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PubMed2000

Increased fibrinolytic activity during use of oral contraceptives is counteracted by an enhanced factor XI-independent down regulation of fibrinolysis: a randomized cross-over study of two low-dose oral contraceptives.

The effect of oral contraceptives (OC) on fibrinolytic parameters was investigated in a cycle-controlled cross-over study in which 28 non-OC using women were randomly prescribed either a representative of the so-called second (30 microg ethinylestradiol, 150 microg levonorgestrel) or third generation OC (30 microg ethinylestradiol, 150 microg desogestrel) and who switched OC after a two month wash out period. During the use of OC, the levels of tissue-type plasminogen activator (tPA) activity, plasminogen, plasmin-alpha2-antiplasmin complexes and D-dimer significantly increased (by 30 to 80%), while the levels of plasminogen activator inhibitor- (PAI-1) antigen, PAI-1 activity and tPA antigen significantly decreased (25 to 50%), suggesting an increase in endogenous fibrinolytic activity. These OC-induced changes were not different between the two contraceptive pills. TAFI (thrombin-activatable fibrinolysis inhibitor) levels increased on levonorgestrel, and even further increased on desogestrel. A clot lysis assay that probes both fibrinolytic activity and the efficacy of the coagulation system to generate thrombin necessary to down regulate fibrinolysis via TAFI showed no change of the clot lysis time during OC use. This finding suggests that the OC-induced increase in endogenous fibrinolytic activity is counteracted by an increased capacity of the coagulation system to down regulate fibrinolysis via TAFI. Indeed we observed that during OC use there was a significant increase of F1+2 generation during clot formation. When these assays were performed in the presence of an antibody against factor XI, we observed that the clot lysis time was significantly increased during OC use and that the increase in F1+2 generation during OC therapy was due to a factor XI-independent process, which was significantly higher on desogestrel than on levonorgestrel. These data indicate that the OC-induced inhibition of endogenous fibrinolysis takes place in a factor XI-independent way and is more pronounced on desogestrel than on levonorgestrel-containing OC.

Adolescent↗
PubMed1980

[Nosology of contraceptives: hematological and ultrastructural observations after experimental administration of low dosage contraceptives (author's transl)].

A further experimental study on changes produced in rabbits by low dosage contraceptives is presented. The administration has been continued for six months. Serum biochemical and hepatic ultrastructural findings are in agreements with literature data. On the contrary the early changes of cardiac microcirculation and chiefly renal glomerular tuft seem to be rather unusual. The weight to be attached to the knowledges descending from the presented data in assessing allowance of contraceptive treatments in human subjects and aiming preventive medicine purposes is emphasized.

Animals↗
PubMed1997

Acute myocardial infarction and combined oral contraceptives: results of an international multicentre case-control study. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.

BACKGROUND: The association between oral contraceptive (OC) use and acute myocardial infarction (AMI) was established in studies from northern Europe and the USA, which took place during the 1960s and 1970s. Few data are available to quantify the risk worldwide of AMI associated with use of OCs introduced since those early studies. This hospital-based case-control study examined the association between a first AMI and current OC use in women from Africa, Asia, Europe, and Latin America (21 centres). METHODS: Cases were women aged 20-44 years who had definite or possible AMI (classified by history, electrocardiographic, and cardiac-enzyme criteria), who were admitted to hospital, and who survived for at least 24 h. Up to three hospital controls matched by 5-year age-band were recruited for each of the 368 cases (941 controls). All participants were interviewed while in hospital with the same questionnaire, which included information on medical and personal history, lifetime contraceptive use, and blood-pressure screening before the most recent episode of OC use. Odds ratios compared the risk of AMI in current OC users and in non-users (past users and never-users combined). FINDINGS: The overall odds ratio for AMI was 5.01 (95% CI 2.54-9.90) in Europe and 4.78 (2.52-9.07) in the non-European (developing) countries; however, these risk estimates reflect the frequent coexistence of other risk factors among OC users who have AMI. Very few AMIs were identified among women who had no cardiovascular risk factors and who reported that their blood pressure had been checked before OC use; odds ratios associated with OC use in such women were not increased in either Europe or the developing countries. Among OC users who smoked ten or more cigarettes per day, the odds ratios in Europe and in the developing countries were over 20. Similarly, among OC users with a history of hypertension (during pregnancy or at any other time), odds ratios were at least ten in both groups of countries. No consistent association between odds ratios for AMI and age of OC users or oestrogen dose was apparent in either group of countries. No significant increase in odds ratios was apparent with increasing duration of OC use among current users, and odds ratios were not significantly increased in women who had stopped using OCs, even after long exposure. The study had insufficient power to examine whether progestagen dose or type had any effect on AMI risk. INTERPRETATION: Current use of combined OCs is associated with an increased risk of AMI among women with known cardiovascular risk factors and among those who have not been effectively screened, particularly for blood pressure. AMI is extremely rare in younger (< 35 years) non-smoking women who use OCs, and the estimated excess risk of AMI in such women in the European centres is about 3 per 10(6) woman-years. The risk is likely to be even lower if blood pressure is screened before, and presumably during, OC use. Only among older women who smoke is the degree of excess risk associated with OCs substantial (about 400 per 10(6) woman-years).

Adult↗
PubMed1992

Contraceptive compliance with a levonorgestrel triphasic and a norethindrone monophasic oral contraceptive in adolescent patients.

OBJECTIVE: This study was undertaken to assess the impact of two low-dose oral contraceptive pills on compliance and side effects in adolescent patients. STUDY DESIGN: The use of a levonorgestrel-containing triphasic pill (N = 114) was compared with that of a monophasic (1 + 35) norethindrone-containing pill (N = 110) at two different sociodemographic sites. RESULTS: No significant difference in compliance or pill satisfaction was observed between the pills. Socioeconomic factors were the overriding predictors of compliance. At 3 and 12 months of follow-up, there were significantly fewer complaints of overall side effects (p less than 0.001 and p = 0.004, respectively), breakthrough bleeding (p = 0.017 and p = 0.018), and pill amenorrhea (p = 0.002 and p less than 0.001) among users of the triphasic pill. Mean weight change at 12 months was +1.1 kg for the monophasic pill and -0.1 kg for the triphasic pill. All known pregnancies occurred among noncompliant city clinic patients. CONCLUSIONS: Adolescents experienced fewer side effects with the triphasic pill than with the monophasic one, but compliance was the same.

Adolescent↗
PubMed1998

Oral contraceptive use before and after the latest pill scare in The Netherlands. Changes in oral contraceptive use and how users change.

In October 1995, a "pill scare" developed in Europe. In the Netherlands, the recommendations given were 1) to not alarm women without risk for deep vein thrombosis (DVT), and 2) to be reserved in prescribing third generation oral contraceptives (OC) for young women who were beginning OC use. To determine whether there is a change in the prescription of third generation OC after the latest pill scare, prescription data from 1/10/94 to 1/10/96, covering a population of +/- 120,000 persons, were studied with respect to OC use before and after the pill scare. Trend analyses revealed a significant decline in third generation compared with total OC prescribing only in the youngest age category (p = 0.0034). Further, switch behavior was studied. Switches from third to second generation OC were more prevalent after the pill scare than before (odds ratio = 2.63; 95% confidence interval 1.84-3.75) and switches from second to third generation OC were significantly less prevalent after the pill scare. This indicates that Dutch prescribers have reacted to the pill scare in the way that the government recommended.

Adolescent↗
PubMed1991

Oral contraceptives, androgens, and the sexuality of young women: I. A comparison of sexual experience, sexual attitudes, and gender role in oral contraceptive users and nonusers.

Female undergraduates (108) volunteered for a study of hormones and sexuality, 55 of whom were oral contraceptive (OC) users. In this paper, OC users and nonusers are compared on measures of sexual attitudes and behavior, use of erotic fantasy, and gender role. In the second paper, the effects of OC on androgen levels and the relationship between androgens and behavioral measures within each group are reported. OC users were more likely to have a current sexual partner and less likely to be virgins. The two groups did not differ in frequency of masturbation or use of erotic fantasies. OC users reported less restrictive sexual morality and more interest in erotic images. These differences persisted when women without current partners were excluded. Among those in active sexual relationships, OC users reported more frequent sexual intercourse, higher psychosexual motivation and enjoyment, and were more positive in their evaluation of their partners than OC nonusers.

Adult↗
PubMed2006

Weight gain in obese and nonobese adolescent girls initiating depot medroxyprogesterone, oral contraceptive pills, or no hormonal contraceptive method.

OBJECTIVE: To examine weight changes in a large cohort of obese and nonobese adolescent girls initiating depot medroxyprogesterone acetate (DMPA), an oral contraceptive (OC), or no hormonal contraceptive method (control). DESIGN, SETTING, AND PARTICIPANTS: Prospective study of 450 adolescent girls, aged 12 to 18 years, who attended 4 urban health clinics and selected DMPA, OC, or control. Data collection occurred at baseline and at 6, 12, and 18 months; consisted of structured interview and measurement of height and weight; and occurred from April 19, 2000, through September 26, 2003. MAIN OUTCOME MEASURE: Weight was examined as mean change over 18 months and actual weight at each study visit. On the basis of preliminary analyses, we stratified the sample according to baseline obesity status (nonobese, body mass index [calculated as weight in kilograms divided by the square of height in meters] < 30; obese, body mass index > or =30). RESULTS: Adolescent girls who were obese at initiation of DMPA gained significantly more weight than did obese girls starting OC or control (P<.001 for both). At 18 months, mean weight gain was 9.4, 0.2, and 3.1 kg for obese girls receiving DMPA, receiving OC, and control, respectively. Weight gain in obese girls receiving DMPA was also greater than weight gain in all nonobese categories (4.0 kg, DMPA; 2.8 kg, OC; 3.5 kg, control; P<.001). A significant interaction (P = .006) between length of time receiving DMPA and weight gain was evident for obese subjects. CONCLUSIONS: Over 18 months, DMPA use was associated with increasing rates of weight gain in obese subjects. The potential contribution to severe obesity in this population is concerning.

Adolescent↗
PubMed1991

Risk of breast cancer in relation to use of combined oral contraceptives near the age of menopause. WHO Collaborative Study of Neoplasia and Steroid Contraceptives.

Data from a multinational, hospital-based, case-control study were analyzed to determine whether use of combined oral contraceptives (OC) around the time of menopause preferentially increases risk of breast cancer. Results show that the relative risk (RR) of breast cancer was increased in women of all ages who had used oral contraceptives within the past year, but not to a greater extent in women near the age of menopause than in younger women. RRs did not increase with duration of OC use after age 45 in either pre- or postmenopausal women. RRs also were not found to be higher in women who were using OCs near the time of either a natural or artificial menopause than in women who used them at other times. This study thus provides no support for the hypothesis that OCs enhance risk of breast cancer by a greater amount when taken around the time of menopause than when taken at other times.

Adult↗
PubMed1989

The WHO multicentre trial of the vasopressor effects of combined oral contraceptives: 2. Lack of effect of estrogen. Task Force on Oral Contraceptives. WHO Special Programme of Research, Development and Research Training in Human Reproduction.

Changes in blood pressure were measured in a randomized double-blind trial of 680 women using oral contraceptives containing either 50 or 30 ug of ethinyl estradiol combined with 250 mg levonorgestrel. The trial was done in 6 centres in Thailand, India, Zambia, Cuba, The Philippines, and Hungary. There were no significant differences between the two pills at any of 4 follow-up visits at approximately 3, 6, 9 and 12 months, nor in the life-table probability of developing hypertension within one year. These findings are evidence against the hypothesis that it is the estrogen in oral contraceptives which causes their vasopressor effect.

Adolescent↗
PubMed1994

Long-term contraceptive effects of intrauterine neem treatment (IUNT) in bonnet monkeys: an alternate to intrauterine contraceptive devices (IUCD).

Antifertility effects of intrauterine neem treatment (IUNT) was studied in bonnet monkeys. A single administration of 1 ml of neem oil by an intrauterine insemination catheter blocked fertility for 7 to 12 months. The effect was, however, reversible as all the animals became pregnant subsequently and delivered normal babies. The neem oil treatment had no adverse effect on menstrual cyclicity and ovarian functions. The uterus of neem-treated animals showed normal morphology. Immunohistological studies, however, demonstrated a significant increase in the number of MHC-II antigen-positive cells in the uterine endometrium following neem treatment, indicating enhanced antigen-presenting ability of the uterus; a feature that may be related to the observed antifertility effect of neem oil. The present investigation demonstrates that an IUNT can be used for long-term, reversible contraception, without any apparent side effects, and that the method could provide an alternate to currently used intrauterine contraceptive devices (IUCD).

Animals↗
PubMed1995

A multinational case-control study of cardiovascular disease and steroid hormone contraceptives. Description and validation of methods. World Health Organization Collaborative Study of Cardiovascular and Steroid Hormone Contraception.

A hospital-based, case-control study of the association between current usage of oral contraceptives and first-time cases of acute myocardial infarction, stroke, or a venous thromboembolic event (deep vein thrombosis or pulmonary embolus) was carried out in 17 countries from four regions (Africa, Asia, Europe, and Latin America). A total of 3792 cases and 10,281 hospitalised controls matched for age were recruited during a 4-year period, ending in June 1993. The study was designed to have sufficient power to detect a relative risk of 2 for developing each of the three study diseases, associated with current oral contraceptive use in each of the four regions, with the exception of acute myocardial infarction (for which all non-European regions were to be combined) and for venous thromboembolic events in Asia, where these disorders are rare. This report describes the background, pilot study, methods, and the analyses carried out to validate the methods used in the study.

Acute Disease↗
PubMed2001

Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20.

This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 microg)/ethinyl estradiol 25 microg regimen (Ortho Tri-Cyclen Lo) (n = 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 microg (Loestrin Fe 1/20) (n = 1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. Breakthrough bleeding and spotting was reported by a significantly lower percentage of participants in the Ortho Tri-Cyclen Lo group compared with the Loestrin Fe 1/20 group. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens.

Administration, Oral↗
PubMed1986

ICMR (Indian Council of Medical Research) Task Force on Hormonal Contraception. Return of fertility following discontinuation of an injectable contraceptive--norethisterone oenanthate (NET EN) 200mg dose. Council of Medical Research.

The return of fertility following discontinuation of norethisterone oenanthate (NET EN) 200 mg injectable contraceptive after use for a minimum period of six months or more was studied in 69 women who discontinued the method for planning pregnancy. Former users of copper intra-uterine device (CuT 200) were enrolled as a control group. Another 161 women who had discontinued NET EN due to other reasons (e.g. amenorrohea, excessive bleeding or personal reasons) were also studied for return of fertility after ensuring that they were not using any other method of contraception and were exposed to the risk of pregnancy. The subjects from both groups were followed for a period of one year. The cumulative conception rates at one year were 72.5 and 83.6 per 100 subjects for ex-NET EN and ex-CuT 200 users who had discontinued the method for planning pregnancy and this difference was not statistically significant (P greater than 0.05). The median time for conception for ex-NET EN users was 7.8 months as compared to 3.7 months in ex-CuT 200 users but the cumulative conception rates at the end of one year show that future return of fertility in NET EN users does not appear to be adversely affected. In 51 subjects who had discontinued NET EN due to amenorrhoea, the return of fertility was predictably slower and less. The return of fertility in subjects who discontinued NET EN for other reasons (e.g. excessive bleeding and other personal reasons) was similar to ex-NET EN and ex-CuT 200 users.

Adult↗
PubMed1999

Effect on stroke of different progestagens in low oestrogen dose oral contraceptives. WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.

The multicentre WHO collaborative case-control study had limited power to differentiate stroke risks by progestagen component in low dose combined oral contraceptives. Given this caveat, odds ratios for ischaemic, haemorrhagic, and all strokes combined associated with use of oral contraceptives containing desogestrel or gestodene ("third generation") were found to be similar to those containing levonorgestrel in this study.

Adult↗
PubMed1990

Breast cancer and combined oral contraceptives: results from a multinational study. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives.

A collaborative, hospital-based case-control study was conducted at 12 participating centres in 10 countries. Based on data from personal interviews of 2,116 women with newly diagnosed breast cancer and 12,077 controls, the relative risk of breast cancer in women who ever used oral contraceptives was estimated to be 1.15 (1.02, 1.29). Estimated values of this relative risk based on data from three developed and seven developing countries were 1.07 (0.91, 1.26) and 1.24 (1.05, 1.47) respectively; these estimates are not significantly different (P = 0.22). Estimates for women under and over age 35 were 1.26 (0.95, 1.66) and 1.12 (0.98, 1.27), respectively, and these estimates are also not significantly different (P = 0.38). Risk was highest in recent and current users and declined with time since last use regardless of use. Risk did not increase with duration of use after stratifying on time since last use. Risk did not increase significantly with increasing duration of use before age 25 or before a first live birth. However, a relative risk of 1.5 that was of borderline statistical significance was observed in women who used oral contraceptives for more than 2 years before age 25. No single source of bias or confounding was identified that could explain the small increases in risk that were observed. Chance alone is also an unlikely explanation. The results could be due to a combination of chance and potential sources of bias, or they could represent a weak causal relationship.

Adult↗
PubMed2004

Concomitant administration of lumiracoxib and a triphasic oral contraceptive does not affect contraceptive activity or pharmacokinetic profile.

This study evaluated the effect of lumiracoxib on the pharmacokinetics and pharmacodynamics of ethinyl estradiol (EE) and levonorgestrel (LN) in Triphasil-28 (a triphasic oral contraceptive). Females stabilized on Triphasil-28 continued on Triphasil-28 alone for another month (Treatment Period 1), then also received lumiracoxib (400 mg daily) or placebo for 28 days each (Periods 2 and 3) in a double-blind crossover design. Plasma pharmacokinetic profiles were assessed on Day 21 of Periods 2 and 3. Progesterone and plasma sex hormone binding globulin (SHBG) concentrations were measured before and 2 hours after Triphasil-28 administration on Day 21 of all three treatment periods. Lumiracoxib had no significant effect on EE or LN pharmacokinetics or on progesterone or SHBG concentrations, indicating that anovulation and Triphasil-28 effectiveness was maintained. Adverse events were similar for lumiracoxib and placebo. Therefore, no clinically important consequences are anticipated if lumiracoxib is coadministered with oral contraceptives containing EE or LN.

Adolescent↗
PubMed1999

Oral progestogen-only contraceptives and cardiovascular risk: results from the Transnational Study on Oral Contraceptives and the Health of Young Women.

BACKGROUND: The risk of cardiovascular disease associated with progestogen-only pills has rarely been studied so far. METHODS: In the Transnational case-control study we were looking for a potential cardiovascular disease risk with oral progestogen-only pills in women aged 16-44 years. A total of 1058 cases of myocardial infarction, thromboembolic cerebrovascular accident or venous thromboembolism, and 3808 controls unaffected by these diseases, were enrolled. The group of women who had either used oral progestogen-only pills or no oral contraceptives included 394 cardiovascular disease cases (123 cases of myocardial infarction, 90 cases of thromboembolic cerebrovascular accident and 181 cases of venous thromboembolism) and 2366 controls. RESULTS: The adjusted (matched) odds ratio (OR) for all cardiovascular diseases combined for women using progestogen-only pills compared with non-users of oral contraceptives was 0.84 (95% confidence interval (CI), 0.45-1.58). The adjusted ORs for myocardial infarction, thromboembolic cerebrovascular accidents and venous thromboembolism for users of progestogen-only pills were 0.94 (95% CI, 0.31-2.91), 1.60 (95% CI, 0.24-0.72) and 0.68 (95% CI, 0.28-1.66), respectively. Hence, there was no significant increase in cardiovascular disease risk associated with progestogen-only pill use. The association between cardiovascular disease and established risk factors (smoking and hypertension) was confirmed. CONCLUSION: Although limited by the small number of exposed cases, our data suggest that there is no convincing evidence for an increased risk of cardiovascular disease associated with progestogen-only pill use.

Adolescent↗
PubMedDate not supplied

[Contraception and subsequent fertility. General review on the reversibility of oral contraception].

We have carried out a general review of the problem of reversing the contraceptive mehtods using oestrogen-pregestogen contraceptives. We have very carefully reviewed the onset of long cycles showing clearly that they occur more easily in women who have started with irregular cycles, as do post-pill amenorrhoea cases. Spontaneous abortions seem to occur just as often after the pill as in the general population and the alarm that was raised by D. Carr seems to us to be very exaggerated. The infants are normal, have a lower perinatal mortality when we take into account the patients who use this method and there are no more congenital abnormalities than in other patients.

Abnormalities, Drug-Induced↗