The effect of two low-dose oral contraceptives and non-hormonal contraception on serum lipids and high-density lipoprotein cholesterol.
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Biology↗
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Impact of accessibility of contraceptives on contraceptive prevalence in Guatemala.
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Adolescent↗
Oral contraceptives, venous thrombosis, and varicose veins. Royal College of General Practitioners' Oral Contraception Study.
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Adolescent↗
A quest for better contraception: the Ford Foundation's contribution to reproductive science and contraceptive development 1959-1983.
This review describes the Ford Foundation's program of support of research and training in reproductive science and contraceptive development from 1959 through 1983. An appraisal of some of the merits and limitations of that program and of its impact on the field is also presented.
Academies and Institutes↗
Indian Council of Medical Research. Task Force on Hormonal Contraception: Phase II randomized clinical trial with norethisterone oenanthate 50 mg alone and in combination with 5 mg or 2.5 mg of either estradiol valerate or cypionate as a monthly injectable contraceptive.
A Phase II multicentric study was carried out to compare the different contraceptive treatment schedules of the monthly injectable consisting of norethisterone oenanthate (NET OEN) 50 mg either given alone or in combination with estrogen esters, 2.5 or 5 mg of estradiol valerate (E2 Val.) or estradiol cypionate (E2 Cyp.). A total of 364 women were observed for 1686 months of use. Analysis of the bleeding pattern data indicated that NET OEN 50 mg when given alone gave rise to delayed cycles and/or amenorrhoea. However, the addition of estrogen esters in a dose of either 2.5 or 5 mg provided significantly better bleeding patterns. Of the different treatment schedules investigated, the combination of NET OEN 50 mg with E2 Val. 5 mg provided more consistent and better cycle control. These findings however need further validation on a larger study sample.
Adult↗
A randomized double-blind study of the effects of two low-dose combined oral contraceptives on biochemical aspects. Report from a seven-centred study. WHO Special Programme of Research, Development and Research Training in Human Reproduction. Task force on Oral Contraceptives.
A comparative study of the metabolic effects of two combined oral contraceptive preparations was undertaken in seven WHO Collaborating Centres for Research in Human Reproduction. A total of 847 subjects were randomly allocated to one of two pill groups - norethisterone lmg/ethinyl estradiol 35 micrograms (NET/EE) or levonorgestrel 150 micrograms/ethinyl estradiol 30 micrograms (LNG/EE). An additional 195 women using an IUD served as a comparison group. Blood samples were taken on admission, and at 3 and 12 months thereafter. Both pills induced changes in fasting and 2-hour glucose, triglycerides, total cholesterol, HDL-cholesterol, bilirubin, alkaline phosphatase, albumin, and total protein, but not aspartate aminotransferase. The most dramatic and probably most clinically important changes were an increase in triglycerides and a decrease in HDL-cholesterol. The NET/EE preparation appeared to induce a greater increase in triglycerides, but no significant difference was found between the two pill preparations with respect to HDL-cholesterol changes.
Adult↗
A multicentre comparative study of serum lipids and lipoproteins in four groups of oral combined contraceptive users and a control group of IUD users. World Health Organization. Task Force on Oral Contraceptives.
A prospective clinical trial was conducted in three centres to assess the effects of the type and dose of progestogen, the dose of estrogen and the progestogen-to-estrogen ratio of oral contraceptives on lipid metabolism. The preparations selected contained levonorgestrel 250 micrograms + ethinyl estradiol 50 micrograms (Neogynon), levonorgestrel 250 micrograms + ethinyl estradiol 30 micrograms (Eugynon 30), levonorgestrel 150 micrograms + ethinyl estradiol 30 micrograms (Microgynon) or norethisterone acetate 1 mg + ethinyl estradiol 50 micrograms (Minovlar). Four-hundred-and-seven premenopausal women were randomly assigned to one of the four pill groups and compared to a control group of 119 users of a CuT220c intrauterine device. Total cholesterol, HDL-cholesterol, LDL-cholesterol and total triglycerides were monitored and the analysis includes the data of those who were followed over 48 weeks, 241 OC users and 87 IUD users. 250 micrograms of levonorgestrel were found to induce more unfavourable lipid changes in terms of atherosclerotic risk than 1mg of norethisterone acetate. Levonorgestrel was found to have a dose-effect on HDL-cholesterol and LDL-cholesterol serum levels, while ethinyl estradiol had a dose-effect on serum triglycerides. HDL-cholesterol was related to the progestogen-to-estrogen ratio. Most of these findings were consistent across centres. Finally, some comments are made on the implications of the study results on the design of future lipid studies.
Adolescent↗
A multicentre phase III comparative study of two hormonal contraceptive preparations NET-OEN (50 mg) + E2 valerate (5 mg) given every month and NET-OEN (200 mg) given every 2 months as intramuscular injection--a report of 12-month study. Indian Council of Medical Research Task Force on Hormonal Contraception.
A phase III randomized clinical trial was undertaken to compare the efficacy, side effects and acceptability of a combined monthly injectable preparation containing NET-oenanthate (NET-OEN) (50 mg) plus oestradiol valerate (E2 Val.) (5 mg) with NET-OEN only (200 mg) given every two months. A total of 849 subjects were observed for 7817 woman-months of contraceptive use. Net discontinuation rates due to involuntary pregnancy at 12 months were 0.2 and 1.1 per 100 users for one monthly and two monthly injectable preparations, respectively. Although the monthly preparation was found to be efficacious and the subjects using the monthly preparation had a better bleeding pattern, the net discontinuation rate at 12 months due to menstrual disturbances did not show any significant difference between the two preparations. With proper counselling and motivational strategies, it is likely that acceptability of monthly injectables can be further enhanced.
Adolescent↗
Serum lipid variations in women on copper intrauterine devices, triphasic oral contraceptives and monthly injectable contraceptives.
This is a longitudinal, prospective, comparative controlled study. Patient selection excluded smokers, overweighed, hypertensive, and aged greater than 34 years. 168 women were distributed by random list into four groups: A) fitted with inert IUD (control); B) with Nova T (Cu-IUD); C) received triphasic gestodene (OC); and D) monthly norethisterone enanthate 50 mg + estradiol valerate 5 mg (injectable). Serum lipid patterns were assessed at the beginning of contraceptive use and at 1, 6 and 12 months. The results of the Cu-IUD group did not show any difference with the control group. The OC group showed an increase of HDL and a significant lowering of LDL cholesterol at 6 months but this reverted by 12 months. On the other hand, in the injectable group, a sharp decrease of total lipids, total cholesterol and LDL was observed from the first month, lasting throughout 12 months, yielding significant difference with controls and also with pre-treatment values. In sum, the monthly injectable showed quite favorable patterns that would deserve further study, especially in view of the scarcity of hitherto available information concerning this formulation.
Adult↗
Teaching contraception: an interactive presentation using managing contraception.
OBJECTIVE: Our purpose was to determine whether an interactive medical student contraceptive teaching session results in improved knowledge gain or satisfaction when compared with a standard, didactic lecture. STUDY DESIGN: An interactive lecture was compared with a standard lecture among third-year medical students at Oregon Health and Science University School of Medicine and Medical College of Georgia. Knowledge gain was assessed by comparing correct responses to a posttest with the students' own responses to the same questions given as a pretest before the lecture. Satisfaction with the lecture was assessed on a visual analog scale. Scores and satisfaction ratings were compared within and between lecture groups. RESULTS: A total of 150 students participated. There was a significant increase in test scores within both the interactive and standard groups ( P < .0001 for both groups). The change in scores did not differ significantly between the groups ( P = .087). Although overall satisfaction was significantly greater with the standard lecture ( P = .004), it was high with both lectures. CONCLUSION: Knowledge gain with the interactive lecture was equivalent to that with the standard lecture. Satisfaction with both learning formats was high.
Adult↗
Effective use of hormonal contraceptives: Part I: Combined oral contraceptive pills.
This systematic review examines evidence regarding when during the menstrual cycle a woman can initiate combined oral contraceptive (COC) use and what can be done if a woman misses COCs. We searched the MEDLINE and EMBASE databases for articles published from 1966 to March 2005 related to COC initiation and to the effects of late or missed COCs. We identified 11 studies related to COC initiation and 25 studies related to the effects of missed pills. Evidence from these studies suggested that taking hormonally active pills for 7 consecutive days prevents normal ovulation and that initiating COCs through Day 5 of the menstrual cycle suppresses follicular activity. Studies on the effects of missed COCs generally showed that the risk of ovulation is greatest when the pill-free interval lasts >7 days. Limitations of this body of evidence include small sample sizes that may not reflect variation in larger populations, lack of a standard measurement of ovulation and difficulty in discerning how ovulation resulting from late or missed COCs corresponds to the risk of conception.
Contraceptives, Oral, Combined↗
Thromboembolic stroke in young women. A European case-control study on oral contraceptives. Transnational Research Group on Oral Contraceptives and the Health of Young Women.
A matched case-control study was performed between 1993 and 1996 in 16 centers in the United Kingdom, Germany, France, Switzerland, and Austria. The objective was to determine the influence of oral contraceptives (OC), particularly those containing modern progestins, on the risk for ischemic stroke in women aged 16-44 years. A total of 220 women who had had an incident ischemic stroke and were compared with 775 control subjects who were unaffected by stroke. At least one hospital and one community control subject per patient was matched and interviewed with the corresponding patient for 5-year age band and for area of residence. Crude odds ratios (95% confidence intervals [CI]) for ischemic stroke were as follows. For current use of any OC versus no use 2.3 (1.7-3.2), the adjusted odds ratio (OR) 3.6 (2.4-5.4). The OC associated risk was higher for first generation than for second or third generation OC. The risk estimates for patients versus community control subjects were always lower than for hospital control subjects. No major regional difference of the risk estimates was found. Compared with nonusers of OC without hypertension, women with hypertension who used OC had an almost 10-fold increased risk. However, OC users who had had a blood pressure check before OC prescription had a lower risk than did those without such a check. Smoking > 10 cigarettes/day is associated with higher risk of stroke, particularly for OC users. No significant effect was found for duration of OC use. We conclude that although there is a small relative risk of occlusive stroke for healthy women currently using OC, the attributable risk is very small because the incidence in this age group is very low. The small increase in risk of OC use may be further reduced by preventive efforts for cardiovascular risk factors, particularly hypertension and smoking.
Adolescent↗
Contraceptive efficacy and safety of a monophasic oral contraceptive containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol: United States clinical experience using a "Sunday start" approach.
OBJECTIVE: To report on experience in the United States with a monophasic oral contraceptive (OC) containing 150 micrograms desogestrel and 30 micrograms ethinyl E2 (EE). The results of a multicenter evaluation of efficacy, cycle control, and safety over 6 months of exposure using a "Sunday start" regimen is evaluated. SETTING: Multicenter. DESIGN: Open noncomparative study. PARTICIPANTS: Study subjects were a mean age of 25 years, and the majority were educated, nonobese, white, nulliparous, and previously had used OCs. INTERVENTIONS: A total of 809 women were exposed to study medication for a total of 4,096 cycles (equivalent to 341.3 women-years of use). RESULTS: Efficacy was excellent. One user-failure pregnancy occurred (Pearl index 0.32); there were no method-failure pregnancies. Study medication was well tolerated; 6.6% of the subjects discontinued treatment because of drug-related adverse events. The study medication exhibited no adverse effects on blood pressure, body weight, or laboratory variables. Cycle control was evaluated in 697 subjects. In a total of 3,640 cycles, the incidences of intermenstrual bleeding, breakthrough bleeding, breakthrough spotting, and absence of withdrawal bleeding were 9.8%, 1.7%, 8.1%, and 1.4%, respectively, indicating appropriate cycle control. Patient acceptability was high; seven subjects (1%) discontinued the study because of menstrual irregularity (metrorrhagia). CONCLUSION: The results of this study, comparable to those demonstrated in a recent European multicenter study, add further documentation to the published data on the safety, efficacy, cycle control, and acceptability of this monophasic desogestrel-containing combined OC using a "Sunday start" approach.
Adolescent↗
Oral contraceptive use and malignancies of the genital tract. Results from the Royal College of General Practitioners' Oral Contraception Study.
Of 47,000 women followed since 1968, those who had used oral contraceptives (ever-users) had a significantly higher incidence rate of cervical cancer than never-users. After standardisation of rates by age, parity, smoking, social class, number of previously normal cervical smears, and history of sexually transmitted disease, the excess was 41 per 100,000 woman-years for carcinoma-in-situ and 8 per 100,000 woman-years for invasive cervical cancer. Incidence increased with increasing duration of use: the standardised incidence rate for cervical cancer in women who had taken the pill for more than 10 years was four times than in never-users. Ever-users had a lower incidence of other uterine cancers (deficit 5 per 100,000 woman-years); a lower incidence of ovarian cancer was also found (deficit 4 per 100,000), but was not statistically significant. Overall, ever-users had an excess incidence for genital tract cancers 37 per 100,000 woman-years. This excess was mainly from carcinoma-in-situ of the cervix; the excess incidence of invasive cervical cancer was offset by the deficits in other uterine and ovarian cancers. Standardised mortality rates from genital cancer were similar in ever-users and never-users. Of relevance to clinical practice is the substantially different distribution of primary cancer sites: cervical cancer accounted for 75% of the invasive genital cancers and 74% of deaths from genital cancer in ever-users, but only 31% of the invasive cancers and 30% of deaths in never-users.
Adolescent↗
Oral contraceptives and risk of breast cancer in women aged 20-54 years. Netherlands Oral Contraceptives and Breast Cancer Study Group.
Although the use of oral contraceptives (OCs) is not generally associated with increased risk of breast cancer, higher risks have been reported for some subgroups of users. We have carried out a population-based case-control study in the Netherlands to assess the effect of timing and duration of OC use on the risk of breast cancer developing at various ages. 918 women with breast cancer (20-54 years at diagnosis) were pair-matched by age with controls randomly selected from municipal registries. Information on OC use obtained from women and their prescribers was combined according to standard decision rules. Overall, long-term use of OCs (> or = 12 years) had an associated relative risk (RR) of 1.3 (95% CI 0.9-1.9; test for trend in risk with months of use p = 0.03). This positive trend was found in both the youngest (< 36 years; p = 0.08) and the oldest (46-54 years, p = 0.004) age groups, but not in women aged 36-45 years. The RR of developing breast cancer before age 36 was 2.1 (1.0-4.5) for 4 or more years of OC use compared with shorter use. In women younger than 36, risk increased for longer OC use before age 20 (1.44 per year, p = 0.04). Recent use (previous 3 years) was associated with increased risk in women of 46-54 (RR 1.9 [0.9-4.1], p = 0.02). We conclude that 4 or more years of OC use, especially if partly before age 20, is associated with an increased risk of breast cancer developing at an early age. There is limited evidence that the excess risk disappears as the cohort of young OC users ages, but this issue needs confirmation.
Adult↗
Oral contraceptives and venous thrombosis: different sensitivities to activated protein C in women using second- and third-generation oral contraceptives.
Epidemiological studies have shown that women who use third-generation oral contraceptives (OC) containing desogestrel, gestodene or norgestimate have a higher risk of venous thrombosis than women who use second-generation OC containing levonorgestrel. It is also known that a mutation in factor V (factor V(Leiden)), which results in resistance to activated protein C (APC) and which is the most common cause of hereditary thrombophilia, potentiates the prothrombotic effect of OC. Effects of APC on thrombin generation in the plasma of women using OC were compared to the response to APC in non-OC users and in individuals that were heterozygous or homozygous for factor V(Leiden). The response towards APC was evaluated on basis of the ratio (APC-sr) of the time integrals of thrombin formation determined in the presence and absence of APC. Compared with women not using OC, women who used OC exhibited a significantly decreased sensitivity to APC (P<0.001), independent of the kind of OC used. Women who used third-generation monophasic OC were significantly less sensitive to APC than women using second-generation OC (P<0.001) and had APC-sr that did not significantly differ from heterozygous female carriers of factor V(Leiden) who did not use OC. Women who were heterozygous for factor V(Leiden) and used OC had APC-sr in the range of homozygous carriers of factor V(Leiden). Two women who started OC therapy had significantly elevated APC-sr within 3 d. Acquired APC resistance may explain the epidemiological observation of increased risk for venous thrombosis in OC users, especially in women using third-generation OC.
Adolescent↗
A multicentre study of coagulation and haemostatic variables during oral contraception: variations with geographical location and ethnicity. Task Force on Oral Contraceptives--WHO Special Programme of Research, Development and Research Training in Human Reproduction.
A comparative study of the effects of combined oral contraceptives (OC) on coagulation and fibrinolytic variables using standardized laboratory technique and methodology has been performed in Dublin (Ireland), Salvador (Brazil), Santiago (Chile) and Singapore. Of 777 entrants to the study, 622 were randomly allocated to receive one of four different OC formulations. The remainder did not opt for OC. The progestogenic component was levonorgestrel (LNG) in three of the OC formulations and norethisterone acetate (NEA) in the fourth. Results for the three LNG user groups were pooled. The changes in haematological variables observed over 12 months in the LNG and NEA users were examined in relation to the changes seen in the women not on OC. Women in Salvador differed markedly from those in the other three centres, in showing no acceleration of the prothrombin time and no increase in either fibrin plate lysis or plasminogen following the use of OC. After adjusting the findings in OC users for those in non-users, significant differences in response between centres were also detected for activated partial thromboplastin time (accelerated only in Dublin and Santiago), factor VII activity (increased mainly in Salvador and Santiago) and fibrinogen (for which the most marked changes were an increase in Dublin and a decrease in Salvador). This variability between centres in the effects of OC on coagulation and fibrinolysis suggests that OC administration in different populations may not carry equal thrombotic risks.
Adult↗
Emergency contraception: the politics of post-coital contraception.
The literature and events related to the politicization of emergency contraceptive pills (ECPs) in the United States is reviewed. The basis of opposition to the regimen, rooted in the mode of action of ECPs, the confusion with mifepristone, and the challenges this presents for ECP advocates is also discussed. Legislative actions that impact availability of ECPs are described, as well as efforts to increase access and availability through innovate programs, legislation, and changes in medical practice. Recommendations for future research, service delivery, and public policy are also presented.
Abortifacient Agents↗