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PubMed1988

A multicentred phase III comparative study of two hormonal contraceptive preparations given once-a-month by intramuscular injection: I. Contraceptive efficacy and side effects. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation.

Two once-a-month injectable contraceptive formulations, HRP112 (depot-medroxyprogesterone acetate, 25mg and estradiol cypionate, 5 mg) and HRP102 (norethisterone enantate, 50 mg and estradiol valerate, 5 mg) were compared in two groups of women with regard to effectiveness, reported complaints and reasons for discontinuation. A total of 2328 women were recruited into a seventeen-centre, randomized clinical trial. Follow-up was for a period of one year and resulted in a total of 10,969 women-months of experience of HRP112 and 10,608 women-months of experience with HRP102. The study showed little difference in efficacy and side-effects between the two formulations. Two pregnancies occurred in women receiving HRP102, giving a cumulative life-table pregnancy rate at 12 months of 0.18 per 100 woman-years. None occurred in the group receiving HRP112. There was no difference in the overall continuation rates between the two groups at one year, being 64.5% in the HRP112 group and 63.2% in the HRP102 group. The rates for all medical and non-medical reasons given for discontinuation were comparable between the two treatment groups. Discontinuations for bleeding irregularities were low, being 6.3% and 7.5% for HRP112 and HRP102 respectively, as well as for 'amenorrhea', the respective figures being 2.1% and 1.6%. There were, however, marked centre-to-centre differences. Both products were shown to be highly effective contraceptive preparations, which gave rise to few discontinuations due to menstrual cycle disturbances when compared with progestogen-only injectable contraceptives. As such it is expected that they will have an important role in family planning programmes in many countries throughout the world.

Adult↗
PubMed2005

Cost-effectiveness and contraceptive effectiveness of the transdermal contraceptive patch.

OBJECTIVE: The purpose of this study was to examine implications of increased perfect use on the cost-effectiveness of the contraceptive patch compared with combination oral contraceptives (COCs). STUDY DESIGN: This study compared the patch with low-estrogen-dose COCs. It assumes that the risks of developing a medical condition during use are the same for both the patch and COCs. Differences in net cost and pregnancies avoided during use were modeled. With the use of a pharmacoeconomic model, both methods were compared with a hypothetical reference case of contraception nonuse. The base-case model considered women, ages 15 to 50, in average health in a long-term, mutually monogamous, heterosexual relationship. RESULTS: The base-case analysis showed that use of the patch resulted in a savings of 249 US dollars and 0.03 pregnancies per woman over 2 years compared with COCs. CONCLUSION: This analysis demonstrated that patch use would be cost saving compared with COC use, resulting in a net avoidance of pregnancy for this population. The cost savings are attributed to reduced costs of pregnancy.

Administration, Cutaneous↗
PubMed2004

Immediate monthly combination contraception to facilitate initiation of the depot medroxyprogesterone acetate contraceptive injection.

Conventional clinical protocols specify that women initiate depot medroxyprogesterone acetate (DMPA) within 7 days of the onset of menses, and product labeling specifies initiation within 5 days. Women outside of this window should wait until next menses to begin, often leaving them with inadequate interim contraceptive protection. An alternative is for women to initiate monthly hormonal contraception immediately, as a bridge to DMPA, with a scheduled follow-up appointment about 4 weeks later. We evaluated bridge preferences and DMPA initiation among 150 women requesting DMPA who were ineligible for their first injection at the time of clinic visit due to menstrual cycle day. Ninety-eight percent (n = 147) rejected the standard protocol of waiting with condoms or abstinence in favor of a hormonal bridge method. Ninety-seven percent follow-up (n = 146) showed that 86% were satisfied with their bridge method. There were no posttreatment pregnancies, and 55% (n = 81) of participants had initiated DMPA or another long-term contraceptive within 4 weeks of their initial clinic presentation.

Adolescent↗
PubMed2005

Twenty micrograms vs. >20 microg estrogen oral contraceptives for contraception: systematic review of randomized controlled trials.

Concern about estrogen-related adverse effects has led to progressive reductions in the estrogen dose in combination oral contraceptives (COCs). This review of randomized controlled trials tested the hypothesis that COCs containing 20 microg in terms of contraceptive effectiveness, bleeding patterns, discontinuation and side effects. Data from the 18 eligible trials conducted to date are inadequate for detecting possible differences in contraceptive effectiveness. Several COCs containing 20 microg EE resulted in higher rates of early trial discontinuation (overall and due to adverse events such as irregular bleeding) as well as increased risk of bleeding disturbances (both amenorrhea/infrequent bleeding and irregular, prolonged, frequent bleeding or breakthrough bleeding or spotting) than their higher-estrogen comparison pills. However, most trials compared COCs containing different progestin types, and changes in bleeding patterns could be related to progestin type as well as estrogen dose. While health care providers and women might select COCs containing 20 microg EE based on theoretical improvements in safety profile from the reduced dose of estrogen, no evidence is available to support this choice.

Adult↗
PubMed2005

Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive.

This open-label, randomized study compared the pharmacokinetics of ethinylestradiol (EE) from the contraceptive vaginal ring NuvaRing (15 microg EE/day), the transdermal patch (20 microg EE/day) and a combined oral contraceptive (COC) containing 30 microg EE. After 2-8 weeks of synchronization by COC treatment, subjects were randomized to 21 days of treatment with NuvaRing, patch or COC. Analysis of area under the EE concentration-versus-time curve (AUC) during 21 days of treatment showed that exposure to EE in the NuvaRing group was 3.4 times lower than in the patch group (p < .05) and 2.1 times lower than in the pill group (p < .05). Serum EE levels of subjects showed much lower variation with NuvaRing than with the patch or the COC. Thus, exposure to EE was significantly lower with NuvaRing than with the patch and pill methods, demonstrating that NuvaRing is a low-estrogen-dose contraceptive method that also results in low estrogen exposure.

Administration, Cutaneous↗
PubMed2005

Measured and reported weight change for women using a vaginal contraceptive ring vs. a low-dose oral contraceptive.

BACKGROUND: Women often stop hormonal contraception because of perceived weight change. We conducted a randomized trial comparing the contraceptive vaginal ring to a low-dose oral contraceptive (OC). We examined the difference between women's reported and measured baseline weights and looked at factors affecting perceived weight change. METHODS: We randomized 201 participants to either the vaginal ring or an OC for three cycles. We weighed participants upon enrollment (n=194) and at exit (n=167), using the same instrument for all measurements. Participants also provided self-reported height and their reactions to perceived weight changes. RESULTS: Baseline weight and body mass index were similar for both groups (mean weight=145.9 lb). Measured weight was, on average, 4.4 lb more than reported weight; this difference was greater in overweight and obese participants. Participants gained an average of 2.8 lb over 3 months; this gain did not differ between groups or by baseline weight. Subjects who reported a "bad change" in weight at exit (n=34) gained an average of 4.4 lb, whereas those who reported "no change" (n=112) gained 2.2 lb and those who reported a "good change" (n=14) gained 3.3 lb. CONCLUSION: Participants underreported their weight, and this difference was greater for heavier women. There was little weight change for the women in our study. Participants' opinions about weight change were not correlated with measured weight changes.

Administration, Intravaginal↗
PubMed2006

Comparison of uterine concentrations of ethinyl estradiol and etonogestrel after use of a contraceptive vaginal ring and an oral contraceptive.

OBJECTIVE: To compare uterine tissue concentrations of ethinyl estradiol (EE) and etonogestrel (ENG) after one cycle of use of a contraceptive vaginal ring (NuvaRing; NV Organon, Oss, The Netherlands) or a combined oral contraceptive (COC). DESIGN: Randomized, open-label, pharmacokinetic study. SETTING: Obstetrics and gynecology unit. PATIENT(S): Eight premenopausal women about to undergo hysterectomy but otherwise healthy. INTERVENTION(S): One cycle (17-21 days) of NuvaRing or COC treatment that ended with surgical hysterectomy. MAIN OUTCOME MEASURE(S): Tissue concentrations of EE and ENG in uterine tissue samples taken from the upper myometrium and mid-myometrium, the cervical region, and the endometrium. RESULT(S): In both groups, concentrations of EE and ENG were similar in uterine tissue taken from the upper myometrium and mid-myometrium and the cervical region. However, compared with the COC group, concentrations of both hormones were markedly lower in tissue samples from the endometrium of women who had been treated with NuvaRing. CONCLUSION(S): Vaginal administration of hormones with NuvaRing did not produce elevated uterine concentrations of EE and ENG, compared with an oral contraceptive.

Administration, Intravaginal↗
PubMed2005

Change in contraceptive choices and the effect of education on use of contraception at the family planning clinic of Sişli Etfal Training and Research Hospital, Istanbul, Turkey.

OBJECTIVE: To investigate change in contraceptive use and the effect of education on fertility and contraceptive attitudes at our family planning clinic. METHODS: For this retrospective review, medical charts from Sişli Etfal Training and Research Hospital Family Planning Center were obtained. Records were evaluated for 2514 women in 1997 and 2268 women in 2002. RESULTS: During the 6-year period studied, significant decreases occurred in the number of births, elective abortions, gravidity and number of living children (p < 0.001). When the patterns of method use were compared, use of intrauterine devices and of coitus interruptus diminished whereas pill and condom use increased. Parallel with the rise in educational level, intrauterine device use declined whereas pill and condom use rose significantly (p < 0.001). CONCLUSION: The sociocultural and educational levels of women affect their contraceptive choices. Policies aimed at raising the socioeconomic and educational level of women should be supported to prevent maternal and fetal complications as a result of unwanted pregnancies.

Adult↗
PubMed1985

Invasive cervical cancer and combined oral contraceptives. WHO collaborative study of neoplasia and steroid contraceptives.

A multicentre, hospital based case-control study is being conducted under the auspices of the World Health Organisation to determine whether steroid contraceptives alter the risk of gynaecological, breast, and hepatic neoplasms. Preliminary results, largely from developing countries, on the relation between combined oral contraceptives and invasive cervical carcinoma showed a relative risk of 1.19 (95% confidence interval 0.99-1.44) in women who had ever used oral contraceptives. The risk increased with duration of use, giving a relative risk of 1.53 after five years. This finding supports a causal interpretation, but it could also be due to incomplete control for confounding sexual variables and other sources of bias.

Contraceptives, Oral↗
PubMed1996

Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women.

OBJECTIVE: To test whether use of combined oral contraceptives containing third generation progestogens is associated with altered risk of venous thromboembolism. DESIGN: Matched case-control study. SETTING: 10 centres in Germany and United Kingdom. SUBJECTS: Cases were 471 women aged 16-44 who had a venous thromboembolism. Controls were 1772 women (at least 3 controls per case) unaffected by venous thromboembolism who were matched with corresponding case for age and for hospital or community setting. MAIN OUTCOME MEASURES: Odds ratios derived with stratified analyses and unconditional logistic regression to adjust for potential confounding variables. RESULTS: Odds ratios (95% confidence intervals) for venous thromboembolism were: for any oral contraceptives versus no use, 4.0 (3.1 to 5.3); for second generation products (low dose ethinyl-oestradiol, no gestodene or desogestrel) versus no use, 3.2 (2.3 to 4.3); for third generation products (low dose ethinyloestradiol, gestodene or desogestrel) versus no use, 4.8 (3.4 to 6.7); for third generation products versus second generation products, 1.5 (1.1 to 2.1); for products containing gestodene versus second generation products, 1.5 (1.0 to 2.2); and for products containing desogestrel versus second generation products, 1.5 (1.1 to 2.2). Probability of death due to venous thromboembolism for women using third generation products is about 20 per million users per year, for women using second generation products it is about 14 per million users per year, and for non-users it is five per million per year. CONCLUSIONS: Risk of venous thromboembolism was slightly increased in users of third generation oral contraceptives compared with users of second generation products.

Adolescent↗
PubMed1996

Third generation oral contraceptives and risk of myocardial infarction: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women.

OBJECTIVE: To test whether use of combined oral contraceptives containing third generation progestogens is associated with altered risk of myocardial infarction. DESIGN: Matched case-control study. SETTING: 16 centres in Austria, France, Germany, Switzerland, and the United Kingdom. SUBJECTS: Cases were 153 women aged 16-44 with a myocardial infarction event. Controls were 498 women (at least 3 controls per case) unaffected by myocardial infarction who were matched with their corresponding case for age and for hospital or community setting within four months of the index infarction. MAIN OUTCOME MEASURES: Odds ratios derived with stratified analyses and unconditional logistic regression to adjust for potential confounding variables. RESULTS: The estimated odds ratio for myocardial infarction of third compared with second generation oral contraceptives among all 651 study subjects was 0.36 (95% confidence interval 0.1 to 1.2) (P = 0.11). The odds ratio for the United Kingdom and Germany alone was 0.45 (0.1 to 1.8) (P = 0.26). Other odds ratios for the five countries were 3.1 (1.5 to 6.3) (P = 0.003) for use of second generation products v no current use and 1.1 (0.4 to 3.4) (P = 0.9) for use of third generation products v no current use. Among the confounding variables the independent contribution of smoking (for which adjustment was made in the above estimates) proved to be important (10.1 (5.7 to 17.9), P < 0.001). CONCLUSION: An odds ratio of 0.45 with wide confidence intervals shows that third generation oral contraceptives compared with second generation products are associated with a reduced risk of myocardial infarction or with no difference. This finding from an interim analysis should be interpreted with extreme caution. However, the excess risk of venous thromboembolism associated with the use of third generation products may be balanced by the reduced risk of myocardial infarction associated with the same products.

Adolescent↗
PubMed1997

Intrauterine contraceptive devices and antigestagens as emergency contraception.

Although the Yuzpe regimen of emergency contraception is the one most commonly used, there are alternatives. Copper-containing intrauterine devices are very effective and can be inserted for at least 5 days after unprotected intercourse and sometimes longer. They may, however, transmit pre-existing infection into the upper genital tract and cause discomfort when being fitted. Progestogen-only emergency contraception appears, from WHO studies, to be a useful adjunct to current therapies. Mifepristone has been studied in various doses and has been shown to be very effective but is not yet commercially available. Health services should provide a full range of methods including emergency contraception by appropriately trained people in an acceptable environment.

Contraceptives, Oral, Synthetic↗
PubMed2002

Contraceptive efficacy and tolerability with a novel combined contraceptive vaginal ring, NuvaRing.

NuvaRing is a novel combined contraceptive vaginal ring that releases 15 microg of ethinylestradiol and 120 microgram etonogestrel per day. Each ring is used for one cycle, comprising 3 weeks continuous use of the ring followed by a 1-week ring-free period. The contraceptive efficacy and safety of NuvaRing have been studied in a 1-year, open study conducted in 1,145 women. Six pregnancies occurred in 12,109 cycles of exposure, giving a Pearl index of 0.65 (95% confidence interval (CI), 0.24-1.41). However, three of the six women violated the NuvaRing regimen in the cycle of conception. Compliance with the prescribed regimen was high, with criteria being fulfilled in 90.8% of cycles. During the 1 year of the study, 41% of the women did not experience any adverse events. The most frequently reported treatment-related adverse events were headache (6.6%), leukorrhea (5.3%) and vaginitis (5.0%). There was a low incidence of estrogen-related adverse events such as nausea (2.8%) and breast tenderness (1.9%). A total of 173 women (15.1%) discontinued due to an adverse event, with device-related events (comprising ring expulsion, foreign body sensation or coital problems) being the most commonly reported (2.6%). There were no clinically relevant changes in blood biochemistry, hematology, blood pressure, heart rate, body weight, physical examination or cervical cytology. In conclusion, NuvaRing is an effective contraceptive that is well tolerated, has a good safety profile and is not associated with unwanted effects on the cervix.

Consumer Product Safety↗
PubMed1973

Ceylon: continuing practice of contraception by acceptors of oral contraceptives and intrauterine devices in a field programme.

A follow-up study of oral-contraceptive and intrauterine-device acceptors in the early years of the Ceylon family planning programme was undertaken to determine the effect of a 1968 policy decision to cut the per cycle price of oral contraceptives by half and to allow nonclinical prescription and distribution of the pills by trained field midwives under medical supervision. While pill acceptance increased, study findings suggest that continuation did not. On balance, the intrauterine device proved much more effective than oral contraceptives in preventing unplanned pregnancies, reflecting the higher continuation rates of IUD acceptors. Although the availability of both methods clearly contributed to expansion of the programme, the demographic and administrative implications of initial choice of method, and the finding that pregnancy rates for pill users are not lower than for IUD wearers, suggest the need for more realistic counselling by clinic and field staff at the time of choice.

Adult↗
PubMed1980

[Medicamentous enzyme induction and hormonal contraception. First communication: effects of anti-epileptics on hormonal contraception of epileptics (author's transl)].

Studies were conducted into the effects of anti-epileptics on hormonal contraception of epileptics, with reference being primarily made to biochemical as well as clinicoexperimental findings regarding medication and its effects, through the mechanism of medicamentous enzyme induction, on biological transformation of steroid hormones. Disorders of bleeding, the most sensitive symptom of enzyme induction, occurred more often than they did in a control group, the difference in occurrence being secured with significance. Contraceptive protection of those patients was equally reduced. Conclusions were drawn for contraceptive practice.

Adult↗
PubMed1995

[Profile of the user and tolerance of main contraceptive methods in primary care: hormonal contraceptives, intrauterine devices (IUD) and diaphragm].

OBJECTIVE: To analyse the psycho-social profile of women using hormonal contraceptives (HCC), the intrauterine device (IUD) and the diaphragm; and to evaluate their tolerance to these methods. DESIGN: A prospective observation study. SETTING: The basic unit of family planning at an urban health centre. PATIENTS AND OTHER PARTICIPANTS: 503 patients, for whom contraception was provided between january and may 1992, with a clinical follow-up throughout the year. MEASUREMENTS AND MAIN RESULTS: HCC were administered to 285 women, with an average age of 24.8# 4.38 years. Secondary effects were detected in 14.73% of cases, with good metabolic tolerance. The IUD was provided to 216 users, with an average age of 35.4#-6.39. There was acceptable tolerance, with it being withdrawn in 18 cases, mainly due to spontaneous shedding. There were only two diaphragm users during the study period; and these had good tolerance. CONCLUSIONS: HCC were the contraceptive method chosen most often by younger women. The high tolerance to these methods and easy out-patient control of them make Primary Care, in coordination with other professionals, the ideal level for their prescription. User profiles approach the ideal recommended in the bibliography consulted.

Adult↗
PubMed1993

Contraceptive efficacy of a monophasic oral contraceptive containing desogestrel.

Desogestrel, a new gonane progestin, has been shown to be comparable in efficacy with oral contraceptives currently in use in the United States. Results from several large efficacy studies conducted in Europe encompassing 42,640 patients in 183,212 cycles resulted in six pregnancies for a Pearl index of 0.04. This low rate, which was compared with those observed in recent U.S. clinical trials, reflects differences in study methodology. An additional indicator of an oral contraceptive's efficacy is its ability to suppress ovarian function, including follicular development and increases in plasma estradiol levels. Desogestrel has been found to be among the strongest suppressors of ovarian activity.

Contraceptives, Oral↗
PubMed1993

A randomized trial of three oral contraceptives: comparison of bleeding patterns by contraceptive types and steroid levels.

OBJECTIVE: Our purpose was to determine the relationship between bioavailability of contraceptive steroids and bleeding patterns. STUDY DESIGN: A randomized clinical trial evaluated 192 women on 50 micrograms of ethinyl estradiol and 1.0 mg of norethindrone (OC1), 35 micrograms ethinyl estradiol and 1.0 mg of norethindrone (OC2), and 35 micrograms ethinyl estradiol and 0.5 mg norethindrone (OC3) over nine cycles. RESULTS: Intermenstrual bleeding rates were higher for OC3 when compared with OC1 (p = 0.01). The number of intermenstrual bleeding days was highest for OC3 (p = 0.001) and higher for OC2 when compared with OC1 (p < 0.006). The onset of withdrawal bleeding occurred faster in OC3 patients (p < 0.02). Bioavailability of both contraceptive steroids as measured by baseline values and 1-hour slopes did not correlate with bleeding patterns at 3, 6, and 9 months of use. CONCLUSION: These data suggest that differences in biologic responses associated with pill use cannot be explained solely on the basis of these particular hormone measurements.

Biological Availability↗