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PubMed1988

Non-availability of the IUD and contraceptive choice.

The Copper 7 and Lippes Loop IUD are no longer distributed in the United States, and the cost of the Progestasert precludes usage in many family planning clinics. The impact of the loss of this widely used contraceptive method was assessed in a pilot study at the UCLA Family Planning Clinic. The clients who would have selected an IUD at the time of their clinic visit between March and December of 1986 instead chose oral contraceptive pills (55%) or barrier methods (45%) but their level of dissatisfaction with the methods they received was significantly greater than that of all other contraceptors, and this led to their subsequent selection of another method which, in the majority (66%), was of lower efficacy than the IUD. There were two unplanned conceptions amongst twenty women who would have chosen an IUD, both due to non-compliance with oral contraceptive pills; and at the time of survey in March 1987, no clients had opted for sterilization. Women who no longer have their choice of the IUD represent a high risk for contraceptive dissatisfaction and failure, but have not made precipitous decisions to undergo permanent sterilization.

Adolescent↗
PubMed1988

A comparative clinical trial of Norinyl 1/35 versus Brevicon in Rio Clara, Brazil.

A comparative clinical trial of two combined oral contraceptives (OCs) with equivalent estrogen content, but different amounts of progestogens, was conducted at the Centro Medico Especializado em Planejamento Familiar in Rio Clara, Brazil. The study was designed to determine the differences in discontinuation rates between Norinyl 1/35 (Syntex) and Brevicon (Syntex) as well as the frequency of selected side effects which might contribute to method discontinuation. Both OCs contain 0.035 mg of ethinyl estradiol; Brevicon contains 0.5 mg and Norinyl 1/35 contains 1 mg norethindrone. Three-hundred women enrolled in the study were randomly assigned to either the Norinyl 1/35 or Brevicon OCs and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Intermenstrual bleeding was reported by significantly more women in the Brevicon group than in the Norinyl group (p less than 0.05), and significantly more Brevicon users reported an increase in intermenstrual bleeding. At the end of the study period, no differences were found between the two OC groups in terms of discontinuation rates, but a large number of women in each group discontinued for menstrual problems. The total discontinuation rates at 11 months for both groups were extremely high: 68.2 for the Norinyl 1/35 group and 75.2 for the Brevicon users. The largest group of discontinuations were comprised of those discontinuing for menstrual problems, other personal reasons, planned pregnancy and side effects.

Adult↗
PubMed1989

Cancer of the breast and reproductive tract in relation to use of oral contraceptives.

Effects of oral contraception on cancers of the female breast and reproductive tract are critically reviewed from human studies reported since 1980. The cumulative risk of breast cancer through 59 years of age appears to bear no relationship to oral contraceptive (OC) use whatsoever. Studies restricted to women under age 45, however, raise concern about a possible adverse effect from OC use before a first-term pregnancy. A duration-related protective effect against endometrial cancer occurs from use of combined OCs. The risk is reduced by about 40% with 2 years of use, and by about 60% with 4 or more years of oral contraception. Oral contraception in excess of 3 years protects against ovarian cancer. Four years of use confers a 50% reduction in risk and 7 or more years of use confers a 60%-80% reduction in ovarian cancer risk. Studies of cervical dysplasia and carcinoma in situ suggest elevated risks with 2 or more years of OC use, although results are difficult to interpret in view of numerous factors that might distort the findings. The risk of invasive cervical cancer appear to be unaffected by up to 5 years of oral contraception. Beyond this, there is evidence suggesting an elevated risk which approaches a 2-fold increase at 10 years of use. Cancers of the vagina and fallopian tube are extremely rare. Their risks have yet to be characterized in relation to oral contraception.

Adolescent↗
PubMed1989

Clinical evaluation of two monthly injectable contraceptives and their effects on some metabolic parameters.

One-hundred-and-thirty normally menstruating females were subgrouped equally and enrolled from the family planning clinic to study the clinical performance of the monthly injectable contraceptives medroxyprogesterone acetate 25 mg + estradiol cypionate 5 mg (Cycloprovera) and norethisterone enanthate 50 mg + estradiol valerate 5 mg (HRP-102) and their effects on some metabolic parameters. The contraceptive efficacy after 6 months of use for both drugs was 100%. No change in menstrual pattern occurred in 74% of Cycloprovera users and 67.3% of HRP-102 users. A statistically significant decrease (P less than 0.01) occurred in HDL-cholesterol and total serum protein values and a statistically significant increase (P less than 0.01) was observed in hematocrit value of Cycloprovera users only. Body weight and blood pressure values after 6 months of drug use showed no statistically significant changes in both groups. Also, no statistically significant changes were noticed in both groups for hemoglobin, post-prandial blood glucose, cholesterol, A/G ratio, SGPT and SGPT values following 6 months of injectable contraceptive use. None of the injectable users developed cervical dysplastic changes cytologically.

Alanine Transaminase↗
PubMed1989

The contraceptive sponge: factors in initiation and discontinuation of use.

This study examined characteristic of the contraceptive sponge that were important in women's decisions to use the contraceptive sponge and reasons why women discontinued sponge use. A sample of 385 current sponge users and 407 former sponge users participated in a national telephone survey on sponge use. Important reasons for trying the sponge were effectiveness, comfort, convenience and ease of use and it "would not interfere with sexual pleasure." The media and physicians were of considerable influence in women's decisions to initiate sponge use, but sexual partners, friends, parents and relatives exerted little influence. The most important reasons for discontinuing use of the sponge were pregnancy, both planned and accidental, and irritation, discomfort or vaginal infection. Women may decide to use the sponge because they have unrealistically positive perceptions of sponge characteristics.

Adolescent↗
PubMed1989

The effects of a progestin-only oral contraceptive (levonorgestrel 0.03 mg) on breast-feeding.

This study was a non-randomized clinical trial which compared the breast-feeding experience of 250 Argentine women taking levonorgestrel 0.03 mg daily (begun one week after delivery) with that of 250 women using non-hormonal contraceptives. Weight gain of unsupplemented infants, the most important of the several criteria used to assess breast-feeding performance, was similar for the two contraceptive groups. Levonorgestrel users began supplementary feeding of their infants significantly later than did non-hormonal users; levonorgestrel users were also somewhat less likely to discontinue breast-feeding during the study period. The two contraceptive groups were similar with regard to several other measures of breast-feeding performance: growth of all infants (regardless of supplementation), patterns of contraceptive discontinuation, mothers' subjective impressions of breast-milk sufficiency, and comparison of supplementation initiation with previous experience.

Adult↗
PubMed1989

A study of the vaginal contraceptive sponge used with and without the fertility awareness method.

The actual effectiveness rates of natural and barrier methods of family planning are lower than the theoretical ones. If couples accurately defined the limits of the fertile phase and used barriers at that time, then actual effectiveness might increase. A randomized, controlled clinical trial was initiated to determine the effectiveness of the contraceptive sponge used only during the fertile time and to compare this with sponge use at every intercourse. Recruitment problems and discontinuation forced the early termination of this study, but qualitative information about compliance and acceptability was collected. Common sponge problems were reported as were misuses of the sponge, but problems and misuse were not related. Determination of the fertile phase was reportedly easy, but complaints of and discontinuation for inconvenience occurred. For unplanned pregnancies, contraceptive behaviors around the time of conception are presented.

Adolescent↗
PubMed1991

Oral contraceptives and neoplasia of the ovary.

Epidemiologic literature on oral contraceptives in relation to primary ovarian cancer is reviewed. Compared to women who have never used oral contraceptives, women who have ever taken oral contraceptives have about a 30% reduction in risk for epithelial ovarian cancer, and five or more years of use is associated with a 50% reduction in risk. The protective effect of oral contraceptives persists for ten or more years after use is discontinued, and becomes apparent several years after beginning use. Effects of oral contraceptives are similar for malignant and borderline malignant epithelial ovarian cancer. Reduced risks among oral contraceptive users have been observed for all major histologic subtypes of epithelial ovarian cancer, and for women from developed and developing countries. Risk estimates for epithelial ovarian cancer in relation to oral contraceptive use stratified by age at diagnosis or parity are not uniform across studies. No consistent protective effect is apparent for non-epithelial ovarian tumors or benign ovarian tumors, including teratomas and cystadenomas, although limited data are available on the relationship between oral contraceptives and these neoplasms. Several areas for future research are described.

Contraceptives, Oral↗
PubMed1991

The efficacy and acceptability of a low-dose levonorgestrel intravaginal ring for contraception in a UK cohort.

The efficacy and acceptability of a levonorgestrel-releasing intravaginal ring (IVR) for contraception was assessed in a British cohort studied as part of a multicentre, multinational clinical trial performed under the auspices of the World Health Organisation. One-hundred-and-fifty women took part in the study in two UK centres and completed 1417.5 months of method use. Fifty-nine women discontinued use of the IVR before the end of one year giving an overall discontinuation rate of 39.9 per 100 woman-years. The discontinuation for pregnancy with the ring in situ, was 3.0 per 100 woman-years (life table analysis). Menstrual disturbance, vaginal problems and involuntary expulsion resulted in discontinuation rates of 8.9, 8.4 and 1.6 per 100 woman-years, respectively. This method is an acceptable and effective method of contraception for women.

Adolescent↗
PubMed1991

An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs.

The levonorgestrel-releasing IUD (LNG-IUD-20), providing a daily dose of 20 ug, has recently been approved for marketing in Finland. The IUD's high efficacy in preventing accidental pregnancy and other numerous positive features make it a promising contraceptive device for worldwide use, just like the currently available T-shaped copper-releasing (TCu) IUDs. This paper reviews published reports comparing the LNG-IUD-20 and the currently used TCu IUDs. The merits and disadvantages of the steroid-releasing IUD are evaluated in terms of its performance and other special features relative to the TCu IUDs. Also, a number of future studies with medical and programmatic importance are proposed. A broader understanding about these two IUD families will facilitate their use in a complementary way for family planning programs.

Drug Evaluation↗
PubMed1992

Postpartum IUDS: keys for success.

Intrauterine device (IUD) insertion is convenient and efficient in the postplacental and immediate postpartum periods. Insertion at these times is demonstrably safe, having a low incidence of infection, few bleeding problems, and low perforation rates. IUD expulsion rates can vary widely, and are a function of timing of insertion, type of IUD, and insertion technique. When a copper T device is inserted postplacentally or immediately postpartum by an experienced and trained clinician, expulsion rates of about 7-15 per 100 users at six months can be expected. Women must be told how to detect expulsions and instructed to return for reinsertion or for another method. Most investigators emphasize that high fundal IUD placement will reduce the expulsion rate. Unplanned pregnancy rates for postplacental IUD insertion range from 2.0-2.8 per 100 users at 24 months when using modern copper IUDs, correct insertion technique, careful postinsertion instructions and good follow-up. Postplacental insertions are performed manually or with a ring forceps. Immediate postpartum insertions (10 minutes to 48 hours after delivery) are performed with the ring forceps.

Contraception↗
PubMed1993

A multicenter comparative trial of triphasic and monophasic, low-dose combined oral contraceptives.

A comparative multicenter clinical trial of two combined oral contraceptives (OCs) was conducted at clinics located in the Sudan, Sri Lanka, Chile, the Dominican Republic and Ecuador. The trial was designed to determine if there were differences in efficacy, safety and acceptability between a triphasic and a low-dose monophasic OC. This report includes analysis of 1088 women. At each center, subjects were randomly allocated to one of the two OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. There were two accidental pregnancies attributed to user failure reported during the study period; one in the triphasic group and one in the monophasic group. Adverse experiences were mainly minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. Cycle control was good in both groups with women in the triphasic group reporting fewer complaints of intermenstrual bleeding. Both OCs were safe and effective.

Adolescent↗
PubMed1993

A preliminary report of Norplant implant insertions in a large urban family planning program.

During the 21-month period between August 1, 1991, and April 30, 1993, 2,358 women received Norplant system insertions in either Parkland Memorial Hospital or the Dallas Maternal Health and Family Planning clinics. Forty-three percent of these women were teenagers with 14% 16 years of age or less. Overall, 431 patients received Norplant implants insertions postpartum prior to discharge from the hospital. To date, 138 Norplant systems have been removed, with the proportion of contraceptive implant removals among teenagers being essentially the same as that in more mature women. Of the reasons given by women discontinuing the Norplant system, an unanticipated high incidence of pain in the arm containing the implants, hair loss, and mood changes were noted. We have found the Norplant system to be a highly effective and highly acceptable contraceptive method for a large number of indigent women.

Adolescent↗
PubMed1994

An analysis of the personal reasons for discontinuing IUD use.

The objective of this study was to evaluate possible factors associated with discontinuing use of TCu 380A IUDs due to personal reasons among 2748 users. Overall, a total of 88 subjects discontinued using the TCu 380A IUD within 12 months postinsertion for personal reasons. The most common reasons were planned pregnancy (32%) and husband or family opinion against IUD use (26%). The gross cumulative 12-month life table discontinuation rate for all personal reasons was 4.0 per 100 women. Having no education and/or living in a rural area were the sociodemographic characteristics associated with an increased risk of discontinuation for personal reasons. Effective and regular counseling about IUD use, especially among illiterate women, may help prevent IUD discontinuations related to personal reasons.

Attitude↗
PubMed1994

Vaginal bleeding patterns in women using once-a-month injectable contraceptives.

The main raison d'être for the development of once-a-month injectable contraceptives is the need for a long-acting method which produces a regular vaginal bleeding pattern. Although many women will successfully tolerate the amenorrhea or irregular bleeding which frequently accompany use of long-acting progestogen-only methods, there is a substantial minority, especially in certain ethnic groups, who find this unacceptable. The extensive literature does indicate that although combined estrogen-progestogen once-a-month injectables produce much more regular bleeding patterns than long-acting injectables like depot-medroxyprogesterone acetate, the patterns are not entirely normal. Detailed studies by the World Health Organization have demonstrated some deviation from normal menstrual patterns by users of the two once-a-month injectables, Cyclofem and Mesigyna. For example, 23.5% of Cyclofem and 25.2% of Mesigyna users experience irregular bleeding between 3 and 6 months of use compared with 4.8% of untreated women, and 13.3% of Cyclofem and 11.1% of Mesigyna users experience prolonged bleeding compared with 2.3% of untreated women. Comparable figures are much worse for DMPA users with a 35.7% incidence of irregular and 27.7% incidence of prolonged bleeding after similar duration of use. Bleeding patterns with all long-acting methods tend to improve with time. Overall group data for once-a-month injectable users are reasonably close to those of untreated women with, for example, a median of 15.6 days (5th and 95th percentiles: 7.5 and 26; confidence limits) of bleeding or spotting per 90-day reference period compared with a median of 18.5 days (5th and 95th percentiles: 12.2 and 25.5) for untreated women. Twelve-month life table discontinuation rates for menstrual bleeding disturbances are lower than expected for most progestogen-only methods at 2.1-5.2% for Cyclofem and 0.8-4.2% for Mesigyna for amenorrhea, and 6.3-12.7% for Cyclofem and 7.5-12.0% for Mesigyna for bleeding-related reasons. Once-a-month injectable contraceptives produce vaginal bleeding patterns much closer to normal than other injectables, but there are still significant deviations which lead to some discontinuation for menstrual reasons. Hence, full explanation and counselling about possible menstrual changes are still essential for all intending users of these methods.

Contraceptive Agents, Female↗
PubMed1994

Contraceptive efficacy of the Copper T 380A and Copper T 200 intrauterine devices: results from a comparative clinical trial in six developing countries.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 200 (TCu 200) intrauterine devices (IUDs) was evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a multicenter randomized clinical trial at one site in each of six developing countries. The pregnancy rate with the TCu 380A IUD was significantly lower than the pregnancy rate with the TCu 200 IUD at 12 months (0.5 and 2.6 per 100 women, respectively, p < 0.01). No statistically significant differences between the two study IUDs were found with regards to expulsion or removals due to bleeding/pain, personal, medical, or planned pregnancy. The TCu 380A IUD did not have a disproportionately higher incidence of side effects such as intermenstrual bleeding or pain, inflammations or infections, or insertion-related events compared to the TCu 200 IUD. TCu 380A IUD users, however, were significantly more likely to report increased dysmenorrhea than were TCu 200 IUD users. The performance of the TCu 380A IUD in preventing pregnancy during this trial indicates that this IUD may be a better option than the TCu 200 IUD for women wishing to practice effective, long-term, reversible birth control without having to resort to hormonal methods.

Contraception↗
PubMed1994

Clinical performance of the TCu 380A and TCu 220C IUDs in four developing country family planning clinics.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 220C (TCu 220C) intrauterine devices (IUDs) were evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at four collaborating research sites located in two developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the TCu 220C IUD at 12 months (0.3 and 0.8, respectively), although this difference was not statistically significant (p > 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. No statistically significant differences were observed in the frequency of experiencing menstrual disturbances (i.e., dysmenorrhea, intermenstrual pelvic pain or intermenstrual bleeding) between the two IUD groups. These data suggest that the TCu 380A and TCu 220C IUDs are both appropriate options for contracepting women. The TCu 380A IUD, however, may be a more appropriate option for those women wishing to space births over a longer period of time.

Adolescent↗
PubMed1994

Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age.

A comparative study of two low-dose oral contraceptives, gestodene (GES) 75 mcg/ethinyl oestradiol (EE) 30 mcg and desogestrel (DES) 150 mcg/EE 20 mcg, was conducted in women over 30 years of age. This randomised, open-label study was organised in Denmark, Italy, New Zealand and United Kingdom. A total of 505 women received GES/EE and 501 received DES/EE for 6 consecutive menstrual cycles. The two groups were comparable in terms of demographic and gynaecologic characteristics at baseline. However, the menstrual flow length was slightly longer in the GES/EE group before the start of the treatment. The mean age (+/- SD) was 35 +/- 4 years in the GES/EE group and 35 +/- 5 years in the DES/EE group. The subjects in the GES/EE group contributed data for a total of 2800 cycles and those in the DES/EE group, data for 2796 cycles. There were no pregnancies on medication with either preparation. The results showed that there were significantly more normal cycles in the GES/EE group for cycles 1 to 6. Irregular bleeding between withdrawal bleeds occurred in 10% of GES/EE and 18.5% of DES/EE cycles. Absence of all bleeding was reported in 29 (1%) and 63 (2%) cycles, respectively. The incidence of missed pills was low in both groups (11% of cycles). No significant differences were observed in cycle length or withdrawal bleeding episode length. Withdrawal bleeding mean intensity was statistically significantly greater with GES/EE. However, for both preparations, the mean intensity was close to light bleeding. No clinically significant differences were noted in weight, blood pressure, Papanicolaou smears or laboratory data. Sixty-eight (13.5%) subjects in the GES/EE group and 64 (12.8%) in the DES/EE group discontinued before the end of the study. Among them, 37 (7%) and 40 (8%) in the respective groups withdrew because of adverse reactions. There was no difference between groups in terms of primary reasons for withdrawal. The most frequently reported complaints that led to discontinuation in both groups were headache, nausea and metrorrhagia. Breast tenderness led to the discontinuation of 1 subject in the GES/EE group and 3 in the DES/EE group. These results show excellent cycle control, efficacy and very low rate of side effects with both GES/EE and DES/EE. These low-dose oral contraceptives could be well suited to healthy nonsmoking women requiring contraception up to the age of menopause.

Adult↗