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PubMed1990

Oral contraceptives and risk of breast cancer.

A national population-based case-control study was conducted in New Zealand to assess the effects of hormonal contraception on breast-cancer risk. A total of 891 women aged 25 to 54 with a first diagnosis of breast cancer, and 1864 control subjects, randomly selected from the electoral rolls, were interviewed. The relative risk of breast cancer for women who had ever used oral contraceptives was 1.0 (95% confidence interval 0.82-1.3). There was no increase in risk with duration of use, even among women who had continued to use oral contraceptives for 14 or more years (relative risk = 1.1, 95% confidence interval 0.78-1.7). The risk of breast cancer was not increased by use of oral contraceptives for long periods before the first pregnancy or by starting use at a young age. Parity, age at menarche, family history of breast cancer, or history of benign breast disease did not modify the effect of oral contraceptives on breast-cancer risk. Relative risk estimates were slightly, although not significantly, increased during the first few years after starting oral contraception and in women under 35 years of age at diagnosis.

Adolescent↗
PubMed1991

Role of phase IV trials in determining the safety and efficacy of oral contraceptives. Guidelines for evaluation.

The continued evaluation of a new drug after it reaches the general marketplace is of ever-increasing concern for pharmaceutical manufacturers and regulatory agencies. This interest in performance after the drug has come to market has spawned a new type of research, "postmarketing surveillance," or phase IV research. Often when a new drug comes to market, a phase IV trial is implemented to reevaluate the results of previously performed controlled clinical trials. While the primary strength of a phase IV trial is that it gathers a large amount of prospective data on many patients in a short time, this type of study is limited in design as compared to the rigorous, randomized clinical trial required to "prove" efficacy. This paper offers the obstetrician-gynecologist and clinical epidemiologist a 10-point checklist to employ when evaluating phase IV trials involving an oral contraceptive.

Clinical Trials as Topic↗
PubMed1978

An evaluation of male contraceptive acceptance in rural Ghana.

To evaluate the effect of male contraceptive acceptance on fertility, the Danfa Family Planning Project in rural Ghana studied a sample of its male family planning acceptors. The findings show that half of the survey respondents accepted foam for use by their partners and half accepted the condom. The continuation rate (69 percent at 12 months) and use-effectiveness rate (80 percent at 12 months) reported by men were higher than those reported by women program acceptors. It is felt that men can play a significant role in affecting fertility through their influence on a couple's choosing to use contraception and as a result of their motivation to obtain contraception and see that it is used. It is urged that increasing emphasis be placed on providing family planning services for men in African programs.

Adolescent↗
PubMed2006

Successful treatment of depot medroxyprogesterone acetate-related vaginal bleeding improves continuation rates in adolescents.

High discontinuation rates for depot medroxyprogesterone acetate (DMPA) in adolescents may contribute to the number of unintended pregnancies. Many cite vaginal bleeding as a reason for discontinuing DMPA use. In this study, we attempted to determine if treating DMPA-associated vaginal bleeding with monophasic oral contraceptive pills (OCP) raised continuation rates. A total of 131 patients who reported vaginal bleeding while on DMPA were included in this study and 83 were treated with monophasic OCP. Of those who received OCP, 38.7% reported that vaginal bleeding stopped completely, 51.8% reported that vaginal bleeding stopped temporarily, and 6.0% reported no change. Overall, 94% of enrolled patients who received OCP as a treatment for DMPA-associated vaginal bleeding continued DMPA use. Our findings indicate that vaginal bleeding due to DMPA can be successfully treated, leading to improvement in continuation rates.

Adolescent↗
PubMed1991

Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS.

A levonorgestrel-releasing IUD and the Copper T 380Ag IUD were in randomized comparison for seven years in five clinics. In two other clinics the randomized study was truncated at five years, but use of the Copper T continued. No pregnancies occurred to users of either device in years 6 and 7. Cumulative pregnancy rates were 1.1 per 100 at seven years for the steroid-releasing and 1.4 per 100 for the copper-releasing IUDs. Cumulative rates of PID did not differ between devices. Infection rates appeared to be lowest during the sixth and seventh years of the study. Termination attributable to amenorrhea was the principal contributor to differences in cumulative continuation rates between devices. At the five clinics that carried the comparative study to seven years, cumulative continuation rates were 24.9 per 100 for LNg20 IUD users and 29.4 per 100 for TCu 380Ag users. Women who used either method for periods of five to seven years experienced, on average, marked to mild increases in hemoglobin as compared with levels at admission. The Copper T380 family and the LNg20 IUDs represent the most effective reversible contraceptive methods yet studied in long-term randomized trials.

Adolescent↗
PubMed1990

[Prevalence of cholelithiasis in relation to use of hormonal contraceptives].

UNLABELLED: 400 women in continuous care of a family planning clinic were examined for gallbladder stones by standard ultrasound technique. Gallstones (GS) are found infrequently in nulliparous women (3.1 percent). The prevalence of GS increases with number of births and with age: 11 percent of female under 25 years of age, who have ever born, have GS; women aged 45 years and older who have born two or more children have GS in 35 percent. Duration of use of HC increases with rising age and with number of births. There is no regular relationship between duration of use of HC or total dose respectively and prevalence of gallbladder stones. CONCLUSION: Intake of HC has no or only a marginal influence on prevalence of gallbladder stones.

Adult↗
PubMed1995

Performances of copper T 380A and multiload copper 375/250 intrauterine contraceptive devices in a comparative clinical trial.

An evaluation of the performances of copper T 380A (TCU 380A) and multiload copper 375/250 (MLCU 375/250) intrauterine contraceptive devices (IUCDS) was carried out at University College Hospital, Ibadan, Nigeria (UCH) in a clinical comparative trial. The IUCDS showed similar low vent rates at one year of continuous use. The difference in cumulative net probabilities for termination due to pelvic inflammatory disease was weakly significant at the sixth month of follow up with MLCU 250 having the highest rate. (TCU 380A-0%; MLCU 375-0%; MLCU 250-3.1%; X2 = 6.0; P < 0.05). This significant difference disappeared by the twelfth month of continuous use. Likewise, the difference in cumulative net probabilities for overall termination was significant at six months and insignificant at twelve months of follow up. The continuation rate after one year were 86%, 92% and 87% respectively for TCU 380A, MLCU 375 and MLCU 250. These rates were higher than 80% and 51% quoted for the previously available Lippes loop in the same environment [1,2]. It was therefore concluded that the three IUCDS are comparable in performances in the first year of use and could be used at our family planning clinic or any other clinic in a similar setting.

Adult↗
PubMed1998

Contraception with two levonorgestrel rod implants. A 5-year study in the United States and Dominican Republic.

A 5-year trial of a two-rod contraceptive implant, which releases the progestin levonorgestrel (LNG rod), was conducted at four clinics with 594 women. Mean age and weight at admission were 25.5 years and 62.4 kg, respectively. Consent to continue through 5 years was sought and obtained when the 3-year cumulative pregnancy rate proved to be 0.8 per 100. No pregnancies occurred in the fourth or fifth years. The 5-year cumulative pregnancy rate was, therefore, 0.8 per 100 with an annual average pregnancy rate below 2 per 1000 women. Prolonged bleeding/spotting (8.2% of subjects) and irregular bleeding (5.6%) were the most frequently cited medical reasons for removal. Removals for headache (4.7%) and weight change (4.0%) were the next most frequent medical reasons. Between 1% and 2% of subjects during the 5-year trial sought removals for each of the following conditions: mood changes, lower abdominal pain, depression, or pain at the implant site. The mean annual continuation rate during the study was 77 per 100. Use per woman averaged 2.96 years. Mean removal time was 5.9 +/- 0.6 min. These data indicate that, for a 5-year period, the two LNG rod implants are equivalent to the six Norplant capsule implants with respect to safety and efficacy parameters, but permit easier and more rapid implant removal.

Adolescent↗
PubMed1994

Irregular bleeding, body mass index and coital frequency in Norplant contraceptive users.

Seventy-five women with a mean age of 27.5 years who requested Norplant implants for contraception were studied over a five-year period. The patients kept daily diaries of their vaginal bleeding and coital frequency, and were seen at least every six months at which time their weight was measured. This study examines the impact of Norplant implants use on menstrual regularity, body mass index and coital frequency. Irregular bleeding was most prevalent during the first two years of Norplant implants use and accounted for the primary reason for discontinuation of this method. No increase in Body Mass Index (BMI) was noted in Norplant implants users over the five-year study period. Women with irregular bleeding did not have a higher or lower BMI compared to women with regular bleeding and irregular bleeding patterns did not impact on coital frequency. Over five years, four pregnancies occurred during Norplant implant use. Norplant implants are a highly effective contraceptive method and women using this method should not expect an increase in body weight. Irregular bleeding is most frequent during the first two years of use and menstrual cyclicity resumes in the majority of women by the third year of use and continues to the fifth year of use.

Adult↗
PubMed1999

Efficacy, bleeding patterns, and side effects of a 1-year contraceptive vaginal ring.

A combined contraceptive vaginal ring designed to last 12 months was tested at three clinic sites. This ring released approximately 1 mg of norethindrone acetate (NET-Ac) and 20 micrograms of ethinyl estradiol (EE) daily. A total of 60 women were enrolled to use the ring in a schedule of 3 weeks in/1 week out. Serum norethindrone (NET) and ethinyl estradiol (EE) levels were assayed twice weekly in cycles 6, 9, and 13. Mean NET concentrations between cycles 6 and 9 were relatively stable between 13 and 19 nmol/L but showed a 10%-21% decrease in all centers between cycles 9 and 13. Mean EE concentrations ranged from 75 to 103 pmol/L, but did not have the same decrease as NET between cycles 9 and 13. Cycles with progesterone peaks (> 9.6 nmol/L) compatible with some luteal activity occurred in 4% of cycles sampled in Sydney, 3% in Santo Domingo, and 26% in Los Angeles. Half of these cycles exhibited at least one progesterone value > 32 nmol/L with three of 18 occurring in noncompliant cycles. Heavier body weight was associated with increased probability of luteal activity. Based on serum estradiol peaks > 400 pmol/L, eight of 81 cycles appeared to have marked follicular activity with no luteal activity. No pregnancies occurred. Nausea was reported by about half the subjects in approximately 10% of the visits (mainly in the first 1-2 days in the first cycle immediately after ring insertion). Vomiting was reported by 20% of subjects early in the first cycle only. Headache was reported on occasion by nearly 50% of the women, but the relationship to ring use was uncertain. Vaginal discharge was reported by 17 women (82% of these were from one clinic). Of 60 women, 14 discontinued before completing the study, but only two discontinuations were for medical reasons. Small but statistically significant changes occurred in lipid levels in two of the three centers. All changes remained within normal limits and were similar to those seen with many oral contraceptives. It appears that this ring may perform slightly differently in different populations, but is a highly satisfactory method of contraception for many women. Minor modifications in design could provide higher levels of steroid release and in the later months of the ring life span would assure continuing high levels of contraceptive protection for heavier women.

Adolescent↗
PubMedDate not supplied

International experience with NORPLANT and NORPLANT-2 contraceptives.

Experience encompassing more than 20,000 woman-years of use of NORPLANT capsules and 6,000 woman-years of trials of NORPLANT-2 rods is reviewed. Implant contraception repeatedly has been associated with low pregnancy rates and high continuation rates through five full years of use. Weight has proved to be a factor related to effectiveness. Women weighing less than 50 kg experienced cumulative five-year pregnancy rates well below 1 per 100, whereas the overall cumulative rate has been 3.5 per 100. Medical events reported during use that have led to discontinuation are analyzed from four large data sets.

Body Weight↗
PubMed1982

Influence of oral contraceptive therapy on the activity of systemic lupus erythematosus.

Since harmful effects of estrogens in murine lupus are well established, we studied the influence of oral contraceptive therapy on systemic lupus erythematosus activity in 26 female patients with lupus nephropathy. Combined preparations containing either 50 micrograms (14 patients) or 30 micrograms (7 patients) of ethinyl-estradiol were used in 21 courses in 20 patients. Initial manifestations or exacerbations of systemic lupus activity appeared within 3 months of beginning hormonal therapy in 9 patients, an overall incidence of lupus flare-up of 43%; there was major renal involvement in 4 patients. Conversely, evidence of lupus exacerbation did not develop in any of 11 patients who received pure progestogen oral contraceptive therapy with either continuous low-dose norsteroids (6 patients) or discontinuous progestogens at normal dosage (5 patients). These patients were followed for 5--30 months. Our data indicated that oral contraceptive therapy that used estrogens, even at low doses, often induced exacerbation of systemic lupus erythematosus activity. Pure progestogens, which were effective and devoid of such unfavorable effects, may be preferred in these patients.

Adolescent↗
PubMed1992

Risk factors inducing the persistence of high-risk genital papillomaviruses in the normal cervix.

To evaluate the risk factors associated with persistence of human papillomaviruses (HPV) types 16, 18, and 33 in the normal cervix, a prospective study was carried out in Belgium of 323 women without cytological evidence of cervical intraepithelial neoplasia. Demographic and clinical data were obtained by interview, and HPV DNA was assayed in cervical-swab specimens using the Fast Multiplex Polymerase Chain Reaction-based screening and confirmatory tests. A multivariable linear regression model was constructed using four well-known risk factors: the use of an oral contraceptive which is either triphasic, or monophasic and containing ethynylestradiol in association with either norethysterone, or levonorgestrel, or lynestrenol, or gestoden, or estrogenic and containing estriol (P = 8 x 10(-5)), a positive history of genital herpes simplex virus (HSV) infection (P = 10(-4)), an age inferior or equal to 30 years (P = 0.012), and cigarette smoking (P = 0.020). Crude and adjusted relative risks were calculated for each HPV persistence predictor. The data and the results of the molecular biology of high-risk genital HPVs are consistent with the hypothesis that the use of an oral contraceptive containing simultaneously and continuously both a potent estrogen and a high activity progestative is necessary to enhance significantly HPV transcription. These observations are also consistent with the hypothesis that the oral contraceptives and HSV genital infection are responsible for HPV persistence in the normal cervix but not for HPV-induced cervical transformation.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗
PubMed1975

Studies on the mechanism of action of continuous microdose quingestanol acetate.

The contraceptive mechanism of action of quingestanol acetate administered as a minipill was investigated in five healthy, ovulating women. Each woman served as her own control and was studied during a normal menstrual cycle followed by a cycle in which she received quingestanol acetate, 300 mug/day given orally beginning on cycle day 1, for 30 days. Urinary estrone, estradiol, estriol, total estrogens, pregnanediol; serum progesterone, follicle-stimulating hormone, and luteinizing hormone, together with cervical mucus properties (including viscosity, ferning, spinnbarkheit, cell content, pH, and proteins), sperm transport through mucus, vaginal cytology, and basal body temperature were studied serially during the control and study cycles. Endometrial biopsy specimens were obtained at the end of each cycle. The results indicated that all control cycles were ovulatory. In the treated cycles, endometrial morphology was slightly altered. There was also suppression of preovulatory follicle-stimulating hormone and luteinizing hormone peaks, alteration of urinary estrogens, and a decrease in serum progesterone during the luteal phase. Cervical mucus properties and sperm penetration were inhibited to varying degress during the treatment cycle. These findings suggested that at least three different factors, i.e., alteration of ovulation, disturbances of corpus luteum function, and cervical mucus changes causing inhibition of sperm penetration, were involved in the contraceptive mechanism of microdose quingestanol acetate.

Adult↗
PubMed1994

A comparative study of users of long-term contraceptive subdermal implants and female surgical contraception in Kenya.

This was a comparative study of users of Norplant contraceptive, Subdermal implants and LA Minilap, in rural, urban and peri-urban sites in Kenya during 1991-1993. Both methods are very well accepted by well counselled women seeking long-term, continuous, convenient, highly effective contraception. Norplant users had a mean age of 27.3 years, an average of 2.6 living children and 25.3 per cent were unmarried, while 32.9 percent had completed their families. This compares with 31.3 years, 6.2 living children, 0.6 percent unmarried and 100 percent completed families respectively for LA Minilap. Norplant acceptance rates have continued to rise over the few years since programme inception, and now stand at 5.4 percent of all new acceptors. LA Minilap acceptance trends shows a plateau or moderate down-turn at 21.6 percent of new acceptors. The possible reasons and implications of these observations, along with user characteristics are discussed.

Adolescent↗
PubMed2006

None of them were satisfactory: women's experiences with contraception.

Seventy-two women, aged between 18 and 50 years, participated in focus groups to talk about their experiences with using contraception. There were both continuities and differences between women in each of the age groups. Younger women appeared to be more accepting of medical opinion, while many older women rejected medical interference in contraceptive decisions. Patterns of use were similar with the pill having been the contraceptive of first choice for the majority of women. The most persistent feature through the groups was a strong sense of dissatisfaction with contraception, in terms of both side effects and range of available methods.

Adult↗
PubMed1984

Clinical experience with a triphasic oral contraceptive.

A triphasic combined oral contraceptive containing fluctuating amounts of ethinylestradiol and levonorgestrel was tested clinically in a multicenter trial at six hospitals in Norway. 367 women were included in the study, 3 588 cycles were studied, and the follow up period was 12 months. The one year continuation rate was 67%. Five pregnancies occurred during the study period. All of them had to be considered as patient failures. The causes for stopping medication were side effects in about 50% and the rest for personal reasons. The cycle control taking into account duration of bleeding, amount of flow, and intermenstrual bleeding was good and comparable to the low-dose monophasic combined pills. The incidence of side effects was low. One woman had an increase in systolic blood pressure to more than 140 mmHg. Thrombophlebitis was not registered. In conclusion the triphasic oral contraceptive was effective and had a good cycle control and low incidence of side effects.

Adult↗
PubMed2001

Biphasic versus monophasic oral contraceptives for contraception.

OBJECTIVES: To compare biphasic oral contraceptives with monophasic oral contraceptives in terms of efficacy, cycle control, and discontinuation due to side effects. Our a priori hypotheses were: (a) biphasic oral contraceptives are less effective in preventing pregnancy than are monophasic oral contraceptives, and (b) biphasic oral contraceptives cause more side effects, give poorer cycle control, and have lower continuation rates. SEARCH STRATEGY: We searched computerized databases MEDLINE, EMBASE, Popline and the Cochrane Controlled Trial Register. Additionally we searched the reference lists of all potentially relevant articles and book chapters. We also contacted the authors of relevant studies and pharmaceutical companies in Europe and the U.S. SELECTION CRITERIA: We included randomized controlled trials comparing any biphasic oral contraceptive with any monophasic oral contraceptive when used to prevent pregnancy. DATA COLLECTION AND ANALYSIS: We examined the studies found during the various literature searches for possible inclusion and assessed their methodological quality using the Cochrane guidelines. We contacted the authors of all included studies and of possibly randomized studies for supplemental information about the study methods and outcomes. We entered the data in RevMan 3.1, imported the data into RevMan 4.1, and calculated Peto odds ratios for the incidence of intermenstrual bleeding, absence of withdrawal bleeding, and study discontinuation due to intermenstrual bleeding. MAIN RESULTS: Only one trial of limited quality compared a biphasic and monophasic preparation. Percival-Smith et al. (1990) examined 533 user cycles of a biphasic pill (norethindrone 500 mcg/ethinyl estradiol 35 mcg for ten days, followed by norethindrone 1000 mcg/ethinyl estradiol 35 mcg for eleven days; Ortho 10/11) and 481 user cycles of a monophasic contraceptive pill (norethindrone acetate 1500 mcg/ethinyl estradiol 30 mcg daily; Loestrin). The study found no significant differences in intermenstrual bleeding, amenorrhea and study discontinuation due to intermenstrual bleeding between the biphasic and monophasic oral contraceptive pills. REVIEWER'S CONCLUSIONS: Conclusions are limited by the identification of only one trial, the methodological shortcomings of that trial, and the absence of data on accidental pregnancies. However, the trial found no important differences in bleeding patterns between the biphasic and monophasic preparations studied. Since no clear rationale exists for biphasic pills and since extensive evidence is available for monophasic pills, the latter are preferred.

Contraception↗