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PubMed1989

A comparative analysis of three different dose combinations of oral contraceptives.

Three different low-dose formulations of oral contraceptives were compared to determine the most suitable preparation for Filipino women as reflected in the first year continuation rates, incidence of side effects and failure rates. A total of 1,800 subjects were enrolled in the study from 18 health centers in six provinces in two regions of the Philippines, covering a total of 18,282 women-months of use. Sociodemographic characteristics were comparable. The monophasic levonorgestrel group showed the best performance followed by the triphasic preparation. The norethindrone group consistently showed higher drop-out rates, which may be due to the relatively higher incidence of side effects. For all three preparations, bleeding irregularities were low. There were no major side effects and no pregnancy was reported in one year of use. Noted was a distinct regional and provincial difference in recruitment and follow-up performance, possibly due to clinic, client or program factors.

Adult↗
PubMed2003

Estimating and comparing correct-use failure probabilities in clinical studies of condom functionality.

In a clinical study comparing the failure probabilities of two condom types, the sample of all reported acts of intercourse in which a study condom was used by a randomized participant is typically defined to be the primary analysis sample. However, it may also be desirable to make comparisons among only those acts in which the participants correctly followed all condom use instructions before, during, and after the act of intercourse (i.e., the "correct-use" subset). The timing associated with the definition of correct use creates a dilemma in that an act cannot be classified as a "correct-use act" until after the completion of both intercourse and withdrawal; if a condom fails (e.g., breaks or slips completely off of the penis) during intercourse then the couple has no chance at correct use during withdrawal. As a result of the implicitly conditional nature of this problem, it is not a simple matter to specify a correct-use subset of the primary analysis sample. With this in mind, we develop estimators for the correct-use failure probabilities, the corresponding standard errors, and test statistics for comparing the correct-use failure probabilities between condom groups. We demonstrate the utility of the proposed methods by applying them to data from a clinical study of condom contraceptive effectiveness, and we use simulated data to investigate the finite sample properties of the proposed methods. The simulation results indicate that one of our proposed estimators is at least approximately unbiased, even in small samples. Furthermore, one-sided noninferiority tests performed using this estimator tend to have sizes that are only marginally larger than the nominal test size in moderate to large samples.

Computer Simulation↗
PubMed1996

The Yuzpe regimen of emergency contraception: how long after the morning after?

OBJECTIVE: To determine whether failure of the Yuzpe method of emergency contraception (which involves taking a higher than usual dose of ordinary combined oral contraceptives within 72 hours after unprotected intercourse, with a second dose taken 12 hours later) depends on the interval between intercourse and treatment. DATA SOURCES: We searched the literature for studies in which investigators separately reported both the number of women treated with the Yuzpe regimen and the resulting pregnancies when treatment was started on the first, second, and third days after unprotected intercourse. Searches of the electronic data bases MEDLINE, POPLINE, EMBASE, and BIOSIS were supplemented by scrutiny of the bibliographies of all papers identified through the electronic search. METHODS OF STUDY SELECTION: We identified nine published studies that present the number of women treated and outcome of treatment by time since unprotected intercourse. We included all nine studies in our analysis. TABULATION, INTEGRATION, AND RESULTS: Differences in failure rates by time of treatment adjusted for study-site effects were analyzed using logistic regression. We found no significant differences in failure rates when therapy was started on the first, second, or third day after unprotected intercourse. The large sample size ensured a power of 76% to reject the null hypothesis of equal failure rates when the odds of failure on the third day are twice those on the first and second days. CONCLUSION: Our results have two clinical implications. First, insistence on taking the first dose as soon as possible may be counterproductive in circumstances when taking the second dose 12 hours later would be difficult. Second, clinical protocols that deny treatment after 72 hours may be excessively restrictive, particularly if the alternative of emergency insertion of a copper intrauterine device is not immediately available or appropriate.

Clinical Trials as Topic↗
PubMedDate not supplied

Evaluation of the efficacy of a polyurethane condom: results from a randomized, controlled clinical trial.

CONTEXT: Condoms made of latex are not comfortable or appropriate for all consumers. Polyurethane condoms may provide a needed alternative. METHODS: In a double-masked study, 805 monogamous couples were randomized to use either the polyurethane condom or the latex condom for six months. Couples recorded the frequency of intercourse, of condom use and of breakage and slippage throughout the trial in coital diaries and in detailed reports on the first five uses. Breakage and slippage rates were determined, and typical-use and consistent-use pregnancy rates were calculated using life-table analysis, adjusted for use of emergency contraception. RESULTS: The six-month pregnancy rate during typical use (adjusted for use of emergency contraception) was 4.8% for the polyurethane condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during consistent use over six completed menstrual cycles--2.4% for the polyurethane condom and 1.1% for the latex condom--did not differ significantly. Clinical failure rates (including breakage and slippage occurring during either intercourse or withdrawal) were 8.5% for the polyurethane condom and 1.6% for the latex condom. In general, male participants were more satisfied with the latex condom, and users of latex were significantly less likely to drop out of the study for condom-related reasons than were users of polyurethane. CONCLUSIONS: Although polyurethane and latex condoms provide equivalent levels of contraceptive protection, the polyurethane condom's higher frequency of breakage and slippage suggests that this condom may confer less protection from sexually transmitted infections than does the latex condom.

Condoms↗
PubMed2005

Prevalence of sexual activity and family-planning use among undergraduates in Southwest Nigeria.

OBJECTIVE: To assess the prevalence of sexual activity and family-planning use among undergraduates in a private tertiary institution in Nigeria. METHODS: A cross-sectional survey of 283 undergraduate students. RESULTS: Out of 283 students, 245 (86.6%) are sexually active in the last month. Out of these 245, 219 (89%) are currently using a family-planning method. In the study population, the percentages of awareness, ever use, and current users are 89%, 77%, and 75%, respectively. The most commonly known, ever used, and currently used contraceptive is condom followed in descending order by calendar method, oral pills, coitus interruptus, injectable contraception, emergency contraception, intrauterine contraceptive device, and diaphragm. Unmarried students and male gender show statistical significance with condom use. The reasons for preferring the current contraceptive method, among 219 current users, include safety, cost, ready availability, and partner's preference, among others. Most of the nonusers gave no reason for a failure to use a contraceptive, but others felt that contraceptives are dangerous, while a minority were ignorant of any method. Though many use a condom, this use is inconsistent. CONCLUSION: There is a high level of sexual activity among these undergraduates. Many are aware of family planning, and the condom is the most commonly known and used method, though not consistently. Reproductive-health education should be promoted among youths in Nigeria.

Adult↗
PubMedDate not supplied

Nonoxynol-9 vaginal pessary: a preliminary Indian experience.

BACKGROUND: Barrier methods of contraception do not have systemic effects and allow the user complete control over their use. For women, the ease of use of a contraceptive is often more important than its efficacy. Hence, barrier methods could be offered as a useful alternative method of contraception. Nonoxynol-9 (a spermicide) is a locally acting, non-hormonal method free from systemic side-efforts. It is a woman-controlled, reversible method which is to be used before intercourse. There are little data available on its efficacy, side-effects and acceptability among Indian women. METHODS: The vaginal pessary nonoxynol-9 was offered as a contraceptive option to 3200 women attending the Family Planning clinics at 31 Human Reproduction Research Centres (HRRCs) of the Indian Council of Medical Research. The other contraceptives offered included an intrauterine device, oral pills, condoms, Norplant, tubal sterilization and vasectomy using the cafeteria approach. Those who accepted nonoxynol-9 were followed up to assess the rates of continuation, failure and side-effects. RESULTS: The nonoxynol-9 pessary was accepted by 541 women who were followed up for 3470 woman-months of use. The reasons given for acceptance were that it was user-controlled and/or they did not wish to use other methods because of the side-effects or contraindications of these methods. The overall continuation rates were 41.2% and 33% at 9 and 12 months of use, respectively. Most women (31.3%) discontinued its use due to personal reasons such as husband dissatisfaction, desire for further pregnancy, irregular use of pessary and difficulty in insertion. Twenty-nine women became pregnant during the study period (15 due to method failure and 14 due to user failure) giving a use-effectiveness of 8.8% at 12 months. The method failure rate was 4.3% at 12 months of use. The failure rates were lower compared with the reported failure rates of barrier contraceptives (1%-30% at 1 year of use) and the side-effects were minimal. CONCLUSION: Nonoxynol-9 had low acceptability (16.9%) and overall continuation rates--41.2% and 33% at 9 and 12 months of use. It could be offered to women looking for a short term, user-controlled contraceptive.

Adolescent↗
PubMed1990

The long-term outcome following "special clearance" after vasectomy.

Between 1980 and 1985, 6067 out-patient vasectomies were performed under local anaesthesia at the Elliot Smith Clinic in Oxford. During this period 151 men (2.5%) were given a "special clearance". This sanctioned the discontinuation of other forms of contraception despite the persistence of scanty (less than 10,000/ml) sperm in 2 consecutively examined semen samples at least 7 months after vasectomy. These men have been reviewed and further specimens of semen requested after a minimum follow-up of 3 years (range 3-8); 50 patients supplied a specimen and all except 1 were azoospermic. No pregnancies attributable to failure of the vasectomy have been identified.

Adult↗
PubMed1993

Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol.

OBJECTIVE: To compare two oral contraceptive pills, both containing 150 micrograms desogestrel, but with either 20 micrograms (Mercilon) or 30 micrograms (Marvelon/Desolett) ethinyl oestradiol (EE), regarding reliability, cycle control and side effect profile. DESIGN: A double blind, randomised, multicentre study over one year with follow up after three, six and 12 months. The women noted tablet intake and all bleedings on specifically designed diary cards. SETTING: University clinics, central hospitals and private gynaecological practices in Norway, Sweden and Denmark. SUBJECTS: One thousand women aged 18 to 40 years requesting oral contraceptive pills. MAIN OUTCOME MEASURES: Reliability, cycle control, side effects, blood pressure, body weight and haemoglobin. RESULTS: In a total of 4543 cycles with the 20 micrograms EE dose pill and 4688 cycles with the 30 micrograms EE dose pill, the number of pregnancies ascribed to method failure were 0 and 2, respectively. Irregular bleeding (break-through bleeding or spotting) was significantly more frequent with the 150/20 combination in about two-thirds of the cycles randomly distributed over the one year of the study. Mean blood pressure decreased slightly, particularly in the group on the 150/20 combination (about 1 mmHg), whereas mean body weight increased approximately 0.5 kg in the group with the 150/30 combination after 12 months. Haemoglobin did not change. Side effects other than bleeding problems were rare, but dizziness and mood changes were more frequent in the group on the 150/20 combination. Due to side effects, more women on the 150/20 combination discontinued the study during the one to three and four to six month periods, and women on this pill were also less positive about continuing the study drug at the end of the trial. CONCLUSIONS: Both pills have high contraceptive reliability and are well tolerated, but with the 150/20 combination the cycle control is less effective. However, in view of the potentially increased safety profile of the 150/20 combination, many women can be expected to accept some additional discomfort due to irregular bleeding.

Adolescent↗
PubMed1991

An evaluation of the Bioself 110 electronic fertility indicator as a contraceptive aid.

The Bioself 110 is a hand-held electronic device that combines the BBT and calendar methods of fertility regulation for planning or preventing pregnancy. A pilot study was undertaken in three centers in the United Kingdom to evaluate the Bioself 110 as a contraceptive aid. This paper deals with 1238 cycles from 131 women. Only one unplanned pregnancy occurred where a volunteer correctly used the Bioself 110 and had intercourse on a supposedly "safe" day. A second pregnancy was experienced by a volunteer who incorrectly used the device and had intercourse on what she though was a "safe" day. Another 11 unplanned pregnancies occurred due to barrier method failures, as well as 11 pregnancies where the volunteers knowingly had unprotected intercourse during the fertile phase. There were five planned pregnancies. The Bioself 110 was correctly used in 71% of the cycles studied. Eighty-four percent of the volunteers indicated that they were satisfied with the Bioself 110 after six to twelve cycles of use. It was concluded that the Bioself 110 can serve as an effective family planning aid and should be added to the menu of contraceptive methods available to women today.

Adolescent↗
PubMed1997

Factors influencing the reliability of oral contraceptives.

BACKGROUND: The reliability of oral contraceptives (OC) is high but several known factors can potentially induce failures. The dose of estrogen (EE) has been reduced through the years. Interaction with concomitant use of other medicine is wellknown and gastroenteritis can reduce the uptake of EE. To further characterize and quantify these factors we have performed this study. METHODS: Among patients admitted for legal abortion we selected those who had taken OC (only combined preparations; gestagen-only preparations were excluded) according to the prescription but nevertheless became pregnant. Various parameters were noted. RESULTS: Among 8058 women 70 women were found. Twenty-nine used three-phased and 25 used low-dose OC while the rest used high-dose, two-phased or unknown OC (four, five and seven patients respectively). Five patients used other medicine concurrently (salbutamol, astemizol, mianserin, chlorcyclizin, paradryl, carbamazepin, lithium, chlorprotoxin and imipramin). Sixteen patients had symptoms of gastroenteritis at the time of conception. Forty-nine patients had failure without any known influencing factors. There was no significant difference between the various OC used by the patients compared to sales of them in Denmark. About two-thirds of the patients wanted to continue with OC as future prevention. CONCLUSIONS: Failure of OC is a rare event but can occur in case of concurrent gastroenteritis or use of other medicine but in many cases, however, no definite cause can be determined. The EE-content of the various OC was not found to have any influence. Although OC-failure had occurred two-thirds of the patients wanted to continue the use of OC.

Adolescent↗
PubMed1991

A comparative study of 35 mcg and 50 mcg combined oral contraceptives: results from a multicenter clinical trial.

A comparative multicenter clinical trial of two combined oral contraceptives (OCs) differing only in the estrogen content (35 mcg ethinyl estradiol versus 50 mcg mestranol) was conducted at five clinics located in Yugoslavia, Egypt, Sri Lanka, Costa Rica and Mexico. The trial was designed to determine the differences between Norinyl 1+35 (Syntex) and Norinyl 1+50 (Syntex) in rates and reasons of discontinuation, and frequency of selected side effects which might contribute to method discontinuation. This report includes analysis of 1698 women, all of whom were interval patients (at least 42 days but within 26 weeks postpartum), randomly allocated to one of the above OCs between October 1982 and January 1984. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Significantly more women in the Norinyl 1+35 group (p less than .001) reported intermenstrual bleeding (primarily staining and spotting), as well as an increase in the occurrence of intermenstrual bleeding compared to women in the Norinyl 1+50 group. There were no significant differences between the groups for side effects with the exception of more women in the Norinyl 1+50 group (p less than .05) reporting breast discomfort. The lost to follow-up rate at 12 months was 19.3% for both the Norinyl 1+35 and the Norinyl 1+50 groups. The total discontinuation rate (including women lost to follow-up) at 12 months was 43.5% for the Norinyl 1+35 group and 41.0% for the Norinyl 1+50 group. There were no significant differences between the two groups for gross cumulative life table discontinuation rates (p greater than .05). There were six accidental pregnancies attributed to user failure reported during the study period; four in the Norinyl 1+35 group and two in the Norinyl 1+50 group.

Adult↗
PubMed1993

Phase III clinical trial with Norplant II (two covered rods): report on five years of use.

The subdermal implant NORPLANT II contraceptive was studied for its safety, efficacy and acceptability over a period of 5 years of use in a phase III multicentre clinical trial. A total of 1,466 women were observed for 52,849 women-months of use. Only four pregnancies were reported during the study period, giving a method failure rate of 0.8 per 100 users at 5 years of use. The continuation rates were 61.4, 49.0 and 42.1 per 100 users at 3, 4 and 5 years of use, respectively. The majority of the discontinuations were due to bleeding irregularities which accounted for 22.2, 26.3 and 28.5 per 100 users at 3, 4 and 5 years of use, respectively. The next common reason was planning pregnancy which was observed mainly in women having one child. The discontinuations due to infection, expulsion or displacement of device were very low (0.2-0.3 per 100 users). Due to vigorous efforts made by the centers to follow the subjects, the lost-to-follow-up rate was very low (1.6% at 5 yr).

Adolescent↗
PubMed1989

Mini-pill in lactating women.

A non-comparative study of the progestogen-only oral contraceptive, norgestrel 0.075 mg, in breast-feeding women was conducted at the Centro de Investigaciones Regionales, Merida, Yucatan, Mexico. The study was designed to evaluate the overall acceptability and contraceptive efficacy of norgestrel in breast-feeding women. This report includes a survey of 200 women, all of whom were less than 26 weeks postpartum at admission; 113 were interval patients and 87 were postpartum. Follow-up visits were scheduled at 2, 6 and 12 months after admission. Overall, women experienced an increase in intermenstrual bleeding, amenorrhea, vaginal discharge and breast discomfort. The discontinuation rate at 12 months was 32.5 and the corresponding lost to follow-up rate was 22.5; this is a measure of acceptability. The 12-month life-table rate for pregnancy was 3.4 with a standard error of 2.0. Three women discontinued use of the mini-pill due to accidental pregnancy. One pregnancy was attributed to user failure and the woman conceived 9 months after entering into the study; the other two were attributed to method failure, one woman conceived 3 months after admission and the other conceived 6 months after admission.

Adult↗
PubMed1983

Tubal sterilization: findings in a large prospective study.

Of the 17032 women taking part in a large prospective study of the beneficial and harmful effects of different contraceptive methods, 2243 (13%) had undergone tubal sterilization by the end of 1981 while another 3551 (21%) had husbands who had undergone vasectomy. The most commonly used female sterilization procedure was laparoscopic tubal diathermy. About 19% of all operations were carried out at the time of a delivery or during the subsequent 4 weeks. In total, 16 accidental pregnancies have occurred in the sterilized women, the failure rate during the 12 months after surgery being 0.37 per 100 woman-years and the rate during the subsequent months being 0.10 per 100 woman-years. Of the 16 accidental pregnancies, seven were ectopic. In an analysis comparing women who had undergone tubal sterilization with those whose husbands had undergone vasectomy, there was little evidence of any excess occurrence of gynaecological or psychiatric disorders in the former group.

Adult↗
PubMed1981

[Intrauterine contraception with copper-T 200 device- a retrospective analysis of 334 cases (author's transl)].

A review is given of the findings obtained in 334 women in whom a Cu-T 200 intrauterine device had been inserted at least two years previously and regular follow-up examinations were subsequently undertaken. The most frequent indications were an expressed preference for IUD on the patient's part (38.3%), poor tolerance to the "pill" (24.8%) and so-called "pill fatigue" (11.1%). Varicose veins led to IUD preference in 8.1% and thromboembolic disease in 6.-%. The failure rate - with 12 pregnancies - was 3.6%, all within 6 months of insertion of the device. Half of the pregnancies went to full term and resulted in the birth of mature, healthy babies. The most frequent complication were menstrual disturbances (20.1%). pain (19.5%), cervicitis (18.3%), and adnexitis (13.8%), necessitating removal of the device in 5.7%, 4.2%, 5.1%, and 0.6% of all cases for the afore-mentioned reasons, respectively. These rates are relatively high. The expulsion rate of 2.7% was relatively low, however. Further analysis of the complications led to the observation that menorrhagia was relatively common in nulliparae and in women with retroversion of the uterus, whereas the pre-insertion finding of a pressure-sensitive uterus with a normal ESR, led in a significantly higher percentage of cases to pain and adnexitis. The diagnosis by vaginal probe of a reduced uterine length led to faulty positioning and an increased tendency to pain in a significantly higher number of cases. The fact that only 56.6% of all women tolerated intrauterine contraception well and remained totally symptom-free supports th view held by us that even today the "pill" remains the contraceptive of choice and should be recommended as such.

Female↗
PubMed1994

Effect of mifepristone on inhibition of ovulation and induction of luteolysis.

Mifepristone administration to women in the mid- or late follicular phase delays the luteinizing hormone (LH) surge and prolongs the follicular phase. Since the resumption of follicular growth commences following mifepristone cessation, the drug must be given either continuously or at repeated intervals in order to block ovulation. Using various regimens with or without exogenous progestins, ovulation was inhibited in the majority of subjects. However, this was not consistent and in several instances, LH surges and a rise in plasma progesterone were suggestive of ovulation and corpus luteum function. Therefore, mifepristone cannot be used as a contraceptive which will reliably inhibit ovulation. With low-dose mifepristone administration, alterations in endometrial morphology were characterized by a delay in maturation despite the presence of ovulation. This suggests that the endometrium displays a greater sensitivity to mifepristone than does the pituitary, a finding that may have important contraceptive implications. Late luteal-phase mifepristone administration to women who were not sexually active did not alter their menstrual rhythm, bleeding patterns or steroid and gonadotrophin concentrations. However, when used in unprotected women in the late luteal phase, mifepristone did not uniformly terminate all pregnancies. On the other hand, when used within 72 h of intercourse, mifepristone was as effective a post-coital agent as the standard high-dose oestrogen-progestin combination.

Abortion, Induced↗
PubMed1992

Mifepristone (RU 486) compared with high-dose estrogen and progestogen for emergency postcoital contraception.

BACKGROUND: Mifepristone (RU 486) is a synthetic steroid with potent antiprogestational and antiglucocorticoid properties that provides an effective medical method of inducing abortion in early pregnancy. Since progesterone is essential for implantation, we tested the use of mifepristone for emergency postcoital contraception. METHODS: We studied 800 women and adolescents requesting emergency postcoital contraception who had had unprotected intercourse within the preceding 72 hours. A total of 398 women and adolescents were randomly assigned to treatment with 100 micrograms of ethinyl estradiol and 1 mg of norgestrel, each given twice 12 hours apart (standard therapy), and 402 women and adolescents were randomly assigned to receive 600 mg of mifepristone. RESULTS: None of the women and adolescents who received mifepristone became pregnant, as compared with four of those who received standard therapy; the difference in failure rates between the two regimens was not statistically significant. The number of pregnancies in each group was significantly lower than the number expected according to calculations based on the day of the cycle during which intercourse had taken place (P less than 0.001). In many subjects the stage of the cycle as calculated by menstrual history was inconsistent with measurements of plasma progesterone or urinary pregnanediol excretion. The subjects treated with mifepristone reported less nausea (40 percent vs. 60 percent) and vomiting (3 percent vs. 17 percent) on the day of treatment, as well as lower rates of other side effects, than the subjects treated with the standard regimen, but they were more likely to have a delay in the onset of the next menstrual period (42 percent vs. 13 percent). CONCLUSIONS: Mifepristone is a highly effective postcoital contraceptive agent that, if used more widely, could help reduce the number of unplanned and unwanted pregnancies.

Adolescent↗