocellular carcinoma: a case/control study in South African black women.

The role of contraceptive steroids in the etiology or pathogenesis of hepatocellular carcinoma in urban South African black women was investigated in a hospital-based case and control study. Participating were 46 women, 19 to 54 yr old, with carcinoma, and 92 matched controls. South African blacks have a high incidence of hepatocellular carcinoma, and urban black women have used contraceptive steroids fairly widely for a number of years. Use of contraceptive steroids for longer than 6 mo (mean duration 46.7 mo) was not found to pose a risk for development of hepatocellular carcinoma in this population--relative risk 0.8 (95% confidence interval [C.I.] 0.4 to 1.7). This was also true of use for longer than 8 yr--relative risk 0.6 (95% C.I. 0.2 to 2.5), and if a combination of an estrogen and a progestogen or a progestogen alone was used (relative risk 1.7 [95% C.I. 0.7 to 4.2] and 0.4 [95% C.I. 0.1 to 1.2], respectively). Chronic hepatitis B virus infection was confirmed to have an etiological association with hepatocellular carcinoma, but there was no evidence that contraceptive steroids acted as a co-carcinogen with the virus or, conversely, that they played a causal role in patients negative for hepatitis B surface antigenemia. We cannot, however, exclude the possibility that contraceptive steroids may play a causal role in hepatocellular carcinoma in black women who have never been infected with the hepatitis B virus. Nor was there evidence that contraceptive steroids acted in concert with either cigarette smoking or chronic alcohol abuse in hepatocarcinogenesis.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

Oral contraceptives and cervical neoplasia.

Although initial studies examining the relationship of oral contraceptives to risk of cervical neoplasia were reassuring, more recent studies provide some evidence of a positive relationship, particularly for long-term usage. Results, however, are difficult to interpret, because of a variety of methodologic complexities, including potential sources of confounding and bias. Sexual behavior and Pap smear screening have been identified as important confounders, but in several well-controlled studies residual excess risks of nearly 2-fold persist for users of 5 or more years. A possible promotional effect of oral contraceptives is suggested by higher risks associated with recent usage. There also is some suggestion of a stronger effect for adenocarcinomas than for squamous cell tumors. A relationship is biologically possible, given findings of hormone receptors in cervical tissue and the fact that oral contraceptives have been found to induce cervical hyperplasia. In addition, oral contraceptives may induce proliferation of the human papillomaviruses, the leading suspect agent for cervical cancer. Although a number of lines of evidence support a relationship of oral contraceptives to cervical cancer risk, firm conclusions await the results of additional studies that specifically address some of the methodologic shortcomings of previous investigations. In particular, additional follow-up studies are needed to define the effect of oral contraceptives on the natural history of cervical lesions.

Adenocarcinoma↗
PubMed1993

Oral contraceptives and the dexamethasone suppression test.

Among other confounding factors, the influence of the intake of estrogen-containing oral contraceptives on the dexamethasone suppression test (DST) results has never been specifically studied. Therefore, we performed 1 mg DSTs in 14 healthy women taking oral contraceptives and 14 age-matched women taking no oral contraceptives. Mean 0800h basal total cortisol was significantly higher among the women taking contraceptives than in the control group, whereas mean free cortisol did not significantly differ. At 1600h following DST, no significant difference existed between the two groups. Two subjects taking contraceptives and one control subject were considered DST nonsuppressors. These results confirm the powerful influence of oral contraceptives on basal total cortisol levels but suggest a lack of significant influence on DST results.

Adult↗
PubMed1992

Oral contraceptive use and cervical intraepithelial neoplasia.

To explore the somewhat controversial relationship between oral contraceptives and pre-invasive cervical cancer, 103 cases of biopsy-confirmed cervical intraepithelial neoplasia (CIN) II or CIN III were compared with 258 controls who had normal cervical cytology. Cases were slightly less likely than controls to have ever used oral contraceptives; the odds ratio, controlling for age, socioeconomic status, barrier method use, smoking history, age at first sexual intercourse, number of sex partners, current marital status, and number of Pap smears, was 0.7 (95% CI 0.3-1.6). Recency, latency, duration, and age at first oral contraceptive use were evaluated and in no instance was oral contraceptive use positively associated with CIN. This study adds to the body of knowledge that oral contraceptives are not associated with pre-invasive cervical cancer. Further, if oral contraceptive users continue to be regularly screened, their risk of developing the more invasive lesions should be very low.

Adolescent↗
PubMed2005

Beyond the pill: new data and options in hormonal and intrauterine contraception.

With the goal of helping clinicians facilitate contraceptive success for their patients, this Clinical Opinion provides an update regarding older hormonal and intrauterine contraceptives and details newer methods that include the progestin-releasing intrauterine system, the contraceptive patch and ring, and extended and emergency oral contraception. Last, I will look over the horizon and briefly describe potential future methods that include the single rod progestin-releasing implant, folic acid-supplemented oral contraceptives, and hormonal contraception for men.

Contraception↗
PubMed1992

Epidemiology of the noncontraceptive effects of oral contraceptives.

Epidemiologic studies have made major contributions to our understanding of oral contraceptive safety. The findings of major studies of the risk of cardiovascular disease and neoplasia associated with oral contraceptive use are reviewed, with discussion of the many factors to be considered in the interpretation of conflicting results. Mortality data that were based on earlier oral contraceptive formulations, dosage, and usage patterns may not be relevant to current practices. Recent studies suggest that reduced doses of estrogens and progestins in current oral contraceptive formulations and better screening of patients have reduced the risks of cardiovascular disease associated with oral contraceptive use, with the most important exception being an increased risk among older women who smoke. While most epidemiologic studies demonstrate no overall association between oral contraceptives and breast cancer, unanswered questions remain concerning this relationship.

Cardiovascular Diseases↗
PubMed1999

Oral contraceptives and smoking, current considerations: recommendations of a consensus panel.

In a closed meeting, members of the consensus panel evaluated the presentations of the scientific panel and developed a series of recommendations. They outlined clinical imperatives related to the identification and education of patients who smoke, the physician's role in smoking cessation, and the prescription of oral contraceptives for patients who smoke. They also outlined research objectives for the future. The most important suggestions include the following: All patients should be asked about their smoking status at every visit, and all smokers should be encouraged and helped to quit. The decision to prescribe an oral contraceptive requires a detailed personal and family history of thrombotic disease. Measurement of lipid profile should be considered, along with exercise and dietary intervention, for smokers >35 years old who use or request oral contraceptives. Patients >35 years old who smoke heavily (>15 cigarettes/d) should be denied the use of oral contraceptives. Preliminary data suggest that an oral contraceptive with the very low dose of 20 micrograms ethinyl estradiol may be safer for oral contraceptive users who smoke, even for those >35 years old who have an occasional cigarette, but these laboratory findings require clinical corroboration.

Cardiovascular Diseases↗
PubMed1996

A comparison of contraceptive habits and pregnancy outcome at 19 years of age in two cohorts of Swedish women born 1962 and 1972.

The prevalence of contraception and pregnancy outcome in two representative samples of 19-year-old women resident in the city of Göteborg, born in 1962 (n = 596) and 1972 (n = 641), respectively, was assessed and compared using a postal questionnaire technique. The prevalence of different contraceptive techniques was as follows (62/72): Oral contraception (OC) alone 44%/35%, (p < 0.001); OC + condom 1%/12%, p < 0.001; intrauterine device 4%/1%, p < 0.001; condom only 11%/14%; depot gestagen 0%/0.3%; no contraception 40%/38%. The median duration of OC use was 15 and 14 months, respectively. Fear of OCs was the commonest reason given for cessation of OC in the 62 cohort and that contraception was no longer required in the 72 cohort. The proportion of women who gave the latter explanation for cessation of OC had increased (p < 0.001) from 10% in 1981 to 57% in 1991, indicating that young women in Sweden now tend not to continue with OCs when a relationship ends. Although the prevalence of cigarette smoking was reduced (p < 0.05 in the 72 cohort compared to the 62 cohort), there was still an over-representation of smokers in both cohorts among contraceptive users (p < 0.001) and in women who had been pregnant (p < 0.001) or undergone an abortion (p < 0.001). Pregnancies were reported by 11% of the women from the 62 cohort and by 13% from the 72 cohort. A greater proportion (p < 0.001) of pregnancies terminated in legal abortion in the 72 cohort (61%) compared to the 62 cohort (50%). The medical complication rate following legal abortion was lower (p < 0.05) in the 72 cohort compared to the 62 cohort.

Abortion, Legal↗
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↗
PubMed1998

The contraceptive self-efficacy scale: analysis in four samples.

Previous research has established a relationship between contraceptive self-efficacy (CSE), as measured by the 18-item CSE scale, and young women's contraceptive behavior. In this paper, the authors continue to explore the scale and its relationship to contraceptive behavior with four diverse samples to establish generalizability and to set guidelines for use of the scale. A series of correlational analyses were conducted with each sample. A pattern of low correlations among CSE items across samples emerged, indicating that use of the total item set separately as the basis for CSE was warranted. Zero-order and partial correlations revealed which CSE items were correlated with contraceptive behavior as well as which items explained unique variance in contraceptive behavior for each sample. Regression analyses showed that CSE was significantly predictive of contraceptive behavior for all samples. These results are discussed in terms of scale properties and use in research and clinical settings. Educational implications are formulated as well.

Americas↗